MOUNTAIN VIEW, Calif., Sept. 30 /PRNewswire/ -- AccessClosure, Inc. today announced results from its MatrixVSG(TM) System Pivotal Trial. The trial enrolled 630 patients at 13 sites in the United States to evaluate the safety and efficacy of the synthetic hydrogel vascular closure technology designed to seal femoral artery punctures after interventional and diagnostic endovascular procedures. Patients were randomized 2:1 to standard compression, which is considered to be the gold standard for vascular closure.
Worldwide, over 12 million arterial punctures each year require closure and groin management following interventional or diagnostic endovascular procedures. However, broad acceptance of currently approved closure devices has been slow due to safety and efficacy concerns when compared to manual compression.
The Matrix VSG System has been developed by AccessClosure, Inc. to seal femoral arterial puncture sites after endovascular procedures through the simultaneous injection of two synthetic fluid components into the tissue tract of the access-site. Once the two fluids are delivered, they mix subcutaneously (within the tissue tract) to form a hydrogel sealant over the arterial access-site, around the artery and in the tissue tract. The fluids are comprised of fully synthetic and non-thrombogenic PolyEthylene-Glycol (PEG), a biomaterial commonly used in medical devices and pharmaceutical products. The PEG hydrogel is designed to be fully resorbable in the body in less than 30 days, leaving behind only a completely healed puncture-site. The material is designed so that if the PEG hydrogel is injected into the artery it will dissipate in flowing blood, thus minimizing catastrophic closure complications.
Final results from the Matrix(TM) VSG System trial were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) 16th Annual Scientific Symposium 2004 meeting in Washington DC by Mark A. Turco, M.D., Director of the Center for Cardiac and Vascular Research at Washington Adventist Hospital, Takoma Park, MD and Principal Investigator for the Matrix VSG(TM) Trial.
"We have successfully met the study safety and effectiveness endpoints demonstrating that this technology provides improved hemostasis and ambulation times with a safety profile non-inferior to standard compression, as per our study protocol," said Dr. Turco. "The times to hemostasis and ambulation were very impressive and thus support use of a hydrogel-based closure technology," continued Turco.
"The data that we are seeing today are consistent with data we've seen in our European clinical trials and we are excited to share the results," said Fred Khosravi, President & CEO of AccessClosure. "The successful completion of this study serves as a platform for AccessClosure to complete its Pre- Market Approval (PMA) application and also to bring forward a new pipeline of products for access-site management," continued Khosravi.
"What is different about this novel technology is that it provides secure and rapid extravascular closure with no animal by-products and bioresorbs within one month. All of these are recognized as important features for treating interventional and diagnostic patients who could benefit from the use of a closure device," added Turco.
AccessClosure expects final submission of the Pre-Market Approval (PMA) for Matrix VSG System to the US Food and Drug Administration in early fall, 2004.
AccessClosure is a privately-held company, based in Mountain View, CA and funded by ONSET Ventures and Three Arch Partners. The company is dedicated to developing next generation vascular access-site management technologies that address the unmet clinical need of safe, effective and simple groin management following interventional and diagnostic endovascular procedures.