Innovation That Touches People's Lives

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European Cardiovascular Disease 2006 - Issue 1;2006:2(1):1-2

Kensey Nash Corporation is a medical device company known for its innovative product development and unique technology in the fields of endovascular devices and resorbable biomaterials. Since its founding in 1984, the company has focused on developing unique solutions to complex medical problems. As the inventor and developer of the Angio-Seal™ Vascular Closure Device, Kensey Nash pioneered the concept of arterial closure. Currently, the Angio-Seal device (manufactured, marketed and sold by the licensee St. Jude Medical) is the leading arterial puncture closure product in the world, with over six million Angio-Seal units sold since its market introduction.

Recently, the company has focused on commercialising its TriActiv┬« System platform, a novel group of embolic protection products designed to prevent debris from travelling downstream (distal embolisation) from the treatment site during stenting procedures. Embolic debris is closely associated with the adverse events of heart attack and stroke in patients undergoing certain types of intervention procedures. The TriActiv System incorporates three features to address the common problem of distal embolisation: a balloon protection guidewire, a flush catheter, and an extraction system to remove debris found in the treated vessels. These features are designed to work in concert to remove debris from the patientÔÇÖs vessel, and prevent potential complications such as heart attack or stroke. The device is intended to provide the interventional cardiologist with a comprehensive solution for capturing and removing dislodged embolic material.

Kensey Nash launched its first TriActiv System product in the US in March 2005. The next generation of the device, the TriActiv FX┬« System, is expected to launch in the Spring 2006 in the US (pending US Food and Drug Administration (FDA) clearance) following compelling results of the Angioplasty in SVGs with Post Intervention Removal of Embolic Debris (ASPIRE) study. A third version of the device, the TriActiv ProGuard™ is being studied for its usefulness in conjunction with carotid stenting, a new therapy designed to prevent people from having strokes. The ProGuard System incorporates Local Flush and eXtraction technology (LFX™), a design enhancement to make it suitable for branched anatomy. The TriActiv FX System (7Fr.) and TriActiv ProGuard System (6Fr.) are available for sale in Europe with a saphenous vein graft (SVG) indication.

Treatment of SVG disease is the initial indication for the TriActiv System. Each year, there are approximately 500,000 coronary artery bypass grafts (CABGs) performed worldwide to treat coronary artery disease, and many surgeries use a saphenous vein as the bypass vessel. When the SVGs become diseased over time and need to be opened, they tend to represent extremely challenging cases for doctors with resultant high adverse event rates. Recently, clinical trials have shown the effectiveness of embolic protection devices to significantly reduce such adverse event rates during SVG interventions, and hence, most key thought-leaders advocate the universal use of embolic protection during SVG intervention. Kensey Nash estimates this initial market opportunity for its TriActiv System to be approximately US$250 million, with the ultimate market opportunity for embolic protection and extraction technologies estimated to be approximately US$1 billion.

Kensey Nash has completed the FDA 510(k) and CE mark submissions for the Thrombectomy System, ThromCat™ - a novel technology that combines flushing, maceration and extraction to easily and reliably remove thrombi. Clearance is anticipated in the near future.

Kensey Nash Corporation has a broad portfolio of biomaterial products to assist medical device partners with the development and manufacturing of products for orthopaedics, sports medicine, drug delivery and surgical applications. Each year, Kensey Nash manufactures and sells over three million resorbable product units, representing over 100 commercialised products, primarily to business partners and customers, many of whom are leaders in their sectors. The company continues to expand its business through offering its significant expertise and intellectual property, in this arena, to a growing customer base interested in commercialising novel biomaterials-based products. Ôûá