06.10.14
Intact Vascular Inc. has appointed Joseph C. Griffin to the position of vice president of Regulatory Affairs and Quality Assurance.
“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,” Intact Vascular CEO Carol Burns said. “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., EU [European Union] and other international product approvals.”
Griffin most recently served as vice president of Regulatory Affairs at Flexible Stenting Solutions Inc., a subsidiary of Cordis Corporation. He 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 various 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 technology,” Griffin said in prepared remarks. “The 30-day Toba EU study data has me very excited about the prospect of gaining device approval here in the U.S.”
Intact Vascular is a privately held medical device company in Wayne, Pa., that develops minimally invasive peripheral vascular products. The Tack-It Endovascular System is designed to optimize peripheral balloon angioplasty results in the treatment of peripheral artery disease, a common circulatory problem in which narrowed arteries reduce blood flow to the body’s limbs.
“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,” Intact Vascular CEO Carol Burns said. “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., EU [European Union] and other international product approvals.”
Griffin most recently served as vice president of Regulatory Affairs at Flexible Stenting Solutions Inc., a subsidiary of Cordis Corporation. He 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 various 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 technology,” Griffin said in prepared remarks. “The 30-day Toba EU study data has me very excited about the prospect of gaining device approval here in the U.S.”
Intact Vascular is a privately held medical device company in Wayne, Pa., that develops minimally invasive peripheral vascular products. The Tack-It Endovascular System is designed to optimize peripheral balloon angioplasty results in the treatment of peripheral artery disease, a common circulatory problem in which narrowed arteries reduce blood flow to the body’s limbs.