Enrollment Begins in European TOBA Study of Intact Vascular's Tack-It Stapler

September 5, 2012—Intact Vascular, Inc. (Wayne, PA) announced that it has commenced enrollment in the European TOBA (Tack Optimized Balloon Angioplasty) study of the company's Tack-It endovascular stapler system, which received CE Mark approval earlier this year. The Tack-It endovascular stapling device is designed to optimize peripheral angioplasty results for the treatment of peripheral artery disease.

According to Intact Vascular, the TOBA clinical study is evaluating the Tack-It stapler for use in the superficial femoral and popliteal arteries after angioplasty. The study is a multicenter, prospective trial that will enroll up to 138 patients.

The Tack-It endovascular stapler system is a 6-F multiloaded catheter containing several self-expanding tacks. The 6-mm-length implant has six pairs of anchors, creating tissue apposition to smooth the arterial lumen. The device is designed to leave less foreign material in the artery, cause less long-term chronic injury to the vessel, and allow spot treatment only where needed, advised the company.

Intact Vascular also announced that it has secured $15.5 million of Series A financing to support the completion of the trial and to support further development of a 4-F Tack-It system to be used in arteries below the knee.

With the close of this financing, Dennis Wahr, MD, has been appointed Chairman of the Board of Directors of Intact Vascular. Dr. Wahr is the former Chief Executive Officer of Lutonix, Inc. (Maple Grove, MN), which was recently acquired by CR Bard, Inc. (Murray Hill, NJ). Peter A. Schneider, MD, is the Cofounder and Chief Medical Officer of Intact Vascular.

Dr. Schneider commented, “We need to improve the results of balloon angioplasty, but right now all we can do is stent. It is just too much metal, too much stiffening of the artery, and it is associated with too many downstream problems, like restenosis and fracture. We believe the Tack-It technology will offer a new solution to address this problem.”