The DETOUR 2 study is a prospective, single-arm, international, multi-center clinical evaluation of the novel DETOUR™ System for fully percutaneous femoropopliteal bypass procedures.
IRVINE, Calif., June 23, 2022--(BUSINESS WIRE)--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 ENDOCROSS™ catheter and TORUS™ stent 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
"This system has potential to introduce a novel, minimally invasive alternative for patients in need of a femoropopliteal bypass. The low complications, coupled with the 72% primary patency in these long lesions, provide positive evidence for the feasibility of this new technology in a difficult clinical setting," said Dr. Lyden.
"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."
Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease. Endologix’s portfolio includes a variety of products in various stages of development that are designed to treat diseases that currently have clinically relevant unmet needs. These products are designed to treat a wide spectrum of vascular disease from abdominal aortic aneurysms to lower limb peripheral vascular disease. Endologix’s current commercial EVAR products include the AFX®2 device and the ALTO® Abdominal Stent Graft System. Endologix became a private company, wholly owned by Deerfield Management in October 2020. In April 2021 Endologix completed the acquisition of PQ Bypass, Inc., a privately held medical technology company pioneering a first-of-its-kind technology that addresses an unmet need for new treatments for severe peripheral arterial disease (PAD).
The company has offices and manufacturing sites in Irvine and Santa Rosa. To learn more about Endologix, please visit http://www.endologix.com/.
About Deerfield Management
Deerfield is an investment management firm committed to advancing healthcare through investment, information, and philanthropy. For more information, please visit www.deerfield.com.
Except for historical information contained herein, this press release contains forward-looking statements, including statements regarding the effectiveness of treatment utilizing, and the timing and success of regulatory submissions for, products under development. Forward looking statements are subject to risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. The forward-looking statements contained in this press release speak only as of the date of this press release and Endologix undertakes no obligation to update any forward-looking statements contained in this press release to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
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