Welcome to XION Medical
Please contact us for Product Information at:
info@xioncorporation.com To place an order please call us at:
P: 8004172040
Please contact us for Product Information at:
info@xioncorporation.com To place an order please call us at:
P: 8004172040
What is Edox®? Edox® is an effective, natural and safe dietary supplement whose benefit for enhancing sexual performance has been clinically proven in multiple scientific publications. Edox® consists of a patented combination of two clinically tested potent ingredients, L-Arginine asp
What is Edox®? Edox® is an effective, natural and safe dietary supplement whose benefit for enhancing sexual performance has been clinically proven in multiple scientific publications. Edox® consists of a patented combination of two clinically tested potent ingredients, L-Arginine aspartate and Pycnogenol®. These important nutrients help protect, restore, and sustain endothelial function, increase nitric oxide levels and improve vascular integrity and blood flow to the genital region. Through these mechanisms Edox® naturally enhances erectile function as well as sexual performance. Edox® taken daily will restore your sexual confidence and provide sexual wellness for you and your partner. The Ingredients comprising Edox®: L-Arginine, L-Citrulline and Pycnogenol®
L-Arginine and L-Citrulline are amino acids that are utilized by the human body to produce nitric oxide. Nitric oxide is the primary mediator responsible for the enhancement of vascular flow throughout the body including penile erections. Pycnogenol® is a natural product derived from the bark of the French maritime pine tree and has been demonstrated in clinical studies to regulate the performance of the enzyme that converts L-Arginine into nitric oxide. L-Citrulline converts to L-Arginine after supplementationTherefore, the patented combination of L-Arginine aspartate, L-Citrulline malate, and Pycnogenol® found in Edox® works synergistically to enhance erectile function and sexual performance. Why Edox®?
Edox® is an all-natural product comprised of the patented combination of Pycnogenol®, L-Arginine and L-Citrulline which has not shown signs of toxicity or harmful side effects. Furthermore, Edox® is safe, effective, beneficial and often less expensive than many of the other therapies for improving sexual performance. In addition to improving sexual performance, Pycnogenol® is a potent antioxidant with numerous additional health care benefits that include improvement in fertility status and enhancement of overall cardiovascular health. These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
What Is Erectile Dysfunction?
Erectile dysfunction (ED) also knows as impotence is the inability to attain and retain an erection that is firm enough for a man to have intercourse, or the inability to maintain an erection long enough to ejaculate inside the vagina. It can happen in one of two ways:
A man is considered to have erectile dysfunction if he is unable to get or maintain an erection in at least 50 percent of his attempts at intercourse. Erectile dysfunction is a problem for both the man and his partner. In many cases, treatment may not be necessary and the ED may resolve to some degree. In others, it may remain an issues that requires treatment. Anything that interferes with either by reducing the blood flow to the penis or increasing the blood flow out of it – can cause erectile dysfunction. Fear, anxiety, anger, or any other strong emotion can interrupt the signal from the brain. An illness or physical condition can also impair erections if it interferes with this chain of events. In most men, erectile dysfunction does not change their sexual desires, ejaculation or orgasms once he achieves and erection. Is It Physical Or Mental?
It was believed for many years psychological factors were responsible for many of cases of erectile dysfunction. Due to new diagnostic methods and more sophisticated equipment, the conclusion is that physical factors are the main cause in the majority of cases. Due to the brains involvement it does play an important role in sexual activity, thus the body and mind are connected as one. How Common Is It?
Erectile dysfunction is common problem through a man’s lifetime. Most of the men by the age of 50 years old have experiences erectile dysfunction at some point in time. According to the Massachusetts Male Aging Study complete impotence increases from 5% at the age of 40 to 15% of the males in the age group over 70 years or older. In a study conducted in the Netherlands the occurrence of some form of erectile dysfunction occurred in 20% of the males between ages50-54 and in 50% of the males between 70-78 years of age. Although sexual activity normally continues throughout a man’s lifetime, his reactions take longer as he ages. He may need more stimulation to get an erection. He may take longer to climax, and he may need to wait longer before he can get another erection. The chance of erectile dysfunction does increase with age. But erectile dysfunction can affect men at any age and at any time in their lives. What Are the Options For Erectile Dysfunction?
There are many options for erectile dysfunction in the vast majority of individuals. Most men regain their ability to have intercourse using one of the following options:
How Does Erection Normally Happen?
An erection is a cascade of events that requires the interaction of the brain, nerves, hormones, and blood vessels. This process is separate from ejaculation and orgasm, both of which can occur without an erect penis. The brain starts the process that will produce an erection due to psychological or physical stimulation.
What Can Cause Erectile Dysfunction?
The ability to achieve and sustain erections requires
Erectile dysfunction can occur if one or more of these requirements are not met. Some men are more likely to have erectile problems if they are put under emotional or physical strain. In general, seven “triggers” are linked with erectile dysfunction:
Physical causes are more common in older men, while psychological causes are more common in younger men.
Where To Find Help
The best person to approach is your own doctor, who might be able to help you or who can recommend someone else. You may be referred to a urologist, a medical specialist with advanced training to deal with issues surrounding erectile dysfunction. Summary Of Important Information Related To Erectile Dysfunction
What Is Endothelium and Function Of Endothelial Cells?
The endothelium is a thin layer of cells that lines the surface of blood vessels, forming an interface between circulating blood in the lumen and the rest of the vessel wall. These cells that line the entire circulatory system are called endothelial cells. The endothelial cells create a smooth lining which decrease turbulent flow of blood through the vessels. The involvement of Endothelial cells and its role in the body are as follows processes:
What Is Endothelial Dysfunction?
Endothelial dysfunction is a state in which the endothelial lining and the blood vessels do not respond well to vasodilating and vasoconstricting substances like nitric oxide, which is produced by the endothelium. Endothelial dysfunction can cause or be caused by many diseases such as: hypertension, hypercholesterolemia, diabetes, or environmental factors as alcohol intake, smoking tobacco products and exposure to pollution. Impaired or loss of endothelial function is frequently seen in patients with coronary artery disease, diabetes mellitus, hypertension, hypercholesterolemia, as well as in smokers and may be early signs of vascular disease or development of atherosclerosis. There have been many studies that show some correlation between endothelial dysfunction and future cardiovascular events. Impaired nitric oxide production due to oxidative stress or other mechanisms which damage the endothelial cells are the main reasons for endothelial dysfunction. Is Endothelial Dysfunction Related to Cardiovascular Disease?
