Intact Vascular Will Accelerate Development of Tack Endovascular System

May 14, 2015—Intact Vascular, Inc. announced that it will be accelerating the development and pursuit of US Food and Drug Administration (FDA) approval for the company’s Tack Endovascular System with $38.9 million in a newly secured Series B venture capital financing. The company stated that it will use multiple clinical trials—both above and below the knee—to demonstrate the value of the Tack system in the treatment of peripheral artery disease (PAD) to support the FDA approval process.

According to Intact Vascular, the Tack Endovascular System is designed to optimize the results of percutaneous balloon angioplasty in PAD treatment. The device is designed to repair dissections in the artery wall that may occur as a complication of balloon angioplasty. It allows physicians to repair these dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options.

The Tack system is a 6-F multiloaded catheter containing four self-expanding tacks. The implant is 6 mm in length and has six pairs of anchors that optimize angioplasty by creating tissue apposition to smooth the arterial lumen. 

Intact Vascular was founded in 2012 to develop the technology pioneered by Peter Schneider, MD, who is Director of the Division of Vascular Therapy at the Kaiser Foundation Hospital in Honolulu, Hawaii. Bruce Shook serves as Intact Vascular’s President and Chief Executive Officer. The financing round was led by New Enterprise Associates, with participation from Quaker Partners, H.I.G. BioVentures, and other existing investors.

In April 2012, the company announced European CE Mark approval for the above-the-knee system. During the last 3 years, Intact Vascular has developed and refined the Tack Endovascular System implant and delivery system and conducted three international clinical trials that have enrolled more than 170 patients and demonstrated the promise of this new approach to arterial dissection repair. 

Earlier this year, 12-month results from the TOBA (Tack Optimized Balloon Angioplasty) clinical trial were presented by Coprincipal Investigator Marc Bosiers, MD, at LINC 2015: the Leipzig Interventional Course in Leipzig, Germany. Dr. Bosiers is Head of the Department of Vascular Surgery at AZ St. Blasius Hospital in Dendermonde, Belgium. Professor Dierk Scheinert, MD, from University Hospital Leipzig in Germany is also a Coprincipal Investigator of TOBA.

On April 29, the company announced the publication of 1-year follow-up results from the first-in-human safety and feasibility study demonstrating the potential for the Tack system to repair arterial dissections after percutaneous transluminal angioplasty. The article, “Early Experimental and Clinical Experience with a Focal Implant for Lower Extremity Post-Angioplasty Dissection,” was published by Dr. Schneider, et al in the Journal of the American College of Cardiology: Cardiovascular Interventions (2015;8:347–354).