BACCHUS VASCULAR GETS IDE FOR DEEP VEIN THROMBOSIS SYSTEM.Bacchus Vascular, Santa Clara, Calif., has received 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. approval of an 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) for the treatment of Deep Vein Thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. (DVT See deep vein thrombosis. ). Deep vein thrombosis occurs when blood clots form in the deep blood vessels of the legs. These blood clots can block flow from the legs back to the heart and lungs. In some cases clot pieces may travel to the lungs, which can be fatal. Approximately 400,000 Americans are affected by DVT annually. The Bacchus Fino(TM) System is a proprietary minimally invasive device designed to remove blood clots from peripheral veins. The Fino enables rapid disruption and removal of deep vein thrombus. Physicians have already used the Fino System to successfully treat patients in Europe, Australia and Argentina. "The Fino system represents the advances and innovations that Bacchus Vascular has made in thrombus removal. We are very pleased that the Fino System has already received its IDE approval," said Mel Schatz, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and president of Bacchus Vascular. "We are confident that physicians will use these tools to successfully treat patients with deep vein thrombosis." About Bacchus Vascular Bacchus Vascular, Inc. is a rapidly emerging company focused on the discovery and development of innovative treatments for cardiovascular and peripheral vascular occlusive disease. Bacchus Vascular was founded in 1999 by Thomas J. Fogarty, M.D. Dr. Fogarty has over forty years of experience in the development of embolectomy embolectomy /em·bo·lec·to·my/ (em?bo-lek´tah-me) surgical removal of an embolus. em·bo·lec·to·my n. Surgical removal of an embolus. embolectomy surgical removal of an embolus. and 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. products. Dr. Fogarty has pioneered the field of minimally invasive surgery minimally invasive surgery Laparoscopic surgery, see there. See Laparoscopic cholecystectomy. through his inventions and in the process redefined how cardiovascular, vascular, and general surgeries are performed today. Since its inception, Bacchus Vascular has developed different and innovative lines of patented percutaneous products, including the Trellis and Solera systems. Both have recently received 510(k) clearance and are CE-Marked. The company believes that it is strategically well positioned for leveraging its unique technologies into becoming the leader in Thrombus Management. "Bacchus Vascular continues to build on its strong medical technology and add to its well regarded product family. We are extremely proud of this new Fino platform, and believe that it represents the most advanced generations of thrombectomy catheters," noted Dr. Fogarty. For more information, call 408/980-8300 ext. 242 or visit http://www.bacchus-vascular.com. |
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