16 November 2020 - - US-based medical device company PQ Bypass, Inc is touting promising long-term safety and effectiveness results from 24-month follow-up data from the DETOUR1 Clinical Study, including a 79% primary patency, with 82% of patients maintaining freedom from major adverse events at 2 years post-procedure, the company said.

The DETOUR1 trial is the first-in-man trial of the FDA-designated Breakthrough Device, The Detour System, evaluating the safety and effectiveness of the novel procedure and device system for treating long, complex lesions in the superficial femoral artery.

The data were released as one of the "10 Highly Anticipated Late-Breaking Clinical Trial Releases" during the VIVA 2020 Virtual Conference.

The data release, titled "24-Month Outcomes from the DETOUR1 Trial for Percutaneous Femoropopliteal Bypass," was presented by Ehrin Armstrong, MD, Professor of Medicine-Cardiology at the University of Colorado School of Medicine.

Eight participating centers enrolled 81 limbs with complex, long-segment femoropopliteal lesions with moderate to severe calcification in lesions averaging 37cm across the trial and a 96% prevalence of CTO.

PQ Bypass' proprietary Detour platform for percutaneous femoropopliteal bypass–designated by the FDA as a Breakthrough Device–is designed to be a significant technological advancement enabling novel, transformational interventions in outpatient settings.

PQ Bypass is a former company-In-Residence at the Fogarty Institute for Innovation.

PQ Bypass is currently sponsoring two multicenter IDE trials, DETOUR2 and TORUS2, focused on complex SFA disease.

PQ Bypass is recognized by MedTech Outlook magazine as one of the Top 10 Cardiovascular Companies of 2019 and earned Frost and Sullivan's European Technology Innovation award in 2017.

The Detour System received FDA Breakthrough Device Designation in October 2020. The Detour System and the TORUS Stent Graft are limited by federal law to investigational use only and are not available for sale.