Endothelial dysfunction is thought to be a key event in the development of atherosclerosis and predates clinically vascular disease sometime by many years. The reduced anticoagulant properties, oxidative stress and increased adhesion molecule expression are factors in the development of arthrosclerosis which are seen in endothelial dysfunction. Endothelial dysfunction has been shown to be of significance in predicting vascular events including stroke and heart attacks. The Role of Nitric Oxide In Endothelial Dysfunction?
In endothelial dysfunction is the inability of arteries and arterioles to dilate fully in response to release of vasodilators from the endothelium like nitric oxide (NO). Endothelial dysfunction is commonly associated with decreased NO bioavailability, which is due to impaired NO production by the endothelium and/or increased inactivation of NO by reactive oxygen species. This can be tested flow-mediated dilation, which is the most widely used non-invasive test for assessing endothelial function. This technique measures endothelial function by inducing reactive hyperemic via temporary arterial occlusion and measuring the resultant relative increase in blood vessel diameter via ultrasound. People with endothelial dysfunction have low NO bioavailability, their blood vessels have a decreased capacity to dilate in response to certain stimuli, compared to those with normal endothelial function. Because NO has anti-inflammatory and anti-proliferative effects and therefore helps inhibit atherosclerosis, it is easy to see how endothelial dysfunction may contribute to future adverse cardiovascular events. Due to the variability in such tests (e.g. due to time of day, food, menstrual cycle, temperature, etc.) means that no technique has yet been identified that would allow endothelial testing to attain routine clinical significance, the Endo-PAT is being utilized now which is a reproducible, user independent non-invasive diagnostic test, which would limit the variability’s of the test. What Are the Options For Improvement of Endothelial Dysfunction?
Exercise and improved diet has a significant impact on endothelial function. A study published in 2005 has determined that a positive relationship exists between the consumption of high fat diet and the development of endothelial dysfunction. Lifestyle modifications can improve endothelial function which include cessation of smoking, loss of weight and treatment of hypertension and hypercholesterolemia amongst other things. Some studies have found antioxidant and arginine supplementation independently and in combination can help to restore impaired endothelial dysfunction. Studies show that increasing nitric oxide production by the endothelial cells can have a positive impact on improving endothelial function. These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
Lysclare™ Restore is a Hyaluronan Soft Tissue Filling Gel
Description
Lysclare™ Restore is a colorless, transparent,
viscoelastic, biodegradable, non-pyrogenic
and sterile gel, supplied in a prefilled glass
syringe. Lysclare™ Restore consists of
cross-linked sodium hyaluronate from
biofermentation and suspended in a
physiological buffer. Sodium
Lysclare™ Restore is a Hyaluronan Soft Tissue Filling Gel
Description
Lysclare™ Restore is a colorless, transparent,
viscoelastic, biodegradable, non-pyrogenic
and sterile gel, supplied in a prefilled glass
syringe. Lysclare™ Restore consists of
cross-linked sodium hyaluronate from
biofermentation and suspended in a
physiological buffer. Sodium hyaluronate
is a natural polymer, which
is widely istributed in the extracellular matrix
in both animals and human. After slightly
cross-linking, it also has good biocompatibility.
Lysclare™ Restore is an invasive and
implantable medical device.
Lysclare™ Restore is supplied in a disposable
glass syringe with a luer-lock fitting. The
syringe is equipped with a plunger stopper,
finger grip and plunger rod and packed in a
blister together with two sterile needles,
27 G×1/2’’.
Intended purpose
Lysclare™ Restore is intended to be used for facial
tissue augmentation for dermal implantation.
Instruction for Use
Indications
Lysclare™ Restore is intended to be used for
a facial tissue augmentation for mid-to-deep
dermal implantation for the correction of
moderate to serve facial wrinkles and folds.
Intended user
Specialist in the fields of dermatology or
plastic surgery or, a medical doctor with a
knowledge of the injection techniques.
Lysclare™ Sculpt is a Hyaluronan Soft Tissue Filling Gel
Description
Lysclare™ Sculpt is a colorless, transparent,
viscoelastic, biodegradable, non-pyrogenic
and sterile gel, supplied in a prefilled glass
syringe. Lysclare™ Sculpt consists of
cross-linked sodium hyaluronate from
biofermentation and formulated to a
concentration of 20 mg/ml, suspe
Lysclare™ Sculpt is a Hyaluronan Soft Tissue Filling Gel
Description
Lysclare™ Sculpt is a colorless, transparent,
viscoelastic, biodegradable, non-pyrogenic
and sterile gel, supplied in a prefilled glass
syringe. Lysclare™ Sculpt consists of
cross-linked sodium hyaluronate from
biofermentation and formulated to a
concentration of 20 mg/ml, suspended in a
physiological buffer pH 7. Sodium
hyaluronate is a natural polymer of
repeating disaccharide units of
N-acetyl-D-glucosamine and sodium
glucuronate linked by glycosidic bonds, which
is widely distributed in the extracellular matrix
in both animals and human. After slightly
cross-linking, it also has good
biocompatibility.
Lysclare™ Sculpt is an invasive and
implantable medical device.
Lysclare™ Sculpt is supplied in a disposable
glass syringe with a luer-lock fitting. The
syringe is equipped with a plunger stopper,
finger grip and plunger rod and packed in a
blister together with two sterile needles,
27G×1/2”.
Intended purpose
Lysclare™ Sculpt is intended to be used for facial
tissue augmentation for dermal implantation.
Instruction for Use
Indications
Lysclare™ Sculpt is indicated to be used for
mid to deep dermis injection for
correction of scars or deep wrinkles or facial
rejuvenation.
Intended user
Specialist in the fields of dermatology or
plastic surgery or, a medical doctor with a
knowledge of the injection techniques.
