EXTON, Pa., Nov. 3 /PRNewswire-FirstCall/ -- Kensey Nash Corporation today announced that it has commenced a trial of the new version of the TriActiv(R) Embolic Protection System for carotid stenting procedures in a European Pilot study. The study will support a CE Mark application, expected in 2006, for use of the TriActiv(R) Embolic Protection System during carotid stenting procedures.
The trial is utilizing the Company’s newest version of the TriActiv(R) System product line, which incorporates Local Flush and eXtraction (LFX(TM)) technology designed for use in branched arteries, such as those of the carotid blood vessels. The TriActiv(R) ProGuard(TM) System incorporates three features designed to reduce the incidence of embolic stroke during carotid stenting procedures - a balloon protection guidewire, a flush catheter, and an automated extraction system to remove debris. The system will be studied and can be used in combination with any approved stent on the marketplace. Prof. Horst Sievert, M.D., CardioVascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany is serving as principal investigator for the European study.
“I have been impressed with the new TriActiv(R) ProGuard(TM) System in its ability to handle very complex carotid cases with relative ease,” commented Prof. Dr. Sievert. “In one of my very first cases with the device, we navigated extremely tortuous anatomy and used the System to prevent significant debris from adversely impacting the patient. Embolic protection is such an essential aspect of successful carotid stenting procedures and physicians require an easy-to-use and clinically effective device. The TriActiv(R) System’s combination of balloon protection, flushing and automated extraction in one device may provide a useful alternative for us and a comprehensive solution to our challenges,” he concluded. Prof. Dr. Sievert performed two of his initial three cases in front of a live audience at the world’s largest congress dedicated to carotid stenting, his 5th International Course on Carotid Angioplasty and other Cerebrovascular Interventions (ICCA) in Germany, which highlighted new technologies and methods used in carotid stenting.
Separately, the Company announced that the U.S. Food and Drug Administration (FDA) has approved KNC’s IDE submission to commence a similar feasibility study in the U.S. The carotid study in the U.S. is scheduled to start this month.
“The initiation of our carotid trials is another significant milestone for our company,” said Joe Kaufmann, President and CEO of Kensey Nash Corporation. “Carotid stenting is a relatively new, yet rapidly growing, target market for our embolic protection technology. As part of our strategy for growing our endovascular business, we are executing our plan to expand our embolic protection indications and product portfolio. The carotid stenting market provides our company a unique opportunity to offer the medical community an alternative to the filter based systems,” he concluded.
Carotid artery disease would be an additional target indication for the TriActiv(R) product offering that includes TriActiv(R), TriActiv(R)FX(TM), and the new investigational TriActiv(R) ProGuard(TM) Systems. Each year, there are over 200,000 surgical endarterectomies performed worldwide to treat carotid artery disease. It is also known that a significantly larger number of patients are affected by the disease, with many going untreated due to the invasiveness of a surgical procedure. With the advent of carotid stenting in combination with embolic protection devices continuing to show promising results, the Company believes that carotid stenting will become the standard of care for the treatment of carotid artery disease.
The TriActiv(R) System is currently indicated to prevent heart attacks during the treatment of saphenous vein grafts (SVGs) in patients who previously received coronary bypass surgery, but now have blockages in the grafts. The Company is launching the product in the U.S. through a dedicated sales force. The TriActiv(R) FX(TM) System, the second generation of the TriActiv(R) System, is commercialized in Europe and has been studied in the 100-patient ASPIRE Study registry to support clearance in the U.S.
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(R) System, a novel embolic protection system, is cleared for sale in the U.S. TriActiv(R) FX(TM) System, the second generation of the TriActiv(R) System, is approved for sale in the European Union and has been studied in a clinical trial to gain regulatory clearance 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,” 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.
Kensey Nash Corporation
CONTACT: Joseph W. Kaufmann, President and CEO, Kensey Nash Corporation,+1-610-524-0188
Web site: http://www.kenseynash.com/
