FDA Approves DETOUR for Percutaneous Bypass in Long, Complex SFA

LEIPZIG, Germany—The US Food and Drug Administration has now approved the DETOUR System for the treatment of long, complex superficial femoropopliteal lesions, according to manufacturer Endologix.

“Percutaneous transmural arterial bypass (PTAB) with the DETOUR System offers a novel approach to treating complex PAD, enabling physicians to bypass lesions in the superficial femoral artery, by using stents routed through the femoral vein to restore blood flow to the leg,” a press release notes. “This approach is particularly effective for patients with long lesions (20 cm-46 cm in length), those that have already undergone failed endovascular procedures, or those that may be suboptimal candidates for open surgical bypass.”

In October 2022, the company announced it had submitted a premarket approval application to the agency. Data from the DETOUR 2 investigational device exemption study of 220 patients showed 12-month primary patency of 72.1% in lesions with a mean length of 32.7 cm, plus a 30-day major adverse event rate of 7%.

Here at LINC 2023, TCTMD asked Sean P. Lyden, MD (Cleveland Clinic, OH), for his feedback on the news. “We treat a unique patient population and we know that whether [we use] balloons, drug-coated balloons, drug-eluting stents, or covered stents, they work well, but these lesion lengths are longer and many of these patients fail endovascular therapy because of that,” said Lyden, a principal investigator for DETOUR 2 and earlier research on the product.

“This gives us another tool in our toolbox to do bypasses percutaneously. It’s not for every patient, but for the long, complex lesions, I think it fills some gaps that we need,” he added.

The DETOUR System was given a breakthrough device designation by the FDA in 2020 and received CE Mark approval in Europe in 2017.