Lysclare™ Finesse is a Hyaluronan Soft Tissue Filling Gel
Description
Lysclare™ Finesse is a colorless, transparent,
viscoelastic, biodegradable, non-pyrogenic
and sterile gel, supplied in a prefilled glass
syringe. Lysclare™ Finesse consists of
cross-linked sodium hyaluronate from
biofermentation and formulated to a
concentration of 20 mg/ml, su
Lysclare™ Finesse is a Hyaluronan Soft Tissue Filling Gel
Description
Lysclare™ Finesse is a colorless, transparent,
viscoelastic, biodegradable, non-pyrogenic
and sterile gel, supplied in a prefilled glass
syringe. Lysclare™ Finesse consists of
cross-linked sodium hyaluronate from
biofermentation and formulated to a
concentration of 20 mg/ml, suspended in a
physiological buffer pH 7. Sodium hyaluronate
is a natural polymer of repeating disaccharide
units of N-acetyl-D-glucosamine and sodium
glucuronate linked by glycosidic bonds, which
is widely distributed in the extracellular matrix
in both animals and human. After slightly
cross-linking, it also has good
biocompatibility.
Lysclare™ Finesse is an invasive and
implantable medical device.
Lysclare™ Finesse is supplied in a disposable
glass syringe with a luer-lock fitting. The
syringe is equipped with a plunger stopper,
finger grip and plunger rod and packed in a
blister together with two sterile needles,
30G×1/2” .
Intended purpose
Lysclare™ Finesse is intended to be used for facial
tissue augmentation for dermal implantation.
Instruction for Use
Indications
Lysclare™ Finesse is indicated to be used for
superficial dermis injection for correction of
fine lines and wrinkles or facial defects.
Intended user
Specialist in the fields of dermatology or
plastic surgery or, a medical doctor with a knowledge of the injection tecnique.
Lysclare™ Enhance is a Hyaluronan Soft Tissue Filling Gel
Description
Lysclare™ Enhance is a colorless,
transparent, viscoelastic, biodegradable,
non-pyrogenic and sterile gel, supplied in a
prefilled glass syringe. Lysclare™ Enhance
consists of cross-linked sodium hyaluronate
from biofermentation and formulated to a
concentration of 20 mg/ml, su
Lysclare™ Enhance is a Hyaluronan Soft Tissue Filling Gel
Description
Lysclare™ Enhance is a colorless,
transparent, viscoelastic, biodegradable,
non-pyrogenic and sterile gel, supplied in a
prefilled glass syringe. Lysclare™ Enhance
consists of cross-linked sodium hyaluronate
from biofermentation and formulated to a
concentration of 20 mg/ml, suspended in a
physiological buffer pH 7. Sodium hyaluronate
is a natural polymer of repeating disaccharide
units of N-acetyl-D-glucosamine and sodium
glucuronate linked by glycosidic bonds, which
is widely distributed in the extracellular matrix
in both animals and human. After slightly
cross-linking, it also has good
biocompatibility.
Lysclare™ Enhance is an invasive and
implantable medical device.
Lysclare™ Enhance is supplied in a
disposable glass syringe with a luer-lock
fitting. The syringe is equipped with a plunger
stopper, finger grip and plunger rod and
packed in a blister together with two sterile
needles, 27G×1/2” .
Intended purpose
Lysclare™ Enhance is intended to be used for
facial tissue augmentation for dermal implantation.
Instruction for Use
1 2
Indications
Lysclare™ Enhance is indicated to be used for
lip defects or volume enhancement.
Intended user
Specialist in the fields of dermatology or
plastic surgery or, a medical doctor with a
knowledge of the injection techniques.
In numerous scientific publications describing clinical studies conducted in both the United States and Europe, the combination of Pycnogenol® and L-Arginine has demonstrated efficacy in increasing and enhancing sexual pleasure and performance. A testament to the unassailable scientific
In numerous scientific publications describing clinical studies conducted in both the United States and Europe, the combination of Pycnogenol® and L-Arginine has demonstrated efficacy in increasing and enhancing sexual pleasure and performance. A testament to the unassailable scientific evidence supporting the effectiveness of Edox® is that the combination of Pycnogenol® and l-Arginine has been granted a patent (US6,565,851 B2) for the relief of the symptoms of ED. Several of these studies are summarized below. Treatment of Erectile Dysfunction with Pycnogenol® and L-Arginine
Stanislavov R. et al. Journal of Sex and Marital Therapy, 29(3) 207-213, 2003 40 men (aged 25-45 years) with erectile dysfunction of at least 3 months duration were studied. Initially these men where treated with L-Arginine alone for one month, and a poor response was achieved whereby only 5% of the men experienced normal erectile function. However, when Pycnogenol® was added to the regiment, a significant improvement was noted. After one month of 80 mg of Pycnogenol®/day, 80% of the men reported normal erections. This response improved in a dose dependant fashion whereby increasing the Pycnogenol® dose to 120 mg per day, 92.5% of the men experienced a return of normal erectile function. Furthermore, the study demonstrated that as one increased the dose of Pycnogenol®, the time to achieve an erection decreased and the duration of the erection increased. At a dose of 120 mg of Pycnogenol®, the duration of the erection increased to 15 ± 3 minutes. No adverse side effects were reported by the men taking Pycnogenol® and L-Arginine. The study concluded that “Supplementation with arginine and Pycnogenol® on a regular basis renders individuals with ED to be healthy lovers with a satisfying sexuality” Prelox For Improvement of Erectile Function: A Review
Lamm S. et al. European Bulletin of Drug Research 11 (3), 29-37, 2003 In a United States study performed by Dr. Steven Lamm, 37 men with erectile dysfunction who where prospectively given therapy with L-Arginine and Pycnogenol® were analyzed. 81% of the men reported that treatment with L-Arginine and Pycnogenol® had improved their ability to engage in sexual activity. An increased IIEF score was reported in 70% of the men with a 10% mean IIEF score increase for the study group as a whole. 73% of the men reported that L-Arginine and Pycnogenol® made it easier to initiate an erection and 70% stated that it made it easier to sustain an erection. A sub analysis of the study population revealed that L-Arginine and Pycnogenol® demonstrated increased efficacy particularly in men who at baseline suffered from moderate and mild erectile dysfunction. In the subgroup of men having the mildest forms of erectile dysfunction, complete restoration of their sexual function was observed. No adverse side effects were reported by the men taking Pycnogenol® and L-Arginine. The authors concluded that L-Arginine and Pycnogenol® “is effective for preserving healthy sexual function in aging men experiencing first signs of lowered erectile performance.” Improvement of Erectile Function with Prelox: A Randomized Double-Blind, Placebo Controlled, Crossover Trial
Stanislavov R. et al. International Journal of Impotence Research Mar-Apr; 20(2) 173-80, 2008 50 men (aged 30-50 years) with ED were treated in a prospective double blind fashion for one month either with placebo or a combination of L-Arginine and 80 mg of Pycnogenol®. At the conclusion of the initial treatment month, the two groups were crossed over whereby the original placebo group then received L-Arginine and 80 mg of Pycnogenol®, and the initially treated group then received placebo for an additional month. At the conclusion of the treatment period, men treated with L-Arginine and Pycnogenol® achieved normal erectile function (normal defined as an IIEF score of > 25). The treated men reported improved IIEF scores from 11-17 to 26-30. Those treated with placebo did not demonstrate a significant improvement in erectile function. On average it took approximately 5 days for the combination of L-Arginine and Pycnogenol® to improve erectile performance. The mean number of intercourse events more than doubled while on study drug. In the specific IIEF domains of orgasmic function, sexual desire, and intercourse satisfaction, significant improvement was reported. The study also noted that the improvement in erectile function following L-Arginine and Pycnogenol® intake extended beyond the treatment period, suggesting a sustained effect. Furthermore, in this study total testosterone levels also significantly improved in the group of men taking L-Arginine and Pycnogenol®. No adverse side effects were reported by the men taking Pycnogenol® and L-Arginine. The authors concluded that treatment with L-Arginine and Pycnogenol® “seems to offer a safe and very effective alternative to existing medications” for the treatment of erectile dysfunction. Endothelium –Dependant Vascular effects of Pycnogenol®.
