Today Intact Vascular, Inc., reported that the Tack Optimized Balloon Angioplasty III (TOBA III) clinical trial has completed enrollment. A total of 200 patients have been enrolled in TOBA III at 14 sites in Europe.
The TOBA III study is a prospective, multi-center, single-arm study designed to investigate the safety and efficacy of the Tack Endovascular System® in combination with the Medtronic IN.PACT™ Admiral™ drug-coated balloon (DCB) in the treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries. The study includes a cohort of patients with long lesions, which are particularly challenging to treat successfully.
The company states the Tack Endovascular System® is a new solution for precision dissection repair following balloon angioplasty with a first-of-its-kind implant that is designed to help maintain vessel integrity and enhance blood flow to promote healing, improve outcomes and preserve limbs. Unrepaired dissections — which are frequent following balloon angioplasty — increase the probability of acute arterial occlusion and may continue narrowing the artery, which leads to lower long-term patency rates. The Tack Endovascular System leaves a minimal amount of metal in the artery, reduces mechanical stress on the arterial wall and preserves future treatment options.
Professor Dr. Marianne Brodmann, Head of the Clinical Division of Angiology, Medical University Graz, Austria on the study states, “Even in the era of drug-eluting technologies, post-angioplasty dissections continue to hinder long-term patency.” He adds, “I am encouraged that the Tack Endovascular System may provide durable, focal dissection repair using the least amount of metal and force in the artery.”
Bruce Shook, Intact Vascular’s President and CEO adds, “Our mission at Intact Vascular is to make all forms of angioplasty more effective and durable. TOBA III seeks to accomplish that goal with the Medtronic DCB and in particularly challenging lesions.” He concluded, “We want to thank our European investigators for their commitment to this important project and for completing study enrollment ahead of schedule.”
Intact Vascular is sponsoring two additional clinical trials to evaluate its Tack Endovascular System: TOBA II and TOBA II BTK. TOBA II is investigating the combination of the Tack device with both plain and drug-coated balloon angioplasty in the arteries above the knee, and completed enrollment in March 2017. TOBA II BTK is investigating the combination of the Tack device with plain balloon angioplasty in the arteries below the knee and is actively enrolling patients.