EXTON, Pa., April 10 /PRNewswire-FirstCall/ -- Kensey Nash Corporation (Nasdaq: KNSY - News) today announced it has received CE Mark approval to expand the indication for the third generation of its embolic protection technology, known as the TriActiv® ProGuard(TM) System, for use in the carotid anatomy. This is an important new indication for the Kensey Nash device in the European marketplace, because the use of embolic protection devices is very prominent in carotid stenting procedures. The Company had launched the TriActiv® ProGuard(TM) System in Europe for use in saphenous vein graft procedures last year.
The TriActiv® ProGuard(TM) System is the Company’s newest version of the TriActiv® System product line, which incorporates Local Flush and eXtraction (LFX(TM)) technology designed for use in branched anatomy, such as those of the carotid arteries. The TriActiv® 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 has been clinically studied and can be used in combination with any approved carotid stent in the marketplace.
To support the CE Mark, Kensey Nash had completed a pilot trial to study the safety of the TriActiv® ProGuard(TM) device in carotid patients at 5 sites in the U.S. and Europe. The data showed no incidence of major strokes or death in the 50 patient study. Kensey Nash is also currently enrolling patients in the PROGUARD Carotid Pivotal Study, a 300-400 patient registry, the results of which are intended to support FDA clearance.
“The TriActiv® ProGuard(TM) platform was designed with the carotid market in mind, and so this regulatory approval is a significant milestone for this product line,” commented Joe Kaufmann, President and CEO of Kensey Nash Corporation. “Most physicians consider embolic protection an inherent part of carotid stenting, and we are pleased to be able to offer our customers a new balloon protection alternative. The attributes of gentle flushing and automated extraction are features that we believe contribute to the efficacy of our approach. We are looking forward to launching the product this quarter,” he concluded.
Carotid artery disease is the newest indication for the TriActiv® product line offering. Kensey Nash estimates that approximately 50,000 carotid artery stenting procedures are currently being performed worldwide each year, a small percentage of the over 500,000 people who suffer from carotid artery disease. Many people continue to be treated with a highly invasive surgical endarterectomy procedure and many others go untreated due to the invasiveness of the surgical procedure alternative. With the advent of carotid stenting in combination with embolic protection devices continuing to show promising results, Kensey Nash believes that carotid stenting will become the standard of care for the treatment of carotid artery disease. This trend has recently been bolstered in the U.S. with proposed changes to reimbursement policies, which, if implemented, would expand national coverage of carotid stenting procedures.
The TriActiv® ProGuard(TM) System is a protection system designed to prevent material or debris, dislodged during stent procedures, from embolizing and causing adverse events such as a heart attack or stroke. This is accomplished with three integrated system features: an embolic protection balloon, and a combined active flush and extraction system to remove the problematic debris from the target vessel. The TriActiv® System is the only distal embolic protection system that actively removes the debris from the vessel by gently flushing the treatment area within the vessel.
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 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 Corporation
