One-year results from Intact Vascular’s Tack Optimized Balloon Angioplasty II (TOBA II) successfully achieved both its primary and secondary endpoints. The Wayne, PA-based company announced the results at the 15th annual VIVA conference in Las Vegas.
The company said this is the first peripheral vascular study to enroll patients with 100% dissected vessels, the TOBA II study, was conducted at 33 U.S. and European sites to investigate the Tack Endovascular System for the repair of post-angioplasty dissections in femoropopliteal arteries. All patients enrolled (n=213) suffered from peripheral arterial disease (PAD), underwent balloon angioplasty with either plain or drug-coated balloons, and consequently experienced at least one dissection, with 69.4% being classified as severe.
Results thE study demonstrated 92.1% complete dissection resolution within a clinically challenging patient population, along with 79.3% K-M vessel patency and 86.5% K-M freedom from clinically driven reintervention at 12-months. Additionally, the TOBA II study validated the Tack implants as stable and durable, with zero implant fractures, 99.9% freedom from migration, and a 0.5% bailout stent rate.
The Tack Endovascular System is an implant for the precision dissection repair following balloon angioplasty and received CE mark in 2012. The device is designed to help maintain vessel integrity and improve blood flow to promote healing, improve outcomes and preserve limbs.
“The TOBA II data further augment the growing body of evidence supporting the idea that a purpose-built implant for dissection repair can enhance the clinical results of balloon angioplasty,” Bruce Shook, Intact Vascular’s president and CEO said in a release. “The Tack Endovascular System is also well aligned with a primary goal of endovascular operators: to leave as little metal behind as possible.”
In March, Intact Vascular executives spoke with MD+DI about plans for the Tack Endovascular System and when the implant could possibly hit the U.S. market.