Intact Vascular said today it launched the Toba II BTK clinical trial to evaluate the safety and efficacy of its Tack endovascular system along with standard balloon angioplasty for treating critical limb ischemia in the popliteal and tibial arteries.
The Wayne, Penn.-based company said it enrolled the 1st patient in the trial at Yuma, Ariz.’s Yuma Regional Hospital and Heart, Lung and Vascular Center. The 1st patient in the trial was treated by Dr. Joseph Cardenas.
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.
“One of our key goals when we perform angioplasty in patients with CLI is to restore blood flow to the foot, and keeping the treated arteries open over time is a major challenge. The Tack system is uniquely designed to repair dissections following angioplasty while minimizing arterial inflammation and leaving little foreign material behind. I believe this represents an ideal combination for maintaining long term arterial patency. The Toba II BTK trial will provide us with valuable information about this very promising technology designed to optimize angioplasty results in CLI. We are thrilled to be the first center to begin enrollment in this important study,” Dr. Cardenas said in prepared remarks.
The company said the 232-patient prospective Toba II BTK trial is the 1st industry sponsored pivotal clinical trial approved by the FDA to explore the use of permanent vascular implants in arteries below the knee.
“Patients with CLI have significant comorbidities and an increased risk for amputation, yet they have very few treatment options. The commencement of the Toba II BTK trial represents an exciting step toward making the Tack Endovascular System available as new endovascular treatment for this debilitating disease,” CEO & prez Bruce Shook said in a press release.
Last month, Intact Vascular said it won CE Mark approval in the European Union for its Tack endovascular system to repair arterial dissections after percutaneous transluminal angioplasty below the knee. The indication extends the system’s use in the EU to the tibial arteries between the knee and the ankle.
The CE Mark was supported by data from the company’s TOBA BTK clinical trial, which examined the use of the Tack device to repair dissections in tibial arteries following PTA. The data showed 78.4% patency after 12 months and a 93.5% freedom from re-intervention.