Endologix TORUS 2 Study Completes Enrollment

November 23, 2021—Endologix LLC announced the completion of enrollment in the TORUS 2 IDE clinical study. Conducted in the United States under an FDA investigational device exemption, the study was designed to evaluate the safety and effectiveness of the company’s Torus stent graft system in the treatment of obstructive atherosclerotic lesions of the native superficial femoral artery (SFA) and proximal popliteal arteries. The prospective, single-arm multicenter trial enrolled 188 patients.

The study is led by National Coprincipal Investigators Peter Schneider MD, and Ehrin Armstrong MD.

Dr. Schneider is Professor of Surgery, Division of Vascular and Endovascular Surgery at University of California San Francisco in San Francisco, California. Dr. Armstrong is Medical Director, Adventist Heart and Vascular Institute at Adventist Health St. Helena in St. Helena, California.

“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,” commented Dr. Armstrong in the Endologix press release.

Dr. Schneider added, “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.”

In November 2019, PQ Bypass, Inc. announced the commencement of the pivotal TORUS 2 trial.

In April 2021, Endologix announced the acquisition of PQ Bypass.