Intact Vascular said that the regulatory approval was based on data from the pivotal trial – Tack Optimized Balloon Angioplasty II (TOBA II) it has conducted.

The trial showed the safety and effectiveness of the Tack implant to resolve dissections following angioplasty and the data from pivotal trial were presented in a scientific session at the 2018 VIVA conference.

TOBA II trial principal investigator William Gray said: “I look forward to having the Tack implant available for my patients. 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 company said that the inflation of an angioplasty balloon results in mechanical stress that inherently injures vessels and creates dissections, which are prevalent, underdiagnosed and underestimated.

If the dissections are left untreated, they may compromise clinical outcomes and result in acute thrombosis and arterial occlusions, leading to lower long-term patency rates and repeat procedures.

Intact Vascular claims that its TOBA II pivotal trial marks the first peripheral vascular study to enroll patients with 100% dissected vessels and satisfied all the primary endpoints with 92% of dissections completely resolved following treatment.

In addition, the Tack implant has demonstrated 79.3% K-M vessel patency and 86.5% K-M freedom from clinically driven re-intervention at 12 months, with only a 0.5% bailout stent rate and zero implant fractures.

Intact Vascular president and CEO Bruce Shook said: “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.

“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.”

Following the FDA approval, the company said that it is planning for a limited initial release in the US expecting its progress toward broader market commercialization.