Fitzpatrick D.F et al. Journal of Cardiovascular Pharmacology 32, 509-515, 1998 Pycnogenol® is a very powerful antioxidant that has been shown to stimulate nitric oxide synthesis. Nitric oxide is the key biological compound responsible for penile smooth muscle relaxation and vasodilatation resulting in erectile function. These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. Publications for ENDO-PAT and PAT Technology
Rozanski A, Qureshi E, Bauman M, Reed G, Pillar G, Diamond GA, Peripheral Arterial Responses to Treadmill Exercise Among Health Subjects and Atherosclerotic Patients, Circulation 2001, Vol. 103(16), 2084-2089. Chenzbraun A, Levin G, Sheffy J, Keren A, Stern S, Goor D, The Peripheral Vascular Response to Exercise is Impaired in Patients with Risk Factors For Coronary Artery Disease, Cardiology 2001, 95, 126-130. Penzel T, Brandenburg U, Fricke R, Peter JH., New methods for the non-invasive assessment of sympathetic activity during sleep, Somnologie 2002; 6(2):69-73.
Dvir I, Adler Y, Freimark D, Lavie P., Evidence for fractal correlation properties in the variations of peripheral arterial tone during REM sleep, American Journal of Physiology 2002; 283(1):H434-H439.
Pillar G, Bar A, Shlitner A, Schnall RP, Sheffy J, Lavie P. , Autonomic Arousal Index (AAI): An Automated Detection based on Peripheral Arterial Tonometry, SLEEP 2002; 25(5):543-549.
Qureshi E, Diamond GA, Chouraqui P, Saef J, Reed G, Armenia AB, Rozanski A, Usefulness of Finger Blood Flow During Exercise As A Marker Of Functionally Significant Coronary Heart Disease, American Journal of Cardiology 2002, Vol. 90, 756-9.
Karasik R, Sapir N, Ashkenazy Y, Ivanov PC, Dvir I, Lavie P, Havlin S, Correlation Differences in Heartbeat Fluctuations During Rest and Exercise, Physica Review E 66, 062902, (2002). Chouraqui P, Schnall RP, Dvir I, Rozanski A, Qureshi E, Arditti A, Saef J, Feigin PD, Sheffy J, Assessment Of Peripheral Arterial Tonometry (PAT) In The Detection Of Treadmill Exercise Induced Myocardial Ischemia, JACC, 2002, Vol. 40, 2195-2200.
Kuvin JT, Patel RP, Sliney KA, Pandian NG, Sheffy J, Schnall RP, Karas RH, Udelson JE, Assessment of Peripheral Vascular Endothelial Function with Finger Arterial Pulse Wave Amplitude, American Heart Journal, 2003, Vol. 146 number 1, 168-174.
Diwakar J, Joska TM, Edrisinghe Y, Usefulness of Peripheral Arterial Tonometry for Determining Peripheral Vascular Responses During Exercise, American Journal of cardiology, 2003, Vol. 91 506-10.
Bonetti PO, Barsness GW, Keelan PC, Schnell TI, Pummper G.M, Kuvin JT, Schnall RP, Holmes DR, Higano ST, Lerman A, Enhanced External Counterpulsation Improves Endothelial Function in Patients with Symptomatic Coronary Artery Disease, JACC 2003, Vol.41(10),1761-1768.
Fisher N, Hughes M, Gerhard-Herman M, Hollenberg NK, Flavanol-rich cocoa induces nitric-oxide-dependent vasodilation in healthy humans, Journal of Hypertension 2003, Vol. 21(12), 2281-2286.
Goor DA, Sheffy J, Schnall RP, Arditti A, Caspi A, Sheps DS, Peripheral Arterial Tonometry (PAT). A Diagnostic Method for Detection of Myocardial Ischemia Induced during Mental Stress Tests, Clinical Cardiology. 27, 2004. 137-141.
Iani C, Gopher D, Lavie P, Effects of task difficulty and invested mental effort on peripheral vasoconstriction, Psychophysiology, 41 (2004), 789-798.
