EXTON, Pa., April 26 /PRNewswire-FirstCall/ -- Kensey Nash Corporation today announced that it has completed enrollment of a pilot trial for its TriActiv(R) ProGuard(TM) Embolic Protection System in carotid stenting procedures. Data from the study will support a CE Mark application for use of the device during carotid stenting procedures. It also will support an IDE submission to the U.S. Food and Drug Administration (FDA) to begin a larger pivotal trial in the U.S. for the same indication. The U.S. pivotal trial is expected to commence during the summer of 2006.
The carotid pilot trial utilized 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 was studied and can be used in combination with any approved stent in the marketplace. Gary S. Roubin, M.D., Ph.D., Chairman, Department of Interventional Cardiology Lenox Hill Hospital, New York, NY, and Prof. Horst Sievert, M.D., CardioVascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany served as principal investigators for the study, which took place at 5 centers in the U.S. and Europe and enrolled 50 patients.
“The new TriActiv(R) ProGuard(TM) System raises the bar of what embolic protection should offer in carotid stenting,” commented Dr. Roubin as he narrated a carotid stenting case in which he used the TriActiv(R) ProGuard(TM) System as the embolic protection system at a recent conference. Dr. Roubin performed the case in front of a live audience at the Cardiovascular Revascularization Therapies Conference in March 2006, which highlighted new technologies and methods used in carotid stenting.
“We are very pleased with the early experiences of our device in the carotid anatomy,” said Joe Kaufmann, President and CEO of Kensey Nash Corporation. “During carotid stenting, it is imperative to provide the maximum protection against debris embolizing to the brain during the procedure. Competing filter devices, by design, cannot fully protect against microemboli, and for that reason we have confidence in our approach of balloon protection, flushing and automated extraction of any problematic debris,” he concluded.
Carotid artery disease is an additional target indication for the TriActiv(R) product offering that includes TriActiv(R), TriActiv FX(R), 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 FX(R) 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., which is pending at FDA. The TriActiv(R) ProGuard(TM) System has received CE mark in Europe for a saphenous vein graft indication.
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(R) 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(R) and TriActiv(R) ProGuard(TM) Systems, and has also launched the QuickCat(TM) Extraction Catheter as a new endovascular product. The ThromCat(TM) Thrombectomy System clearance is pending at FDA. 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(R) 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(R) System and other new endovascular products, the ability of Kensey Nash to successfully market the TriActiv(R) 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.
Kensey Nash Corporation
CONTACT: Joseph W. Kaufmann, President and CEO, Kensey Nash Corporation,+1-610-524-0188
Web site: http://www.kenseynash.com/
