PQ Bypass has announced that they received breakthrough device designation from the US Food and Drug Administration (FDA) for the Detour system. The Detour system is the world’s first fully-percutaneous femoral-popliteal bypass device intended to treat extremely long, complex blockages in the superficial femoral artery (SFA).
Physician access to this device can now be expedited as a result of this designation by the FDA breakthrough device programme, which is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the programme, the FDA will provide PQ Bypass with priority review and interactive communication regarding device development and clinical trial protocols, during the premarket review process.
“As this is a first-of-its-kind device, we are pleased to have the FDA recognise the novelty and potential of our therapeutic approach in treating severe SFA,” said Heather Simonsen, general manager at PQ Bypass. “We appreciate their collaborative review of our breakthrough device designation request and look forward to a continued productive relationship as we continue towards PMA submission.”
The Detour system is designed to treat patients who are unable to carry out activities of daily living and are unable to enjoy the liberties of free mobility as a result of their advanced symptomology, severe lesion morphology, and multiple comorbidities.
Once peripheral arterial disease (PAD) progresses to debilitating claudication or tissue loss, revascularisation becomes imperative to mitigate the ongoing deterioration and to prevent amputation. Left untreated, these patients are at greater risk for further functional deterioration, major adverse limb events, and mortality.
“This designation is a major milestone for PQ Bypass, and we expect this technology to change the paradigm for complex SFA treatment in the way EVAR [endovascular aneurysm repair] and TAVR [transcatheter aortic valve replacement] changed the paradigm for aortic repair,” said Rich Ferrari, chairman and CEO of PQ Bypass.
“We are nearing enrolment completion in our DETOUR2 and TORUS2 IDE [investigational device exemption] studies, and had new positive data on our technology published in the Journal of Vascular Surgery, making 2020 a momentous year for the company. This is an exciting time for all of us at PQ, with this important designation a credit to such a talented group. We are honoured and proud to be part of this important journey to develop a first-line therapy in the treatment of advanced PAD.”