To: Lhn5 who wrote (689 ) 5/5/1998 6:40:00 PM From: Jeffrey L. Henken Respond to of 2887
Due Diligence on American BioMed's Atherectomy Device: Check out one of the exciting products being developed by American BioMed. The OmniCath: What is the OmniCath? americanbiomed.com The OmniCathr Atherectomy Catheter The OmniCathr is an "atherectomy catheter," designed to allow physicians to remove atherosclerotic plaque from obstructed blood vessels throughout the body, thereby enlarging vessels narrowed by plaque, increasing a patient's blood flow. This is accomplished by removing the plaque with a cutting device, leaving the vessel wall, depending on technique, clean and smooth, free of fissures, ruptures and flaps. The OmniCath is in Phase II clinical trials for peripheral use. This is use throughout the body but not in the coronary arteries. The OmniCath is also being tested for use in AV Fistula cases. americanbiomed.com americanbiomed.com americanbiomed.com What is an AV Fistula? ARTERIOVENOUS FISTULA Abnormal communication between an artery and a vein. Etiology may be congenital, in which smaller vessels are involved, or acquired as a result of acute, local trauma (eg, from a bullet or stab wound) or of erosion of an arterial aneurysm into an accompanying vein. It may cause symptoms and signs of arterial insufficiency (including ulceration due to embolization and ischemia) or of chronic venous insufficiency due to the high-pressure arterial flow within the involved veins (including peripheral edema, venous varicosities, and stasis pigmentation). If near the surface, a mass can be felt and the affected part is usually enlarged and warm, with distended and often pulsating superficial veins. A thrill can be palpated over the fistula, and a continuous machinery murmur with accentuation during systole can be heard with the stethoscope. The altered hemodynamics may cause heart failure if a significant portion of the cardiac output is diverted through the fistula. The treatment of choice is surgery, if feasible. Market analysts have estimated the worldwide market potential for the OmniCath to be over $156-million annually for this indication alone. To the best of the Company's knowledge, there is no competitor in this market segment.The overall atherectomy market for other indications exceeds $500 million a year. Look for the OmniCath to resume phase II testing in the US soon at ten sites with new protocols designed to ensure rapid approval by the FDA. The trials being done in Japan and Europe will also fall under the FDA guidelines and be used both for FDA approval and world wide marketing approvals.biz.yahoo.com Go ABMI! Regards, Jeff