Intact Vascular announced that a dissection repair device for patients with peripheral artery disease after undergoing an angioplasty has been approved by the FDA.
Approval of the device (Tack Endovascular System, Intact Vascular) was based on results from the TOBA II trial, according to a press release from the company.
As Cardiology Today’s Intervention previously reported, in TOBA II, the endovascular implant used to repair dissections caused by plain or drug-coated balloons during angioplasty in peripheral procedures was associated with positive outcomes including 30-day freedom from new-onset major adverse events and primary patency at 12 months.
“I look forward to having the Tack implant available for my patients,” William Gray, MD, system chief of the division of cardiovascular disease at Main Line Health and president of the Lankenau Heart Institute in Wynnewood, Pennsylvania, said in the release. “Post-angioplasty dissections can significantly impact patient outcomes. Having a minimal metal solution that specifically addresses dissections and improves angioplasty results while preserving future treatment options is extremely exciting.”
Intact Vascular is currently planning a limited release in the U.S. as a result from the FDA approval, according to the release.
Disclosure: Gray reports he received honoraria from Boston Scientific and Medtronic, consulted for Abbott Vascular, Boston Scientific, Cook Medical, Intact Vascular, Medtronic and W.L. Gore and Associates, holds equity in BioCardia, Contego Medical and Silk Road Medical and received research funding from Boston Scientific, Intact Vascular and W.L. Gore and Associates.