APRIL 10, 2012 – WAYNE, Pa.–(BUSINESS WIRE)- Intact Vascular, a medical device company and developer of products for minimally invasive peripheral vascular procedures, today announced its European notified body has granted the company ISO Certification and CE Mark approval for Tack-It Endovascular System™ device. The stapling device is designed to optimize peripheral angioplasty results for the treatment of peripheral artery disease (PAD). Peripheral artery disease of the lower extremities affects more than 8 million people each year, with approximately 20% of those requiring treatment.
Balloon angioplasty is the most commonly performed peripheral intervention used to improve blood flow in leg arteries. However, suboptimal results occur frequently due to an irregularly shaped lumen or tissue dissection from the angioplasty mechanism itself. If left untreated, acute or long-term complications can occur resulting in a re-intervention, tissue loss, or amputation. The Tack-It Endovascular System™ device is a 6F multi-loaded catheter containing four self-expanding tacks. The 6.0mm-length implant has six pairs of anchors designed to optimize angioplasty by creating tissue apposition to smooth the arterial lumen.
“This is a significant milestone for the company, as we are one step closer to providing this technology for patients in which peripheral artery disease procedures are growing at double-digit rates partly due to the staggering rise in patients with Type 2 diabetes,” said Intact Vascular CEO Carol A. Burns of the CE Mark approval. “This is a unique solution for patients, offering physicians a new paradigm for treatment. Three important concepts are at the core of Co-Founder, Robert Giasolli’s design, which includes: 1) less foreign material in the artery, 2) less long term chronic injury to the vessel, and 3) the ability to perform ‘spot’ treatment to the vessel only where needed.”
Co-Founder and Chief Medical Officer, Peter Schneider, M.D., states, “Right now, we are very limited by the tools we have available. We can either do angioplasty, which often produces a suboptimal result, or we can place a stent, which looks good initially but often does not last and has a lot of downstream problems. We believe the Tack technology will offer a new solution to address this problem. One of the key design features is that the device can treat a range of diameters offering tremendous versatility. This will enable physicians to go down the leg after angioplasty and spot-treat several areas using a single device.”
A clinical trial was conducted in South America on 11 subjects in whom 50 Tacks were placed. The subjects were followed for 12 months.
“This is a First-in-Man experience with a novel approach to SFA revascularization,” stated William A. Gray, M.D., who serves as an advisor to the company. “The one-year results are very encouraging, and the company is planning to initiate a post-CE Mark clinical study within the next couple of months.”
About Intact Vascular
Intact Vascular is a privately held medical device company 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. This technology will offer physicians a new treatment option for treating peripheral artery disease. Intact Vascular is committed to developing safe and efficacious products for patients and for the physicians who use these products. Visit www.intactvascular.com for more information.