Intact Vascular said today that it finished enrollment for the Toba II clinical trial evaluating its Tack Endovascular System in combination with standard or drug coated balloon angioplasty in arteries above the knee.
The company’s trial enrolled 210 patients and will focus on the superficial femoral artery and the proximal segment of the popliteal artery, according to Intact.
The Tack system is used to repair tears in the artery walls that occur as a complication of angioplasty. The system allows healthcare providers repair tears without leaving as much foreign material in the artery, while reducing mechanical stress and preserving future treatment options, the company said.
“TOBA II is a unique clinical study which will give us important insights into a new approach to dissection repair that holds great promise for advancing the endovascular treatment of peripheral artery disease,” principal investigator Dr. William Gray said in prepared remarks.”I extend my sincere appreciation and congratulations to all of the investigators and their teams for making the timely achievement of this milestone possible.”
The trial will make use of standard balloon angioplasty and drug coated balloon angioplasy with C.R. Bard‘s (NYSE:BCR) Lutonix DCB. Its primary endpoint is duplex-derived patency at 12-months after treatment.
Intact said it is also sponsoring a trial in Europe that is investigating the use of the Tack system with Medtronic‘s (NYSE:MDT) In.Pact Admiral DCB.
“The Tack Endovascular System was conceived as a minimal metal approach to dissection repair, and that idea has become even more important with the advent of drug coated balloon angioplasty,” Intact co-founder & chief medical officer Dr. Peter Schneider added. “The completion of TOBA II enrollment is an exciting step toward FDA approval and ultimately making the Tack Endovascular System broadly available to patients suffering from peripheral arterial disease.”