Intact Vascular's TOBA III Trial Completes Enrollment in Europe

May 3, 2018—Intact Vascular, Inc. announced that its 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 prospective, multicenter, single-arm TOBA III study is designed to investigate the safety and efficacy of the company's Tack endovascular system in combination with the In.Pact Admiral drug-coated balloon (Medtronic) for the treatment of peripheral artery disease in the superficial femoral and popliteal arteries. The study includes a cohort of patients with long lesions, which are particularly challenging to treat successfully.

According to the company, the Tack endovascular system is used for precision dissection repair after balloon angioplasty. The system's implant helps maintain vessel integrity and enhance blood flow to promote healing, improve outcomes, and preserve limbs. Additionally, the device leaves a minimal amount of metal in the artery, reduces mechanical stress on the arterial wall, and preserves future treatment options.

Professor Marianne Brodmann, MD, who serves as Principal Investigator of TOBA III, commented in the company's announcement, “Even in the era of drug-eluting technologies, postangioplasty dissections continue to hinder long-term patency. 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.” Prof. Brodmann is Head of the Clinical Division of Angiology, Medical University Graz, Austria.