Intact Vascular said today it launched the Tack Optimized Balloon Angioplasty III clinical trial investigating its Tack endovascular system along with Medtronic‘s (NYSE:MDT) Admiral drug-coated angioplasty balloon for treating peripheral arterial disease.
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 Tack endovascular system is the ideal adjunct to drug-coated balloon angioplasty. It allows physicians to treat arterial damage in a highly targeted way and address their goals of reducing stress and irritation on the artery. We have a robust clinical development portfolio that is designed to demonstrate the power of this technology combination on the endovascular treatment of PAD,” clinical affairs veep Marc Penna said in a press release.
Enrollment for the trial has opened, and the 1st patient in the trial has been treated by Dr. Klaus Brechtel at Berlin, Germany’s Franziskus-Hospital, the company said.
“One of our key goals when using drug coated balloons to perform peripheral angioplasty is to minimize inflammation of the treated artery and leave little foreign material behind. The Tack system is designed to allow us to repair arterial damage after angioplasty while minimizing vessel irritation and leaving far less metal behind than we would with the traditional stenting approach. The Toba III trial will provide us with valuable information about the combination of two very promising technologies designed to treat PAD. We are thrilled to be the first center to begin enrollment in this important study,” Brechtel said in prepared remarks.
The multi-site Toba III trial is slated to enroll 200 patients with PAD, including a subgroup of patients with long arterial lesions, the company said.
In September, Intact Vascular said it won FDA Investigative Device Exemption for the Toba II trial of its Tack endovascular system for patients with peripheral arterial disease undergoing percutaneous angioplasty.
Currently running, the Toba II study is exploring the combination of the Tack system along with C.R. Bard‘s (NYSE:BCR) Lutonix DCB in patients with superficial femoral and popliteal artery disease.
The company has plans to conduct a trial to investigate the performance of the tack system following balloon angioplasty in patients with arterial disease below the knee.
