Endologix Files PMA for Detour System
Endologix has submitted an Premarket Approval (PMA) application to the FDA for its Detour system for percutaneous femoropopliteal bypass that is routed through the femoral vein to treat patients with moderate-to-severe peripheral arterial disease with long blockages of the superficial femoral artery.
The application is supported by results from an Investigational Device Exemption study which showed a 12-month primary patency of 72.1 percent in superficial femoral artery lesions. Primary patency refers to the freedom from clinically driven revascularization and freedom from restenosis.
The Detour system has already received a Breakthrough Device designation from the FDA. The agency grants the designation to certain medical devices that may offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.