Bonetti PO, Pumper GM, Higano ST, Holmes DR Jr., Kuvin JT, Lerman A, Noninvasive Identification of Patients with Early Coronary Atherosclerosis by Assessment of Digital Reactive Hyperemia, JAC
In numerous scientific publications describing clinical studies conducted in both the United States and Europe, the combination of Pycnogenol® and L-Arginine has demonstrated efficacy in increasing and enhancing sexual pleasure and performance. A testament to the unassailable scientific evidence supporting the effectiveness of Edox® is that the combination of Pycnogenol® and l-Arginine has been granted a patent (US6,565,851 B2) for the relief of the symptoms of ED. Several of these studies are summarized below. Treatment of Erectile Dysfunction with Pycnogenol® and L-Arginine
Stanislavov R. et al. Journal of Sex and Marital Therapy, 29(3) 207-213, 2003 40 men (aged 25-45 years) with erectile dysfunction of at least 3 months duration were studied. Initially these men where treated with L-Arginine alone for one month, and a poor response was achieved whereby only 5% of the men experienced normal erectile function. However, when Pycnogenol® was added to the regiment, a significant improvement was noted. After one month of 80 mg of Pycnogenol®/day, 80% of the men reported normal erections. This response improved in a dose dependant fashion whereby increasing the Pycnogenol® dose to 120 mg per day, 92.5% of the men experienced a return of normal erectile function. Furthermore, the study demonstrated that as one increased the dose of Pycnogenol®, the time to achieve an erection decreased and the duration of the erection increased. At a dose of 120 mg of Pycnogenol®, the duration of the erection increased to 15 ± 3 minutes. No adverse side effects were reported by the men taking Pycnogenol® and L-Arginine. The study concluded that “Supplementation with arginine and Pycnogenol® on a regular basis renders individuals with ED to be healthy lovers with a satisfying sexuality” Prelox For Improvement of Erectile Function: A Review
Lamm S. et al. European Bulletin of Drug Research 11 (3), 29-37, 2003 In a United States study performed by Dr. Steven Lamm, 37 men with erectile dysfunction who where prospectively given therapy with L-Arginine and Pycnogenol® were analyzed. 81% of the men reported that treatment with L-Arginine and Pycnogenol® had improved their ability to engage in sexual activity. An increased IIEF score was reported in 70% of the men with a 10% mean IIEF score increase for the study group as a whole. 73% of the men reported that L-Arginine and Pycnogenol® made it easier to initiate an erection and 70% stated that it made it easier to sustain an erection. A sub analysis of the study population revealed that L-Arginine and Pycnogenol® demonstrated increased efficacy particularly in men who at baseline suffered from moderate and mild erectile dysfunction. In the subgroup of men having the mildest forms of erectile dysfunction, complete restoration of their sexual function was observed. No adverse side effects were reported by the men taking Pycnogenol® and L-Arginine. The authors concluded that L-Arginine and Pycnogenol® “is effective for preserving healthy sexual function in aging men experiencing first signs of lowered erectile performance.” Improvement of Erectile Function with Prelox: A Randomized Double-Blind, Placebo Controlled, Crossover Trial
Stanislavov R. et al. International Journal of Impotence Research Mar-Apr; 20(2) 173-80, 2008 50 men (aged 30-50 years) with ED were treated in a prospective double blind fashion for one month either with placebo or a combination of L-Arginine and 80 mg of Pycnogenol®. At the conclusion of the initial treatment month, the two groups were crossed over whereby the original placebo group then received L-Arginine and 80 mg of Pycnogenol®, and the initially treated group then received placebo for an additional month. At the conclusion of the treatment period, men treated with L-Arginine and Pycnogenol® achieved normal erectile function (normal defined as an IIEF score of > 25). The treated men reported improved IIEF scores from 11-17 to 26-30. Those treated with placebo did not demonstrate a significant improvement in erectile function. On average it took approximately 5 days for the combination of L-Arginine and Pycnogenol® to improve erectile performance. The mean number of intercourse events more than doubled while on study drug. In the specific IIEF domains of orgasmic function, sexual desire, and intercourse satisfaction, significant improvement was reported. The study also noted that the improvement in erectile function following L-Arginine and Pycnogenol® intake extended beyond the treatment period, suggesting a sustained effect. Furthermore, in this study total testosterone levels also significantly improved in the group of men taking L-Arginine and Pycnogenol®. No adverse side effects were reported by the men taking Pycnogenol® and L-Arginine. The authors concluded that treatment with L-Arginine and Pycnogenol® “seems to offer a safe and very effective alternative to existing medications” for the treatment of erectile dysfunction. Endothelium –Dependant Vascular effects of Pycnogenol®.
Fitzpatrick D.F et al. Journal of Cardiovascular Pharmacology 32, 509-515, 1998 Pycnogenol® is a very powerful antioxidant that has been shown to stimulate nitric oxide synthesis. Nitric oxide is the key biological compound responsible for penile smooth muscle relaxation and vasodilatation resulting in erectile function. These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. Publications for ENDO-PAT and PAT Technology
Rozanski A, Qureshi E, Bauman M, Reed G, Pillar G, Diamond GA, Peripheral Arterial Responses to Treadmill Exercise Among Health Subjects and Atherosclerotic Patients, Circulation 2001, Vol. 103(16), 2084-2089. Chenzbraun A, Levin G, Sheffy J, Keren A, Stern S, Goor D, The Peripheral Vascular Response to Exercise is Impaired in Patients with Risk Factors For Coronary Artery Disease, Cardiology 2001, 95, 126-130. Penzel T, Brandenburg U, Fricke R, Peter JH., New methods for the non-invasive assessment of sympathetic activity during sleep, Somnologie 2002; 6(2):69-73.
Dvir I, Adler Y, Freimark D, Lavie P., Evidence for fractal correlation properties in the variations of peripheral arterial tone during REM sleep, American Journal of Physiology 2002; 283(1):H434-H439.
Pillar G, Bar A, Shlitner A, Schnall RP, Sheffy J, Lavie P. , Autonomic Arousal Index (AAI): An Automated Detection based on Peripheral Arterial Tonometry, SLEEP 2002; 25(5):543-549.
Qureshi E, Diamond GA, Chouraqui P, Saef J, Reed G, Armenia AB, Rozanski A, Usefulness of Finger Blood Flow During Exercise As A Marker Of Functionally Significant Coronary Heart Disease, American Journal of Cardiology 2002, Vol. 90, 756-9.
Karasik R, Sapir N, Ashkenazy Y, Ivanov PC, Dvir I, Lavie P, Havlin S, Correlation Differences in Heartbeat Fluctuations During Rest and Exercise, Physica Review E 66, 062902, (2002). Chouraqui P, Schnall RP, Dvir I, Rozanski A, Qureshi E, Arditti A, Saef J, Feigin PD, Sheffy J, Assessment Of Peripheral Arterial Tonometry (PAT) In The Detection Of Treadmill Exercise Induced Myocardial Ischemia, JACC, 2002, Vol. 40, 2195-2200.
