The US Food and Drug Administration (FDA) has granted staged approval for Intact Vascular's investigational device exemption (IDE) application to start Tack Optimized Balloon Angioplasty II BTK (TOBA II BTK) clinical study.
The study will assess the safety and efficacy of the Tack endovascular system when used to repair dissections (or tears) in the arteries below the knee (BTK) following percutaneous transluminal angioplasty (PTA) as a treatment for critical limb ischemia (CLI).
The company will recruit around 232 subjects in around 50 US and international sites.
Tack endovascular system will be used to treat study subjects following standard balloon angioplasty in the popliteal or tibial arteries when a dissection occurs.
Tack endovascular system is a new technology developed to repair dissections, which frequently occur as a complication of balloon angioplasty.
The system enables physicians to repair dissections while leaving a minimal amount of foreign material in the artery, helping to reduce mechanical stress on the artery and preserve future treatment options.
Intact Vascular president and CEO Bruce Shook said: "The TOBA II BTK clinical study represents an exciting opportunity to bring the first vascular implant to the U.S. market for the treatment of critical limb ischemia patients.
“We are thrilled with the level of enthusiasm from the clinical community and look forward to collaborating with them on this important advancement for CLI care."
The trial principal investigator Patrick Geraghty said: "Critical limb ischemia is a debilitating condition for many patients with serious downstream consequences such as amputation and loss of independence.”