TOBA II BTK Trial Enrollment Ahead of Schedule for the Tack Endovascular System® in Below the Knee Disease

WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial surpassed the 100 patient milestone, advancing enrollment well ahead of schedule.

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.

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