Healthcare Industry News: vascular closure
News Release - April 27, 2006
Kensey Nash Receives FDA 510(k) Clearance for New ThromCat(TM) Thrombectomy Catheter SystemCompany Is Preparing for Market Launch Within 90 Days
EXTON, Pa., April 27 (HSMN NewsFeed) -- Kensey Nash Corporation (Nasdaq: KNSY ) today announced that it has received 510(k) clearance for its ThromCat(TM) Thrombectomy Catheter System from the U.S. Food and Drug Administration (FDA). The ThromCat(TM) System is a thrombectomy catheter designed to remove thrombus or blood clots from a patient, with an initial indication for use in AV grafts and fistulas. The Company plans to study the utility of the device for application in additional vessels in the coming year.
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 macerates 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.
"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 FX® System, which achieved a low MACE rate of 3.2% in the ASPIRE trial and is pending FDA clearance, we will be able to offer our customers a broad platform of products for removing unwanted debris and thrombus from the vasculature. The ThromCat(TM) System is expected to be launched within the next ninety days," he said.
The ThromCat(TM) System will be sold through Kensey Nash's direct U.S. endovascular sales force. CE Mark approval, to allow the sale of the ThromCat(TM) System in the European Union, is also currently pending.
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. The recently launched QuickCat(TM) Extraction Catheter and the ThromCat(TM) Thrombectomy System are the Company's newest 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® 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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