First-in-Human Data Show Promise for Intact Vascular's Tack System

April 29, 2015—Intact Vascular, Inc. announced that 1-year follow-up results from the first-in-human (FIH) safety and feasibility study demonstrate the potential for the company’s Tack endovascular system to repair arterial dissections after percutaneous transluminal angioplasty (PTA). Peter A. Schneider, MD, et al published “Early Experimental and Clinical Experience with a Focal Implant for Lower Extremity Post-Angioplasty Dissection” earlier this year in the Journal of the American College of Cardiology: Cardiovascular Interventions (2015;8:347–354).

According to Intact Vascular, the FIH study was conducted at two sites in Asunción, Paraguay: Santa Clara Hospital and The Italian Hospital. Eleven patients with 15 treated ischemic limbs were enrolled. The 25 treated lesions included 8 in the superficial femoral artery (SFA), 7 in the popliteal artery, and 10 in the tibial artery. Six of the lesions were occlusions and 19 were stenoses. An average of 3.4 Tacks were implanted per patient. Successful dissection repair was achieved at all the lesion sites with the placement of the Tack implant, as determined by angiography. 

The key endpoints at 12-month follow-up included 100% repair of dissection flaps and patency rates of 87.5% for SFA and popliteal vessels; 83.3% for SFA, popliteal, and tibial vessels; and 80% for tibial vessels only. Additionally, there was no limb loss, no implant migration, and one target lesion revascularization. There was one death, which was not related to the device or procedure.

In the company’s press release, Dr. Schneider said, “This early clinical experience highlights the potential for a new paradigm in treating peripheral arterial disease that minimizes the metal we leave behind, helps heal the trauma associated with angioplasty, and preserves future treatment options for patients.” Dr. Schneider is a vascular surgeon at Kaiser Hospital in Honolulu, Hawaii, and serves as Chief Medical Officer of Intact Vascular. 

Dr. Schneider added, “The medical community has been looking for treatment options that reduce vessel inflammation and, ultimately, reocclusion. The recent introduction of drug-coated balloons advances the basic angioplasty procedure toward that goal, and the Tack endovascular system will work to solve the problem of repairing arterial dissections with minimal inflammation. These innovations, taken together, represent the next generation of treatment options for our patients.”

The company noted that these early findings join the 12-month European TOBA (Tack Optimized Balloon Angioplasty) clinical trial to make a strong foundation for the development of the device. The TOBA trial was presented in January at LINC 2015: the Leipzig Interventional Course in Leipzig, Germany. 

The Tack endovascular delivery catheter contains multiple self-expanding nitinol Tacks to minimize exchanges and increase procedural efficiency. The device is designed to optimize angioplasty by repairing vessel wall dissections, while allowing the artery to maintain its natural configuration. According to Intact Vascular, the Tack endovascular system has been designed to leave minimal foreign material in the artery, apply a low outward force on the arterial wall, and allow “spot” treatment only where needed.