The TORUS 2 study is a prospective, single-arm trial of 188 patients to evaluate safety and effectiveness of the TORUS Stent Graft System. in the treatment of PAD in the SFA and proximal popliteal arteries.
IRVINE, Calif. November 23, 2021—Endologix LLC, a privately held global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease, completed enrollment in the TORUS 2 IDE clinical study (NCT04130737) in the United States. The study was designed to evaluate safety and effectiveness of the TORUS Stent Graft System in the treatment of obstructive atherosclerotic lesions of the native SFA and proximal popliteal arteries.
The study is led by national co-principal investigators Peter Schneider M.D., Professor of Surgery, Division of Vascular and Endovascular Surgery at University of California San Francisco, and Ehrin Armstrong M.D., MSc, FACC, FSCAI, FSVM, Medical Director, Adventist Heart and Vascular Institute at Adventist Health St. Helena. “The development of a new self-expanding covered stent for treatment of the SFA and proximal popliteal arteries represents an important advancement in optimal endovascular therapy of complex lesions,” said Ehrin Armstrong, MD.
“We especially appreciate the strong efforts of our clinical trial sites to enroll this trial efficiently and with high quality. This is the first time in years that a new and specifically designed stent graft for the femoral-popliteal segment is being evaluated for clinical utility,” said Peter Schneider, MD.
“The completion of enrollment for TORUS 2 is a significant milestone in a clinically-challenging area of vascular disease,” said Matt Thompson, MD, President and CEO of Endologix. “The TORUS stent-graft is also a pivotal component of the DETOUR procedure, a totally percutaneous femoropopliteal bypass, currently under clinical investigation. Both systems continue our commitment to expanding the Endologix portfolio of innovative devices and supporting clinical evidence.”
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 therapeutic 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. Excellent clinical outcomes will be achieved through meticulous attention to product design, manufacturing, and training, all backed by industry-leading clinical evidence. 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 on Oct. 1, 2020. On April 13, 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 https://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 regulatory submissions for our long-lesion PAD 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.