Intact Vascular Inc. has appointed Joseph C. Griffin to the position of vice president of regulatory affairs and quality assurance.
The Wayne, Pa.-based company is privately held and develops minimally invasive peripheral vascular products. The company's Tack-It endovascular system is designed to optimize peripheral balloon angioplasty results in the treatment of peripheral artery disease (PAD). This technology will offer physicians a new treatment option for treating PAD which affects 8-12 million in the United States.
“This year our focus is on obtaining FDA (U.S. Food and Drug Administration) IDE (investigational device exemption) approval for our U.S. clinical trial for the Tack-It endovascular system," said CEO Carol Burns. "This is an opportune time to bring in someone of Joe’s caliber to lead this effort. He brings a wealth of medical device knowledge to the company along with a successful track record of gaining U.S., E.U. and other international product approvals.”
Most recently, Griffin served as vice president of regulatory affairs at Flexible Stenting Solutions Inc., a subsidiary of Johnson & Johnson's Cordis Corporation Griffin joined Flexible Stenting Solutions in March 2008 as a vice president and executed various regulatory, quality, clinical and compliance duties leading up to a Cordis acquisition in March 2013. Griffin has more than 30 years of experience in design, development, regulatory compliance and manufacture of cardiovascular devices.
“I’m enthusiastic about the potential for the Tack-It device to offer a new paradigm in the treatment of peripheral artery disease for both above and below the knee procedures, and look forward to contributing to the ultimate goal of FDA approval of this novel technology." Griffin said. "The compelling 30-day TOBA EU study data presented at the recent LINC meeting has me very excited about the prospect of gaining device approval here in the U.S.”