Data From the TOBA II Trial Presented for Intact's Tack Endovascular System
November 6, 2018—Intact Vascular, Inc. announced that the company's Tack Optimized Balloon Angioplasty II (TOBA II) clinical trial of the Tack endovascular system achieved both primary and secondary endpoints. Principal Investigator William Gray, MD, presented the 1-year results from the TOBA II study in the late-breaking scientific session at VIVA 2018, the Vascular Interventional Advances annual conference held November 5–8 in Las Vegas, Nevada.
The TOBA II study enrolled 213 patients with 100% dissected vessels at 33 sites in the United States and Europe to investigate the Tack device for the repair of postangioplasty dissections in femoropopliteal arteries. All patients in the study had 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.
According to the company, the results demonstrated 92.1% complete dissection resolution within a clinically challenging patient population, along with 79.3% Kaplan-Meier vessel patency and 86.5% Kaplan-Meier 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.
Dr. Gray commented in the company's announcement, “The TOBA II study is unique in that it is the first large-scale pivotal evaluation in peripheral arterial vessels that are 100% dissected following initial angioplasty and treated with a precisely targeted implant. This study introduces a new therapeutic paradigm, demonstrating that we can repair dissected arteries, leaving minimal metal behind to preserve future treatment options for our patients, and producing excellent 12-month outcomes.” Dr. Gray is System Chief, Division of Cardiovascular Diseases, and President, Lankenau Heart Institute at Main Line Health in Wynnewood, Pennsylvania.