Intact Vascular Receives Conditional FDA Approval for TOBA II Study of Tack System
September 30, 2015—Intact Vascular, Inc. announced that the US Food and Drug Administration has granted conditional approval for a United States and European investigational device exemption clinical trial, Tack Optimized Balloon Angioplasty II (TOBA II). TOBA II will investigate use of the company’s Tack endovascular system as a dissection repair therapy in patients with peripheral artery disease undergoing percutaneous angioplasty.
According to Intact Vascular, the TOBA II study will be composed of 210 patients experiencing advanced peripheral artery disease in one or both legs. Patients will be enrolled at 30 to 40 sites in the United States and Europe. They will be treated with the Tack endovascular system when a dissection occurs after angioplasty with a standard balloon or drug-coated balloon in the superficial femoral and proximal popliteal arteries. Published literature reports that up to 88% of angioplasty procedures result in dissections, noted the company.
The TOBA II study’s National Principal Investigator is William A. Gray, MD, Director of Endovascular Services at Columbia University Hospital in New York, New York. The trial’s first patients were enrolled by Joseph Cardenas, MD, at Yuma Regional Medical Center in Yuma, Arizona.
In the company’s press release, Dr. Gray stated, “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 first of its kind study design. No other vascular implants have been methodically studied following vessel treatment with a drug-coated balloon.”
Dr. Cardenas added, “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.”
In January, 12-month results from the company’s European TOBA study were presented by TOBA Coprincipal Investigator Marc Bosiers, MD, at LINC 2015: the Leipzig Interventional Course in Leipzig, Germany. The data demonstrated the potential of the Tack implant for improving arterial healing after angioplasty. The system allows physicians to repair dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options, stated Intact Vascular.