To: R.C.L. who wrote (18 ) 3/5/1998 12:41:00 AM From: Jeffrey L. Henken Respond to of 2887
I thought I would post the press release on FDA approval of the AHN CATHETER since Yahoo seems to think it never happened: AMERICAN BIOMED RECEIVES FDA APPROVAL TO MARKET NEW, SAFER THROMBECTOMY CATHETER - Company Files Patent Application with the U.S. Patent and Trademark Office - The Woodlands, Texas, January 20, 1998 - American BioMed, Inc. (OTC Bulletin Board: ABMI), a manufacturer of minimally invasive medical devices for the treatment of cardiovascular disease, today announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for a new, safer thrombectomy catheter for the treatment of thromboemboli, the removal of clots from blood vessels. The product will be named the Ahn (dual balloon) thrombectomy catheter after Dr. Samuel S. Ahn, of the University of California, Los Angeles, developer of the product and American BioMed's Principal Clinical Investigator. This unique catheter incorporates a distal dual balloon design to more effectively remove emboli, as well as a proximal indicator safety balloon that allows the surgeon to visually determine inflation volume. A patent application has been filed with the U.S. Patent and Trademark Office for this product, and the company expects to launch the product in the second quarter of 1998. Dr. Ahn stated, "This new thrombectomy catheter has many important advantages over existing catheters on the market today. The proximal indicator safety balloon prevents over-inflation, reducing balloon ruptures and injury to the blood vessel. As a result, the procedure is safer and fewer balloons are used. In addition, the unique design of the distal dual balloon traps blood clots more effectively and prevents contamination caused by blood spurting into the operator's face and eyes. Lastly, its 100% silicone-based design decreases the potential risk of an allergic reaction. We believe this new catheter should make thrombectomy and embolectomy procedures safer, easier and more effective, and may offer significant cost reduction." Commenting on the announcement, Steven B. Rash, president and chief executive officer, added, "There is increasing acceptance in the medical community for 100% silicone-based catheters, and we believe this product offers key advantages over alternative latex products. Approval of the Ahn thrombectomy catheter represents an important milestone in American BioMed's history. This marks the company's first fully independent completion of the entire FDA market approval process for an internally developed product, and validates the company's ongoing research efforts and commitment to manufacturing quality. Its also confirms our ability to bring new, innovative product technologies to market." The company's second internally developed product, a 100% silicone-based bi-lumen balloon catheter utilizing the company's dual balloon technology, is currently pending FDA approval. The company plans to introduce four models of this new generation bi-lumen catheter upon approval. With the addition of the Ahn thrombectomy catheter, the company now has ten FDA-cleared balloon catheters. The 100%-silicone design of these catheters is resistant to environmental factors, unaffected by body temperature and more bio-compatible than latex balloons or polyvinyl chloride tubing. The patented one-piece balloon design eliminates glue and ties, providing superior smoothness and preventing the possibility of balloon dislodgement. Allergy to latex has been increasingly recognized as a cause of life-threatening intraoperative anaphylaxis (a systemic reaction). Frequent use of latex in patients or by healthcare workers can result in sensitization that may place some individuals at risk for life-threatening allergic reactions. The 100%-silicone design of the company's catheters negates the potential risk of intraoperative anaphylaxis. American BioMed, Inc. utilizes state-of-the-art technology to develop, manufacture and market minimally-invasive medical, surgical and diagnostic devices for the treatment of cardiovascular disease. The company's products include: 100% silicone-based catheters, through its Cathlab subsidiary; the Evert-O-Cath™, a toposcopic catheter for site-specific drug delivery and fluid removal; the OmniCathr, an atherectomy catheter designed to remove athersclerotic plaque from obstructed blood vessels throughout the body; the OmniStent™, which uses stent technology for angioplasty and atherectomy procedures; and the OmniFilter, which is used to prevent blood clots from reaching various organs of the body. The company has over twenty five patents covering its product portfolio, and the combined worldwide market is estimated at over $10 billion annually. American BioMed Minimally Invasive TechnologyRegards, Jeff