Cardiology
FDA Gives Clearance to the Latest Embolic Protection System
By Akanksha, Pharmacology Correspondent
Mar 25, 2005, 08:50

Kensey Nash Corporation today announced it has received FDA clearance for its TriActiv� System, allowing sale of the product in the United States. The Company will launch the product through its new direct sales force.

"This is an historic event for our company," stated Joe Kaufmann, President and CEO of Kensey Nash Corporation. "The embolic protection market has emerged as one that is critical to patient care, and we believe the embolic protection device will offer important new benefits to the physicians and their patients," he commented. "We believe that the imminent launch of the embolic protection device with our own sales team will transform our company by allowing us to better leverage our strong cardiology technology base," Mr. Kaufmann continued his comments. "With the focus of a dedicated sales force, we will endeavor to bring the best solutions directly to interventional cardiologists in a quick and focused manner. As the embolic protection market evolves and grows, we expect this customer interface to be extremely beneficial to the growth of our company. It is our goal to expand indications and introduce new versions of the embolic protection device technology to the medical community over the next several years," he concluded.

"Physicians will benefit from the use of this device in their practices," said Joseph Carrozza, MD of Beth Israel Hospital, Boston, Massachusetts, the principal investigator of the PRIDE trial. "We were very pleased to see how well the embolic protection device performed in a very challenging patient population during the PRIDE trial, and it is gratifying to see that the technology will now be available to treat the general saphenous vein graft population. This new system has important advantages for physicians and patients, and should help advance clinical practice towards more universal usage of embolic protection for all SVG patients."

"I am very eager to incorporate the embolic protection device into my practice," said Chris Metzger, MD of Holston Valley Medical Center, Kingsport, Tennessee, the leading enroller of patients in the PRIDE trial that supported the FDA clearance. "The embolic protection device has proven to be an easy-to-use tool that effectively prevents embolic debris from causing MACE (Major Adverse Cardiac Events) in patients undergoing saphenous vein graft interventions. Prevention of MACE is essential for patient health and for cost savings in the healthcare system. This system gives me greater confidence that I have completely protected the vessel and actively removed embolic debris."

The FDA clearance was based on an 894-patient clinical study of the safety and effectiveness of the embolic protection device. The PRIDE trial (PRotection during saphenous vein graft Intervention to prevent Distal Embolization) achieved its objective of showing non-inferiority of the said System to other commercially available devices.

The results demonstrated that the said System had equivalent clinical outcomes to the control group consisting of two previously approved embolic protection systems. The rate of MACE at 30 days, the primary endpoint of the trial, was 9.8% for the approved the said embolic protection device, compared to 9.7% for the control group. MACE rates often run as high as 20% in vein graft procedures performed without embolic protection systems.

Kensey Nash has established a dedicated sales force to sell the embolic protection device in the United States. The Company now has an initial twelve-person team in place, complementing the existing clinical staff which supported the product through the clinical trials.

The TriActiv� System is an embolic protection device used during percutaneous coronary intervention of diseased saphenous vein grafts.

The system prevents material or debris, dislodged during stent procedures, from embolizing downstream and causing adverse coronary events such as a heart attack. 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 treated vessel.

Saphenous vein graft disease is the initial target indication for the embolic protection device in the U.S. Each year, there are approximately 550,000 coronary artery bypass surgeries performed worldwide as treatment for coronary artery disease.

Saphenous vein grafts, commonly used in cardiac bypass surgery, tend to become blocked within 10 years of the original surgery and pose one of the more challenging problems facing interventional cardiologists and cardiac surgeons today.

Current sales for embolic protection systems used during SVG procedures are estimated to approximate $100 million worldwide and are expected to grow substantially over the next several years as next- generation products are developed and as indications are expanded. The carotid stenting market, for example, is a future target market for the said System.

The Device is currently approved for sale for the saphenous vein graft indication in the European Union. Kensey Nash is selling direct to customers in Germany and through distributors in other countries. Kensey Nash is working to extend the embolic protection device platform to ultimately address all vessels where embolic protection is important for patient safety.

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