FDA Approves 6-Month Primary Endpoint for Intact Vascular's TOBA II BTK Trial


July 10, 2017—Intact Vascular announced that the US Food and Drug Administration (FDA) approved an investigational device exemption supplemental application to modify the primary endpoint in the Tack Optimized Balloon Angioplasty II Below-the-Knee (TOBA II BTK) clinical trial from 12 months to 6 months.

The TOBA II BTK pivotal clinical trial was approved by the FDA to investigate the company's permanent vascular implant in arteries below the knee. The prospective, multicenter, single-arm study is designed to evaluate the safety and efficacy of Intact Vascular's Tack endovascular system in combination with standard balloon angioplasty in the popliteal and tibial arteries for the treatment of critical limb ischemia. Study enrollment began in February 2017.

According to the company, the Tack endovascular system is designed to repair dissections in the artery wall that frequently occur as a complication of balloon angioplasty. The system is intended to provide physicians with an alternative for repair of dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options.

Intact Vascular is sponsoring three clinical trials to evaluate the 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. TOBA II BTK is investigating the combination of the Tack device with plain balloon angioplasty in the arteries below the knee. TOBA III is currently underway in Europe and is investigating the combination of the Tack endovascular system with drug-coated balloon angioplasty.

The Tack device has received CE Mark approval in Europe but is not available for sale or commercial use in the United States, where it is limited by federal law to investigational use, advised the company.


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