Intact Vascular today announced the European launch of the Toba II BTK clinical trial of its Tack endovascular system in combination with standard balloon angioplasty in the popliteal and tibial arteries for treating critical limb ischemia.
The 1st European patient in the trial was enrolled by Dr. Marianne Brodmann and Dr. Peter Reif at Austria’s Medical University Graz, the Wayne, Penn.-based company said.
“We are pleased to be the 1st center in Europe to commence enrollment in Toba II BTK. I believe the Tack endovascular system is a very promising technology designed to optimize dissection repair while leaving a minimal metal footprint behind post-implantation,” Dr. Brodmann said in a prepared statement.
“The spiral dissection we treated in this 1st patient was ideally suited for the Tack endovascular system since it is the only device uniquely designed to treat below-the-knee dissections following angioplasty,” Dr. Rief said in a prepared release.
The Tack endovascular system is designed to repair dissections that occur as a complication of balloon angioplasty. The system allows operating physicians to repair dissections with only a small amount of foreign material in the artery, Intact Vascular said.
The prospective, multi-center, single-arm Toba II BTK study enrolled its 1st patient in February this year, and aims to investigate the safety and efficacy of the combined therapy from its Tack system and standard balloon angioplasty in arteries below the knee.
The company touted the trial as the 1st industry sponsored pivotal clinical trial approved by the FDA to investigate a permanent vascular implant in arteries below the knee. The study is slated to enroll 232 patients at 50 global sites.
“Critical limb ischemia is a serious disease that all too often leads to amputation. It is vital that we develop new technologies to restore and maintain blood flow to the lower leg and foot. I am pleased that we have commenced enrolling patients in European centers. The Tack endovascular system represents a major step forward in the endovascular treatment of CLI,” study principal investigator Dr. Andrej Schmidt of the University Hospital Leipzig said in a press release.
Last week, Intact Vascular said the FDA approved an investigational device exemption supplemental application to modify the primary endpoint in the trial from 12 months to 6 months.