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Intact Vascular reports the TOBA II BTK is a prospective, multi-center, single-arm study designed to investigate the safety and efficacy of the Tack Endovascular System in combination with standard balloon angioplasty in the mid/distal popliteal, tibial and peroneal arteries during the treatment of critical limb ischemia (CLI) patients. The Tack implant is a first-of-its kind device for precision dissection repair following balloon angioplasty. The system is designed to help maintain vessel integrity and improve blood flow to promote healing, improve outcomes and preserve limbs. The system leaves a minimal amount of metal in the artery, reduces mechanical stress on the arterial wall and preserves future treatment options. 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. TOBA II BTK is the first known industry sponsored pivotal clinical trial approved by the US Food and Drug Administration to investigate a permanent vascular implant in arteries below the knee.
Bruce Shook, Intact Vascular’s President and CEO commented: “We are very pleased to be making excellent progress in this important study as we exceeded the 100th patient milestone.” Shook concluded, “We are on track to complete enrollment earlier than originally planned, and we are thankful to our committed investigators who are eager to have more approved therapeutic options to treat their patients with CLI.”
Intact Vascular is sponsoring three clinical trials to evaluate its Tack Endovascular System: TOBA II, TOBA II BTK and TOBA III. 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 February 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. TOBA III has nearly completed enrollment in Europe and is investigating the combination of the Tack device with drug-coated balloon angioplasty, inclusive of long lesions. More information can be found here.