April 9, 2012
Intact Vascular's Tack-it Endovascular Stapler Receives CE Mark Approval
April 10, 2012—Intact Vascular (Wayne, PA) announced that it has received CE Mark approval for its Tack-it endovascular stapler. The stapling device is designed to optimize peripheral angioplasty results in the treatment of peripheral artery disease. The Tack-it device is a 6-F multiloaded catheter containing four self-expanding tacks. The 6-mm-length implant has six pairs of anchors designed to optimize angioplasty by creating tissue apposition to smooth the arterial lumen.
Regarding current endovascular treatments of peripheral artery disease, Intact Vascular's Co-Founder and Chief Medical Officer Peter Schneider, MD, observed, "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."
Dr. Schneider added, "We believe the Tack-It 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."
The company advised that a clinical trial with 12-month follow-up was conducted in South America and included 11 patients in whom 50 tacks were placed.
“This is a first-in-man experience with a novel approach to superficial femoral artery revascularization,” stated William A. Gray, MD. “The 1-year results are very encouraging, and the company is planning to initiate a post-CE Mark clinical study within the next couple of months.”