Kensey Nash has commenced enrolment of a 300 to 400 patient pivotal study for its TriActiv ProGuard Embolic Protection System (EPS) in carotid stenting procedures. If successful, the PROGUARD trial will support a 510(k) submission, currently anticipated in early 2008 following the expected completion of enrolment.
The TriActiv ProGuard EPS is the company's newest version of the TriActiv System product line, which incorporates Local Flush and eXtraction (LFX) technology designed for use in branched arteries, such as those of the carotid blood vessels. The TriActiv ProGuard EPS 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 studied and can be used in combination with any approved stent in the marketplace.
Dr Gary S Roubin, Chairman, Department of Interventional Cardiology, Lenox Hill Hospital, NY, and Dr Rajesh Dave, Chairman, Endovascular Medicine, Pinnacle Health Heart and Vascular Institute, Harrisburg, PA, will serve as co-principal investigators for the study, which will take place at up to 35 US sites and five European sites.
The primary outcomes are composite of major adverse events including any death, any stroke and/or myocardial infarction through thirty days post-procedure. The secondary outcomes include the rate of subject intolerance to prolonged carotid artery occlusion; rate of access site complications requiring treatment with blood transfusion or surgical repair; rate of successful use of the study device success; rate of successful lesion treatment; and the rate of procedure success.
"Practitioners continue to need better solutions to prevent debris from reaching the brain during carotid stenting," commented Roubin. "We believe that the TriActiv ProGuard System offers some significant benefits, and so we are looking forward to studying this device in a large comprehensive study. I have been impressed with the ease of use and short occlusion times of Kensey Nash's balloon protection system. These attributes of the device are compelling," he added.
Earlier this year, Kensey Nash completed a pilot trial to study the safety of the TriActiv ProGuard device in carotid patients at five sites in the US and Europe. The data showed no incidence of major strokes or death in the 50 patient study. That data is supporting a CE mark application, currently pending, which would allow use of the device during carotid stenting procedures in Europe.
Dave, who performed the first US cases of the PROGUARD trial, said, "As carotid stenting continues to be adopted, the effectiveness of embolic protection systems to prevent major adverse events is paramount. The data from the TriActiv ProGuard pilot trial suggests that balloon protection in combination with the gentle flushing and automated extraction is a promising solution," he concluded.
Carotid artery disease is an additional target indication for the TriActiv product offering that includes TriActiv FX and the new investigational TriActiv ProGuard Systems. 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 FX 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.
Date: Feb/2007
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