Intact Vascular, Inc., a private medical device company committed to developing solutions for minimally invasive peripheral vascular procedures, today announced it received U.S. Food and Drug Administration (FDA) approval for the Tack Endovascular System (6F), a purpose-built dissection repair device implanted post-angioplasty in patients with peripheral arterial disease (PAD).
Regulatory approval was based on data from Intact Vascular's Tack Optimized Balloon Angioplasty II (TOBA II) pivotal trial, which demonstrated the safety and effectiveness of the Tack® implant to resolve dissections following angioplasty. Data from the pivotal trial were presented in a late-breaking scientific session at the 2018 VIVA conference.
"I look forward to having the Tack implant available for my patients," said Dr. William Gray, System Chief, Division of Cardiovascular Disease at Main Line Health, President, Lankenau Heart Institute and Principal Investigator for the TOBA II trial. "Post-angioplasty 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."
The inflation of an angioplasty balloon and resulting mechanical stress inherently injures vessels and creates dissections. These dissections are prevalent, underdiagnosed and underestimated. If left untreated, dissections can compromise clinical outcomes, resulting in acute thrombosis and arterial occlusions, leading to lower long-term patency rates and repeat procedures.
The TOBA II pivotal trial, notably the first peripheral vascular study to enroll patients with 100% dissected vessels, met all primary endpoints with 92% of dissections completely resolved following treatment. In this challenging patient population, the Tack® implant demonstrated 79.3% K-M vessel patency and 86.5% K-M freedom from clinically driven reintervention at 12 months, with only a 0.5% bailout stent rate and zero implant fractures.
"FDA approval of the Tack Endovascular System comes at a dynamic time in the PAD market place. The Tack system's unique combination of minimal metal and highly targeted dissection repair is an ideal fit with today's focus on minimizing inflammation and improving long term outcomes," stated Bruce Shook, President and CEO of Intact Vascular. He added, "Now with the Tack Endovascular System available in both Europe and the United States, we look forward to expanding our commercialization efforts and continuing to improve the quality of life for PAD patients."
Intact Vascular recently announced its European launch and first commercial cases in several centers across Germany. With FDA approval granted, the company plans a limited initial release in the US that will progress toward broader market commercialization.