The DETOUR 2 study is a prospective, single-arm, international, multi-center clinical evaluation of the novel DETOURTM System for fully percutaneous femoropopliteal bypass procedures
The DETOUR System uses the ENDOCROSSTM catheter and TORUSTMstent graft to perform a totally percutaneous femoro-popliteal bypass routed through the femoral vein. (Credit: Narupon Promvichai from Pixabay)
Endologix LLC, a privately held global medical device company dedicated to improving patients’ lives with innovative interventional treatments for vascular disease, recently announced the 12-month results from the DETOUR 2 clinical trial. DETOUR 2 was an Investigational Device Exemption (IDE) study, designed to evaluate safety and effectiveness of the DETOUR System for percutaneous bypass in the treatment of long-segment femoropopliteal disease. The DETOUR System uses the ENDOCROSSTM catheter and TORUSTMstent graft to perform a totally percutaneous femoro-popliteal bypass routed through the femoral vein.
The National Principal Investigators of DETOUR 2 were Sean Lyden MD, Chairman of the Department of Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute and Jihad Mustapha MD, FACC, FSCAI President and Chief Executive Officer and Director of Endovascular Interventions at Advanced Cardiac & Vascular Centers for Amputation Prevention. The 12-month results from the DETOUR 2 Study were presented during a plenary session at the 2022 Annual Meeting of the Society of Vascular Surgery by Dr. Lyden.
The Detour 2 clinical trial enrolled 202 patients in the United States and Europe for the primary analyses. This cohort represents a patient population with severe femoropopliteal artery disease. Ninety-six percent of the patients had chronic total occlusions (CTO), the mean lesion length was 327.14 mm with a CTO length of 217.31 mm, and 70.4% had severe calcification.
The results presented are listed below:
- Primary patency was 72.1% (Kaplan-Meier Estimate) at 12-months
- The major adverse event rate was 7% at 30-days
- The incidence of Deep Vein Thrombosis (DVT) of 2.5% and 4.1% at 30 days and 12 months, respectively
- No pulmonary emboli occurred through 12-months
“The DETOUR 2 Study is an important step forward in a new endovascular treatment to address an area of a challenging clinical need for patients. The PMA application for the Detour System, designated as a Breakthrough Device by the FDA, will be submitted to the US FDA shortly,” said Matt Thompson, MD, President and CEO of Endologix. “We are excited to be taking a step towards expanding treatment options in the femoropopliteal segment so that vascular surgeons can offer their patients this disruptive technology. Additionally, this trial is an important milestone as we continue to transform Endologix and expand our interventional vascular portfolio.”
Source: Company Press Release