Kuvin JT, Patel RP, Sliney KA, Pandian NG, Sheffy J, Schnall RP, Karas RH, Udelson JE, Assessment of Peripheral Vascular Endothelial Function with Finger Arterial Pulse Wave Amplitude, American Heart Journal, 2003, Vol. 146 number 1, 168-174.
Diwakar J, Joska TM, Edrisinghe Y, Usefulness of Peripheral Arterial Tonometry for Determining Peripheral Vascular Responses During Exercise, American Journal of cardiology, 2003, Vol. 91 506-10.
Bonetti PO, Barsness GW, Keelan PC, Schnell TI, Pummper G.M, Kuvin JT, Schnall RP, Holmes DR, Higano ST, Lerman A, Enhanced External Counterpulsation Improves Endothelial Function in Patients with Symptomatic Coronary Artery Disease, JACC 2003, Vol.41(10),1761-1768.
Fisher N, Hughes M, Gerhard-Herman M, Hollenberg NK, Flavanol-rich cocoa induces nitric-oxide-dependent vasodilation in healthy humans, Journal of Hypertension 2003, Vol. 21(12), 2281-2286.
Goor DA, Sheffy J, Schnall RP, Arditti A, Caspi A, Sheps DS, Peripheral Arterial Tonometry (PAT). A Diagnostic Method for Detection of Myocardial Ischemia Induced during Mental Stress Tests, Clinical Cardiology. 27, 2004. 137-141.
Iani C, Gopher D, Lavie P, Effects of task difficulty and invested mental effort on peripheral vasoconstriction, Psychophysiology, 41 (2004), 789-798.
Bonetti PO, Pumper GM, Higano ST, Holmes DR Jr., Kuvin JT, Lerman A, Noninvasive Identification of Patients with Early Coronary Atherosclerosis by Assessment of Digital Reactive Hyperemia, JACC, 2004, Vol.44 (11), 2137-2141. , 2004, Vol.44 (11), 2137-2141.
PAT Technology The preservation of your vascular health PAT (Peripheral Arterial Tone) technology is a non-invasive window to the cardiovascular system and autonomic nervous system. PAT signal technology serves as a platform which is clinically applied in Itamar Medical’s devices, in a wide variety of medical conditions. The PAT bas
PAT Technology The preservation of your vascular health PAT (Peripheral Arterial Tone) technology is a non-invasive window to the cardiovascular system and autonomic nervous system. PAT signal technology serves as a platform which is clinically applied in Itamar Medical’s devices, in a wide variety of medical conditions. The PAT based products provide early-stage detection of disease and facilitate follow-up; improving patient care while reducing the overall cost of healthcare. In order to reliably measure and monitor the PAT signal, Itamar Medical has developed convenient, easy-to-use, non-invasive proprietary finger probes. The data recorded from the probes is analyzed by advanced digital signal processing algorithms and presented to the physician by dedicated software. PAT signal acquisition The PAT signal is a measure of pulsatile blood volume changes. Knowledge of this biometric provides clinicians & researchers with a “window” into the body’s physiology and pathological states. The PAT signal is recorded from the fingertips by non-invasive, modified plethysmography-based probes. The probes are uniquely designed to optimally overcome the challenges of the measurement environment. The PAT probes impart a uniform, sub-diastolic pressure field to the distal two thirds of the fingers including their tips. This is extremely important as it:
• Prevents distal venous blood pooling that might induce the veno-arteriolar reflex (arterial vasoconstriction in sdresponse to venous distension)
• Vastly increases the dynamic range of blood volume changes by unloading arterial wall tension
• Prevents retrograde venous blood flow that might confound the measurement
• Further fixates the probe to the finger which reduces movement artifacts
Thus, the unique PAT probes facilitate the accurate, robust and user-independent measurement of the PAT Signal. PAT signal processing The PAT signal is recorded from the probes to digital media. The PAT signal is “cleaned” from noise and the data undergoes advanced digital signal processing by dedicated algorithms. The application-specific PAT software calculates the various clinical parameters in an interpreter-independent fashion. The software is easy to use and provides a user-friendly display of the data for review by the physician, with comprehensive, automatic, printable reports which include multiple test parameters and statistics. Scientific Collaboration Itamar’s collaborates with leading researchers in top medical and research institutes. The PAT technology is incorporated in advanced research programs at institutes such as the Framingham Heart Study, The Mayo Clinic, Harvard School of Medicine, Boston University, New England Medical Center, Yale University, Pittsburgh University Medical Center, Mount Sinai NY, Cedars-Sinai, Johns Hopkins University, Emory University and many more. These collaborations have yielded almost 50 peer-reviewed manuscripts and well over 100 abstracts at major scientific meetings. Intellectual property The PAT Signal and methodology has a strong intellectual property position. Four patents have been issued in the US, and several applications are currently pending. The first allowed US patent claim was very comprehensive and includes the following statement: "Monitoring changes in peripheral arterial tone and determining that a change in the physiological condition of the patient has occurred" Multiple patents were issued worldwide, with several more pending.
