Healthcare Industry News: vascular closure
News Release - October 23, 2006
Kensey Nash Receives CE Mark Approval for New ThromCat(TM) Thrombectomy Catheter SystemEXTON, Pa., Oct. 23 (HSMN NewsFeed) -- Kensey Nash Corporation (Nasdaq: KNSY ) today announced that it has received CE Mark Approval for its ThromCat(TM) Thrombectomy Catheter System, which allows the sale of the product throughout the European Union. The ThromCat(TM) System is a mechanical thrombectomy catheter designed to remove thrombus or blood clots from a patient, indicated for use in both the coronary and peripheral vasculature in Europe.
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 product has had a limited market release in the U.S. with an initial indication for use in AV grafts and fistulas. The official U.S. launch is currently underway at the Transcatheter Therapeutics (TCT) Conference in Washington, D.C., which runs October 22 through October 27.
The ThromCat(TM) device is a fully disposable catheter system that incorporates HeliFlex(TM) technology to flush, macerate, and extract thrombus. An internal rotating helix creates a powerful vacuum to draw thrombus into the catheter and then macerate it, while simultaneously flushing the vessel to aid in the thrombus removal. 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 the offering of a simple and effective device.
"Kensey Nash is now offering a full complement of simple to use, fully disposable products designed to remove dangerous clot and emboli from the arterial system in both the U.S. and Europe. The ThromCat(TM) System is designed to provide powerful thrombectomy extraction in a very simple to use, fully disposable system," commented Joseph W. Kaufmann, President and CEO of Kensey Nash Corporation. "We envision it as a device that will be useful for interventional cardiologists, interventional radiologists and also vascular surgeons to quickly and easily remove moderate to relatively heavy thrombus burdens. We believe it will be an important product within our endovascular portfolio and that it is a perfect complement to our recently launched QuickCat(TM) Extraction Catheter. In combination with our TriActiv® ProGuard and TriActiv FX® embolic protection systems, we will be able to offer our customers a broad platform of products for removing unwanted debris and thrombus from the vasculature," he said.
The ThromCat(TM) Thrombectomy Catheter System is a complementary offering to Kensey Nash's QuickCat(TM) Extraction Catheter, recently cleared in the U.S. and Europe, for the removal of thrombus from the arterial system. The QuickCat(TM) Extraction Catheter is an easy to use disposable device, designed for soft thrombus burdens. The TriActiv® ProGuard is available for sale in the European Union and the TriActiv FX® is available for sale in the U.S.
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 successfully market its endovascular products, and competition from other technologies in the embolic protection and thrombectomy markets. 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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