FDA Approves Intact Vascular’s Tack Endovascular System
April 15, 2019—Intact Vascular, Inc. announced FDA approval for the 6-F Tack endovascular system, a dissection repair device implanted after percutaneous transluminal angioplasty (PTA) in patients with peripheral artery disease (PAD). The company plans for a limited initial release in the United States that will progress toward broader market commercialization.
According to the company, the Tack device is preloaded with six self-expanding nitinol implants for above-the-knee interventions. It can be deployed to treat multiple dissections using a single catheter, leaving behind > 70% less metal than stents. Additionally, it is designed to minimize vessel inflammation, promote healing, improve outcomes, and preserve future treatment options for patients with PAD.
Intact Vascular recently announced the European launch and first commercial cases in several centers in Germany. The Tack device first received European CE Mark approval for the repair of arterial dissections after PTA above the knee. In January 2017, the company announced CE Mark approval for the repair of arterial dissections after PTA below the knee.
The company advised that FDA approval was based on data from Intact Vascular's TOBA II pivotal trial, which demonstrated the safety and effectiveness of the Tack implant to resolve dissections after angioplasty. Data from TOBA II were presented by Principal Investigator William Gray, MD, in a late-breaking scientific session at VIVA 2018, the Vascular Interventional Advances annual conference held November 5–8 in Las Vegas, Nevada. Dr. Gray is System Chief, Division of Cardiovascular Disease, at Main Line Health and President of Lankenau Heart Institute in Wynnewood, Pennsylvania.
All primary endpoints in TOBA II were achieved, with 92% of dissections completely resolved after treatment. Additionally, the Tack implant demonstrated 79.3% vessel patency and 86.5% freedom from clinically driven reintervention at 12 months (by Kaplan-Meier estimate), with a 0.5% bailout stent rate and zero implant fractures.
Dr. Gray commented in the company's announcement, “I look forward to having the Tack implant available for my patients. Postangioplasty dissections can significantly impact patient outcomes. Having a minimal metal solution that specifically addresses dissections and improves angioplasty results while preserving future treatment options is extremely exciting.”