Endo-PAT2000 Endothelial Function Assessment with Endo-PAT2000 Endo-PAT2000 System is a noninvasive method to evaluate endothelial function. Endo-PAT2000 adds an important dimension to cardiovascular prevention by enabling physicians to reliably measure endothelial function and identify pathological cases of endothelial dysfunction. Endothelial dysfunction is the earliest clinically detectable stage of cardiovascular disease. Endothelial Function Applications:
• Basic science and clinical research
• Pharmacological protocols - assessment of drug efficacy
• Primary prevention of Coronary Artery Disease (CAD) - implementation of clinical protocols for early diagnosis
• Evaluation of treatment protocols
Endo-PAT2000 is an easy to use, office-based device for assessing endothelial function. The PAT signal is recorded using Itamar Medical's, noninvasive, pneumatic, finger bio-sensor. The data recorded is analyzed automatically. Advanced Digital Signal Processing (DSP) algorithms and reports are available within seconds of completing the test. Endo-PAT2000 – Assessing Endothelial Function
• Noninvasive
• Easy to use
• User independent
• Automatic data analysis
• Supports both clinical and research applications
• Reliable and reproducible results
• FDA cleared and CE marked
The medical community has long sought a cost-effective, reliable, and non-invasive method to detect endothelial dysfunction. A noninvasive technology that could accurately and reliably enhance the examination and follow-up for cardiac disease patients. Itamar Medical's Endo-PAT2000 is meeting this challenge, enhancing the traditional clinical settings’ diagnostic capabilities for endothelial dysfunction. The Endo-PAT2000 can be used in any setting, from hospital bedside to outpatient clinic. The Endo–PAT2000 provides a very high degree of sensitivity and specificity as compared to the current Gold Standard of coronary artery endothelial function assessment – the coronary blood flow response to intra-coronary acetylcholine-infusion. The Mayo Clinic’s Cardiology Center in Minnesota conducted a study in which 94 subjects underwent both an angiographic assessment of endothelial function in the coronaries and Endo-PAT examinations. The PAT RH index yielded a sensitivity of 82% and a specificity of 77% compared to intra-coronary endothelial function tests (see below). About cardiovascular disease
Cardiovascular Disease: The Facts Cardiovascular disease (CVD) is the #1 killer in the world. In 2004 cardiovascular disease claimed the lives of nearly 900,000 people in the USA alone. Of these, 650,000 lives were lost due to Coronary Heart Disease (CHD), the deadliest CVD. An estimated $431.8 billion was spent in direct and indirect CVD hospital costs in 2007. Advances in treatments for cardiovascular disease (i.e. open heart surgery and catheterization procedures) have had a major impact on improving the length and quality of life for patients with cardiovascular disease. Unfortunately, about 2/3 of unexpected cardiac deaths occur without prior recognition of cardiac disease.3 Cardiovascular disease is usually the result of a process which takes years, even decades, to form. This process is called subclinical atherosclerosis. As it becomes clinically overt, it is known as atherosclerosis. When the clinical manifestations become evident, CVD prevention becomes far more difficult. The challenge is to assess atherosclerotic disease while it is still considered subclinical. Vascular Health
Atherosclerosis – when vascular health fails Atherosclerosis (Greek: Athero = gruel or porridge, Sclerosis = toughening or hardening) is the irreversible and progressive build up of plaque in the arteries. It is a complex process originated by endothelial dysfunction, and includes the accumulation of cholesterol inside the arterial wall, with local inflammation and coagulation reactions, oxidative processes, and many other conditions, which contribute together to plaque growth. There are many risk factors, which cause people to be more susceptible to atherosclerotic plaque formation and the resultant cardiovascular disease. These risk factors include smoking, Diabetes, high blood pressure, age, genetics, high LDL levels (“bad” cholesterol), low HDL levels (“good” cholesterol), sedentary lifestyle, and several others. Subclinical atherosclerosis is divided into several stages; the earliest is known as the “fatty streak”. In this stage, the plaque continues to build up over time, transforming from a quiescent subclinical phase (see above) to a clinical phase. Plaque in the coronary circulation will predispose people to angina pains, heart attacks and heart failure. Plaque in the neck and head increases the risk of dementia and strokes. Plaque can also form in the arteries, supplying blood to the limbs, causing claudication, while in the penile circulation it is the cause of erectile dysfunction. Plaque also leads to blood clots which may detach, and cause embolisms. Vulnerable Plaque – acute danger When plaques form in small increments, they can lead to heart attacks and strokes. In these cases, plaques are at a higher risk of rupturing, which leads to an acute and catastrophic cascade of events. When a plaque ruptures it causes immediate coagulation and a concomitant constriction of the artery, blocking off the blood supply to downstream tissues, which causes ischemia and then necrosis. This is the most common mechanism of heart attacks and strokes. As a result, these unstable plaques have been nicknamed “vulnerable plaques”. While they usually account for about 10-20% of the plaques, they cause around 80-90% of the acute events. In the USA alone there are about 1.5 million heart attacks every year. Stable Plaque – chronic disease When the plaques mature and stabilize, they begin to slowly occlude the blood vessel. Natural collateral blood vessels can form to supply the tissues suffering from lack of oxygen due to the blockage. Often these collaterals are insufficient and during times of exertion patients feel pain due to ischemia. This is the typical case of Angina Pectoris (Greek: Angina = pain, Pectoris = Chest).
Endothelial Dysfunction
What is Endothelial Dysfunction? The endothelium is the inner lining of blood vessels, serving as an interface between them and the blood. It allows blood to flow smoothly within blood vessels. In 1980, scientists discovered that the endothelium is more than just a "Teflon like” lining – it’s actually the largest secreting organ in the body. The endothelium is a highly active organ which is involved in regulating homeostasis through numerous functions such as, blood pressure, inflammatory processes and coagulation. In 1998 Robert F Furchgott, Louis J Ignarro and Ferid Murad were awarded the Nobel Prize in medicine for this important discovery.
What is endothelial function? The “normal” or healthy endothelium is involved in regulating homeostasis by secreting substances which protect vascular health. Chief among these substances is Nitric-Oxide – a two atom molecule, which is considered to be the hallmark of normal endothelial function. Together with several other substances, Nitric Oxide is involved in locally regulating processes such as
• Vascular tone
• Inflammation
• Coagulation
• Oxidation
If these processes are not strictly regulated, they can lead to impairment of vascular health, leading the way to subclinical atherosclerosis, all the way to cardiovascular disease.
