Endologix has completed enrolment in the TORUS 2 investigational device exemption (IDE) clinical study in the USA, a press release reports.
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 peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal arteries.
The study is led by national co-principal investigators Peter Schneider, professor of surgery, Division of Vascular and Endovascular Surgery at University of California San Francisco (San Francisco, USA), and Ehrin Armstrong, medical director, Adventist Heart and Vascular Institute at Adventist Health St Helena (St Helena, USA). “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 Armstrong.
“We especially appreciate the strong efforts of our clinical trial sites to enrol 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 Schneider.
“The completion of enrolment for TORUS 2 is a significant milestone in a clinically challenging area of vascular disease,” said Matt Thompson, 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.”