American BioMed Inc.'s OmniCath atherectomy catheter receives favorable FDA review.THE WOODLANDS, Texas--(BUSINESS WIRE)--June 21, 1996--American BioMed Inc. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB:ABMI), of The Woodlands, Thursday announced that the company received a favorable review from the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for the use of its OmniCath(r) atherectomy catheter as an adjunct to balloon angioplasty in the treatment of partial stenosis of arteriovenous arteriovenous /ar·te·rio·ve·nous/ (-ve´nus) both arterial and venous; pertaining to or affecting an artery and a vein. ar·te·ri·o·ve·nous adj. Abbr. grafts. The FDA encouraged the company to submit a U.S. Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) application so that clinical trials can begin in the United States. The company will proceed to develop a randomized clinical investigation utilizing UCLA Medical Center UCLA Medical Center is a hospital located on the campus of the University of California, Los Angeles in Los Angeles, California. It is rated as one of the top three hospitals in the United States and is the top hospital on the West Coast according to US News & World Report. as its Central Monitoring Center. The company intends to file a 510(k) Notification for this indication as soon as the clinical investigations are completed. The company also announced that, in cooperation with its Principal Clinical Investigator, Dr. Samuel S. Ahn, it has filed an IRB IRB See: Industrial Revenue Bond (Institutional Review Board) at UCLA to conduct a multi-center prospective randomized study comparing atherectomy using the OmniCath(r) device vs. balloon angioplasty to treat Peripheral Arterial Occlusive Disease. Upon conclusion of these clinical investigations, the company will submit an additional 510(k) Notification to the FDA for peripheral use of its OmniCath(r) atherectomy catheter. American BioMed Inc. utilizes state of the art technology to develop, manufacture and market minimally invasive medical, surgical and diagnostic devices which deliver unique advantages through advanced science. Over 25 patents cover its technologies competing in an industry with combined markets estimated at over $10 billion annually. The devices include but are not limited to the OmniCath(r) atherectomy catheter, as well as the company's nine patented FDA approved unique all-silicone balloon catheters. These consist of thermodilution heart, thrombectomy thrombectomy /throm·bec·to·my/ (throm-bek´tah-me) surgical removal of a clot from a blood vessel. throm·bec·to·my n. Excision of a thrombus. , urinary bladder and angioscopy catheters. The OmniStent(tm) and accompanying stent technology is used to support diseased blood vessels. Other devices such as minimally invasive spinal instruments are also under development. CONTACT: Thomas E. Waite & Associates Inc. 407/324-1606, fax 407/324-0664 |
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