Endothelial dysfunction Endothelial Dysfunction is the result of the cumulative damage to the endothelium by cardiovascular disease risk factors such as genetics, smoking, Diabetes, high blood pressure and others. These risk factors cause the endothelium to malfunction: it secretes less of the protective molecules, such as Nitric-Oxide, and secretes substances which promote atherosclerotic plaque formation. Leading doctors at the Mayo Clinic proclaimed in a 2003 paper that “endothelial dysfunction may be regarded as the 'ultimate risk of the (cardiovascular) risk factors.'" It was identified as the missing link between cardiovascular risk factors and subclinical atherosclerosis. Endothelial dysfunction is now widely recognized in the medical community as the earliest clinically-detectable indication of heart disease. Unlike subclinical atherosclerosis, endothelial dysfunction, with proper treatment, is reversible. How is endothelial dysfunction diagnosed? Until recently, experts used various methods to assess endothelial function. These methods are categorized as either: Invasive - which is painful and with a certain amount of risk; or Noninvasive – which is user-dependent, meaning test results are prone to high variability between users, limiting its use to expert research sites. To diagnose something as serious as endothelial dysfunction, a method is needed that can function with consistent accuracy, independently of the user. The Endo-PAT provides this combination of noninvasive, ease-of-use, independent of the user, while providing reliability. It has been scientifically validated in close to a hundred publications from clinical studies in top research centers (e.g., Framingham Heart Study, Harvard, Mayo Clinic and hundreds of others) around the world and is the method used to assess endothelial function in leading centers. In order to avoid confusion, please note that there are several noninvasive methodologies to assess cardiovascular disease risk. But all of them target subclinical atherosclerosis, which is when vascular health has already been compromised to a certain extent. This degeneration of the vasculature is irreversible. While endothelial dysfunction plays a key role throughout these phases of the atherosclerotic disease, it is not what these tests of cardiovascular risk measure. Resources: Bonetti OP, Lerman LO, Lerman A: Endothelial Dysfunction: A Marker of Atherosclerotic Risk Arterioscler. Thromb. Vasc. Biol. 23, 168-175, 2003 Erectile dysfunction
How are erectile dysfunction and cardiovascular disease connected? In recent years investigators have observed that the onset of erectile dysfunction is often followed a few years later by the onset of cardiovascular events1. The evidence is pointing towards endothelial function as the clinical connection between these two afflictions. This is hardly surprising, as endothelial dysfunction is a systemic disease, afflicting multiple target organs. Endothelial dysfunction is increasingly recognized as the root cause of atherosclerotic plaque formation. Its clinical manifestations are coronary artery disease, erectile dysfunction, stroke and other cardiovascular diseases. The clinical implications of endothelial dysfunction are so grave that in 2003 investigators from the Mayo Clinic stated that “endothelial dysfunction may be regarded as the ultimate risk of the risk factors” 2. The impact of these new findings on patient management is immense: from viewing erectile dysfunction as a harbinger of future cardiovascular events3, to prevention of erectile dysfunction itself.
Erectile dysfunction and cardiovascular disease – size matters! The degenerative remodeling of the vascular walls is a silently progressive process called subclinical atherosclerosis. It develops over years, even decades. Usually, smaller vessels, such as in the penile vasculature, become occluded more quickly than larger vascular beds, such as the coronaries. This means that, generally, erectile dysfunction will have an earlier clinical presentation than in the larger coronaries. Lately urologists are beginning to equate endothelial dysfunction with erectile dysfunction4. In 2006 the European Urology Association pointed to office-based endothelial function tests as useful in stratifying cardiovascular disease risk in patients who present with erectile dysfunction. The obvious goal is to detect cardiovascular disease progression while it is still in its subclinical stages. As endothelial dysfunction is the earliest clinically detectable stage of cardiovascular diseases, it is a prime candidate for this purpose. What makes endothelial dysfunction even more appealing is that it is treatable, and unlike the plaque, even reversible. This means that monitoring endothelial function provides clinicians with both better management of erectile dysfunction, as well as better control of cardiovascular disease risk. References:
• 1. IM Thompson et al.; “Erectile Dysfunction and Subsequent Cardiovascular Disease” JAMA2005; 294:2996-3002
• 2. PO Bonetti et al.: “Endothelial Dysfunction A Marker of Atherosclerotic Risk” Arteriosclerosis, Thrombosis, and Vascular Biology. 2003;23:168
• 3. RA. Kloner; “Erectile Dysfunction: The New Harbinger for Major Adverse Cardiac Events in the Diabetic Patient” J Am Coll Cardiol 2008 51: 2051-2052
• 4. A Muller, JP Mulhall; “Cardiovascular disease, metabolic syndrome and erectile dysfunction” Current Opinion in Urology; November 2006;16(6):435-443
Further reading: The connection between erectile dysfunction and endothelial dysfunction:
• Tamler R, Bar-Chama N. “Assessment of endothelial function in the patient with erectile dysfunction: an opportunity for the urologist” International Journal of Impotence Research,2008 ,1-8
• H Solomon et al.; “Erectile dysfunction and the cardiovascular patient: endothelial dysfunction is the common denominator.” Heart 2003; 89; 251-253
The connection between endothelial dysfunction and cardiovascular disease:
• Celermajer, David S. “Reliable Endothelial Function Testing: At Our Fingertips?” Circulation 2008; 117(19): 2428-2430
• JE Deanfield et al.; “Endothelial Function and Dysfunction: Testing and Clinical Relevance” Circulation 2007; 115;1285-1295
The timeline of progression between erectile dysfunction and cardiovascular disease:
• IM Thompson et al.; “Erectile Dysfunction and Subsequent Cardiovascular Disease” JAMA2005; 294:2996-3002
Watch-PAT Diagnose obstructive sleep apnea with Watch-PAT200 Watch-PAT200 System The Watch-PAT200 provides a new screening, diagnostic, treatment assessment and patient follow-up possibilities in the medical management of sleep-related breathing disorders. The Watch-PAT200 is designed to fulfill the unmet need for an ambulatory, reliable, patient friendly diagnostic evaluation tool that is accessible to the great number of OSA sufferers, and to the equally important need for a cost effective means for follow up of treated patients. The Watch-PAT200 opens new clinical avenues for the practice of sleep medicine. The Watch-PAT200 is a self-contained device that is worn on the wrist and uses a non-invasive finger mounted pneu-optical probe to measure the PAT signal. The recorded signals are stored in a removable memory card in the device to be downloaded to a computer for automatic analysis utilizing proprietary algorithms. In addition to the PAT Signal, the Watch-PAT200 records oxygen saturation and actigraphy. A fourth channel, pulse rate, is derived from the PAT Signal. The Watch-PAT200 offers physicians and the millions of undiagnosed sufferers of obstructive sleep apnea a new option for ambulatory, patient-friendly, unattended first line diagnostic evaluation of sleep related breathing disorders. Watch-PAT200
• Diagnosis, treatment assessment and follow-up of sleep-related breathing disorders
• Minimal sleep interference
• Non-invasive finger probes pose no patient risk
• Ambulatory, comfortable and convenient for unattended home use
• Advanced automatic analysis and digital signal processing algorithms
• Automatic scoring presented in a comprehensive report
• Single button operation
• Records and stores data on removable media
Watch-PAT200 is FDA cleared and CE certified
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