Company officials describe the Detour system as a breakthrough in the treatment of peripheral arterial disease (PAD), which the CDC estimates affected roughly 6.5 million Americans over 40. The present recommended therapy is open surgical bypass, an invasive procedure.
Endologix said the Detour system offers a new approach called percutaneous transmural arterial bypass (PTAB). It treats complex peripheral artery disease by allowing physicians to bypass lesions in the superficial femoral artery by using stents routed through the femoral vein to restore blood flow to the leg.
“We are delighted to receive FDA approval of the Detour system,” President and CEO Matt Thompson said in a news release. “PTAB therapy represents a significant step forward for patients with complex PAD, they have long needed a more effective and less invasive treatment option for long lesions of the SFA. We are proud to be pioneering this novel approach and continuing to innovate on behalf of patients. We look forward to launching this new therapy in the U.S. through a targeted market release in the coming weeks.”
Endologix suggests that the approach is particularly effective for patients with long lesions (20 cm to 46 cm in length), patients that have already undergone failed end-vascular procedures, or patients that may be sub-optimal candidates for open surgical bypass.
The company said the Detour system adds to its legacy of disruptive vascular therapies to boost patient outcomes.
