Intact Vascular said today it won FDA Investigative Device Exemption for a clinical trial of its Tack endovascular system for patients with peripheral arterial disease undergoing percutaneous angioplasty.
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, Wayne, Penn.-based Intact Vascular said.
“The earlier Toba experience demonstrates that the long term results from angioplasty can be substantially improved if we repair arterial dissections using this new approach to minimize vessel trauma while leaving as little metal behind as possible. The Tack implant supports the dissection and allows the vessel to heal, while preserving future treatment options for patients. I am very excited that the Toba II trial will allow us to study this technology in combination with both standard and drug-coated angioplasty balloons – a 1st of its kind study design. No other vascular implants have been methodically studied following vessel treatment with a drug-coated balloon,” principal investigator Dr. William Gray of Columbia University Hospital said in prepared remarks.
The Toba II trial is slated to enroll 210 patients at 30-40 sites across the U.S. and Europe, the company said, and the 1st patients in the trial have already been enrolled at the Yuma Regional Medical Center, the company said.
“This new approach of spot treating dissections supports our desire to leave as little metal behind as possible. The Tack implant is also uniquely designed to adapt to the diameter of the vessel in which it is implanted, unlike stents, which have to be specifically sized to the vessel. This makes the procedure fast, flexible and user-friendly for the hospital staff and the operator to efficiently treat our patients,” Dr. Joseph Cardenas of the Yuma Regional Medical Center said in a prepared statement.
Patients in the study will be treated with the company’s Tack endovascular system following a standard balloon or drug-coated balloon angioplasty in the superficial femoral and proximal popliteal arteries in cases where a dissection, or tear in the artery wall, occurs, the company said.
“We are thrilled by the enthusiasm and responsiveness of our clinical investigators, particularly Dr. Cardenas and his team at Yuma. The rapid commencement of this trial highlights the clinical need for a better method to repair arterial dissections and the keen interest clinicians have shown in a minimal metal solution to this growing problem,” CEO Bruce Shook said in a press release.