Kensey Nash Receives FDA 510(k) Clearance for QuickCat(TM) Extraction Catheter
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EXTON, Pa., March 10 -- Kensey Nash Corporation (NASDAQ:KNSY) today announced that it has received 510(k) clearance for its QuickCat(TM) Extraction Catheter from the U.S. Food and Drug Administration. The QuickCat(TM) Catheter is an aspiration catheter indicated for the removal of fresh soft emboli and thrombi (blood clots) from vessels in the arterial system.
The QuickCat(TM) Extraction Catheter is an easy-to-use, fully disposable aspiration system that rapidly removes thrombus from the body. The device will be sold through Kensey Nash's direct U.S. endovascular sales force and will be exhibited for the first time at the upcoming American College of Cardiology Meeting in Atlanta, Georgia, March 11-14, 2006.
"The QuickCat(TM) Extraction Catheter was developed by Kensey Nash, along with our ThromCat(TM) Thrombectomy System, to offer physicians a full product line of thrombus extraction products," commented Joseph W. Kaufmann, President and CEO of Kensey Nash Corporation. "The QuickCat(TM) combines a high level of deliverability and ease of use with reliable thrombus removal. We are looking forward to launching this product very shortly," he concluded.
The QuickCat(TM) Catheter will be a complementary offering to Kensey Nash's ThromCat(TM) Thrombectomy Catheter System, currently under regulatory review in the U.S. and Europe. The ThromCat(TM) System is a more powerful mechanical device with Heliflex(TM) technology, designed to remove more organized thrombus. According to industry sources, the current market for thrombectomy catheter systems approximates $100 million worldwide, including the coronary market. The Company believes that the worldwide market could expand with products that are not only effective, but also easy to use.
About Kensey Nash Corporation
Kensey Nash Corporation is a leading medical technology company providing innovative solutions and technologies for a wide range of medical procedures. The Company provides an extensive range of products into multiple medical markets, primarily in the endovascular, sports medicine and spine markets. Many of the products are based on the Company's significant expertise in the design, development, manufacturing and processing of absorbable biomaterials, which has led to partnerships to commercialize technologies. Recently, the Company has created an endovascular division to launch its novel TriActiv® Embolic Protection System, a device designed to prevent debris from traveling downstream from the treatment site during stenting procedures. Kensey Nash is bringing several versions of the device to market, including the TriActiv FX® and TriActiv® ProGuard(TM) Systems, and is also planning to launch the ThromCat(TM) Thrombectomy System and QuickCat(TM) Extraction Catheter as new endovascular products. Kensey Nash is also known as a pioneer in the field of arterial puncture closure, as the inventor and developer of the Angio-Seal(TM) Vascular Closure Device, which is licensed to St. Jude Medical, Inc.
Source: Kensey Nash Corporation
CONTACT: Joseph W. Kaufmann, President and Chief Executive Officer,
Kensey Nash Corporation, +1-484-713-2100
Web site: http://www.kenseynash.com/
