Healthcare Industry News:  vascular closure 

Devices Interventional FDA

 News Release - January 23, 2006

Kensey Nash Submits TriActiv FX(R) Embolic Protection System 510(k) Application to FDA

EXTON, Pa., Jan. 23 (HSMN NewsFeed) -- Kensey Nash Corporation (Nasdaq: KNSY ) today announced that it has submitted an application for 510(k) clearance for its TriActiv FX® Embolic Protection System to the U.S. Food and Drug Administration based on data collected from the ASPIRE (Angioplasty in SVGs with Post Intervention Removal of Embolic Debris) Study which was completed by the Company in November. Data from the Study will be released at the upcoming American College of Cardiology (ACC) conference in March 2006 in Atlanta, Georgia.

"The TriActiv FX® System is designed to provide an extremely simple and comprehensive solution for physicians and patients during stenting procedures in diseased SVGs," stated Joseph W. Kaufmann, President and CEO of Kensey Nash Corporation. The data from the ASPIRE trial, which supported this submission, is compelling and suggests that we have achieved significant advancements in embolic protection technology. We are looking forward to introducing this second generation TriActiv® System and the other 510(k) pending products, the ThromCat(TM) System and the QuickCat(TM) Catheter, to our customers at the ACC," he concluded.

The TriActiv FX® System incorporates several important ease-of-use design enhancements to the TriActiv® System platform. These include a new balloon inflator that simplifies catheter exchanges during the procedure, and a new flush catheter design to enhance device usage and reduce procedure time.

The TriActiv FX® Embolic Protection System, ThromCat(TM) Thrombectomy Catheter System and QuickCat(TM) Extraction Catheter will be sold through Kensey Nash's newly created direct U.S. endovascular sales force.

The TriActiv FX® System is designed to prevent heart attacks during the interventional treatment of saphenous vein grafts (SVGs) in patients who previously received coronary bypass surgery, but now have blockages in the grafts. The device incorporates three important features to address the common problem of distal embolization - a protection balloon guidewire that creates a protected space, a flush catheter that washes the graft, and an automated extraction system that removes the debris found in the graft. These three features work in combination to prevent the debris found in the graft from embolizing and potentially causing a heart attack. The TriActiv® ProGuard(TM) System is another version of the System that is currently in clinical studies to evaluate its performance in preventing strokes and other adverse events during carotid stenting procedures.

About Kensey Nash Corporation. Kensey Nash Corporation is a leading developer and manufacturer of absorbable biomaterials-based products with applications in the cardiology, orthopaedics, spine, drug and biologics delivery, periodontal/dental, surgical and wound care markets. The Company was 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. The TriActiv® System, a novel embolic protection system, is cleared for sale in the U.S. TriActiv FX® System, the second generation of the TriActiv® System, is approved for sale in the European Union. Regulatory clearance for the TriActiv FX® is pending in the U.S.

Cautionary Note for Forward-Looking Statements. This press release contains forward-looking statements that reflect the Company's current expectations about its prospects and opportunities. The Company tried to identify these forward-looking statements by using words such as "expects," "anticipates," "estimates," "plans," "will," "forecasts," "speculates," or similar expressions, but these words are not the exclusive means for identifying such statements. The Company cautions that a number of risks, uncertainties, and other important factors could cause the Company's actual results to differ materially from those in the forward-looking statements including, without limitation, demand for and the Company's ability to develop and manufacture biomaterial products, additional regulatory approvals, and competition from other technologies in the marketplace. For a more detailed discussion of these and other factors, please see the Company's SEC filings. Except as expressly required by the federal securities laws, the Company 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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