Intact Vascular's TOBA II BTK Pivotal IDE Study Approved by FDA

October 31, 2016—Intact Vascular, Inc. announced that the US Food and Drug Administration (FDA) granted staged approval for the company’s investigational device exemption application to begin the Tack Optimized Balloon Angioplasty II BTK (TOBA II BTK) clinical study, which will examine the safety and efficacy of Intact’s Tack endovascular system when used to repair dissections in below-the-knee (BTK) arteries after percutaneous transluminal angioplasty treatment for critical limb ischemia (CLI).

Patrick J. Geraghty, MD, and George Adams, MD, will serve as national Principal Investigators for the study. Dr. Geraghty is Professor of Surgery and Radiology at the Washington University School of Medicine of St. Louis, in St. Louis, Missouri. Dr. Adams is Director of Cardiovascular and Peripheral Vascular Research at UNC Rex Hospital in Raleigh, North Carolina.

According to Intact Vascular, the TOBA II BTK study is designed to enroll 232 patients at up to 50 United States and international sites. Patients experiencing symptoms from advanced BTK peripheral artery disease will be eligible for enrollment in the study.  Patients in the study will be treated with the Tack endovascular system after standard balloon angioplasty in the popliteal or tibial arteries when a dissection occurs.

In the company’s press release, Dr. Geraghty commented, “CLI is a debilitating condition for many patients with serious downstream consequences, such as amputation and loss of independence. The disease is growing rapidly, especially with the increasing incidence of diabetes, creating an urgent need for more effective treatments. The TOBA II BTK study represents an exciting opportunity to improve the long-term results associated with angioplasty, which is our primary, minimally invasive treatment for CLI. This study is the first pivotal trial ever conducted in the United States supporting the FDA approval of an implantable device for CLI treatment.”

Dr. Adams added, “We are very enthusiastic about the commencement of the TOBA II BTK clinical study. The Tack endovascular system is uniquely tailored for use in arteries BTK. These arteries are small in diameter, so the minimal metal burden associated with the Tack implant and the Tack implant’s ability to adapt to the diameter of the artery are both ideal for dissection repair in this part of the leg.”

The company noted that in July 2016, promising 12-month results from the TOBA study, which examined the use of the Tack implant to treat dissections above the knee, were published in the Journal of Vascular Surgery (2016;64:109–116). Additionally, the 12-month results from the TOBA BTK pilot study were presented in May at SCAI 2016, the Society for Cardiac Angiography and Interventions annual meeting. Both studies demonstrated the potential of the Tack implant to improve arterial healing following angioplasty above the knee and BTK, stated Intact Vascular.