The US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint in Intact Vascular’s TOBA II BTK (Tack optimized balloon angioplasty II below the knee) clinical trial from 12 months to six months.
The TOBA II BTK study enrolled its first patient in February 2017 and is a prospective, multicentre, single-arm study designed to investigate the safety and efficacy of the Tack endovascular system in combination with standard balloon angioplasty in the popliteal and tibial arteries for the treatment of critical limb ischaemia (CLI). The Tack endovascular system is a new technology 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. 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.
“We are very pleased with FDA’s decision to approve our supplemental application to modify the primary endpoint to six months,” said Bruce Shook, Intact Vascular’s president and chief executive officer. “We believe that this will help accelerate the availability of the Tack endovascular system in the USA as an important new endovascular treatment for patients suffering from below-the-knee arterial disease.”
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. 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.