EXTON, Pa., March 10 /PRNewswire-FirstCall/ -- Kensey Nash Corporation 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(R) 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(R) and TriActiv(R) 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.
Cautionary Note Regarding Forward-Looking Statements. This press release contains forward-looking statements that reflect Kensey Nash’s current expectations about its prospects and opportunities, including, without limitation, expectations regarding Kensey Nash’s TriActiv(R) System and its other endovascular products. Kensey Nash has tried to identify these forward- looking statements by using words such as “plans,” “believes,” “expects,” “anticipates,” “will,” “should” or similar expressions, but these words are not the exclusive means for identifying such statements. Kensey Nash cautions that a number of risks, uncertainties, and other important factors could cause Kensey Nash’s actual results, performance or achievements to differ materially from those expressed in, or implied by, these forward-looking statements, including, without limitation, the ability of Kensey Nash to obtain necessary regulatory approvals for the TriActiv FX(R), other versions of the TriActiv(R) System and other new endovascular products, the ability of Kensey Nash to successfully market the TriActiv(R) System and other endovascular products, and competition from other technologies in the embolic protection market. For a more detailed discussion of these and other factors, please see Kensey Nash’s filings with the Securities and Exchange Commission. Except as expressly required by the federal securities laws, Kensey Nash undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.
Kensey Nash Corporation
CONTACT: Joseph W. Kaufmann, President and Chief Executive Officer, KenseyNash Corporation, +1-484-713-2100
Web site: http://www.kenseynash.com/
