Healthcare Industry News: hemodialysis
News Release - July 24, 2006
Kensey Nash Receives CE Mark Approval for QuickCat(TM) Extraction CatheterEXTON, Pa., July 24 (HSMN NewsFeed) -- Kensey Nash Corporation (Nasdaq: KNSY ) today announced that it has received CE Mark approval for its QuickCat(TM) Extraction Catheter, which allows the sale of the product throughout the European Union. 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 endovascular direct sales force in Germany and through a distribution network for the rest of Europe. The QuickCat(TM) Catheter will be launched in the European Union within thirty days. In the U.S., the QuickCat(TM) Catheter received 510(k) clearance in March 2006 and is being sold by the Company's U.S. endovascular sales force.
"The QuickCat(TM) Extraction Catheter is a high-quality product offered in a rapidly expanding segment of the thrombus removal market place," commented Joseph W. Kaufmann, President and CEO of Kensey Nash Corporation. "Our QuickCat(TM) device combines reliable thrombus removal in a very deliverable product, the utility of which was recently highlighted on http:/www.TCTMD.com in a case study. We are very pleased with the product's market acceptance to date, and as we bring a full line of thrombus extraction products to market, we anticipate that the QuickCat(TM) Catheter will be an important part of the portfolio for Kensey Nash," he concluded.
The QuickCat(TM) Extraction Catheter is a complementary offering to Kensey Nash's ThromCat(TM) Thrombectomy Catheter System, recently cleared in the U.S., for the removal of thrombus from synthetic hemodialysis access grafts and native vessel dialysis fistulae, and currently under regulatory review in 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. Kensey Nash has also commercialized a series of innovative embolic protection and thrombectomy products through its own direct endovascular sales force. The Company is 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® 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 other versions of the TriActiv® System and other new endovascular products, the ability of Kensey Nash to successfully market the TriActiv® 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.
Source: Kensey Nash
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