Printed 14 December 2017
PQ Bypass has gotten conditional approval of their investigational device exemption (IDE) in the US Fda (Food and drug administration) to initiate the pivotal DETOUR II medical trial.
Because the first-ever pivotal trial for percutaneous femoropopliteal bypass, DETOUR II will assess the safety and effectiveness from the DETOUR System in as much as 292 patients with lower limb ischemia because of lengthy blockages (>15 cm) within the superficial femoral artery (SFA) brought on by peripheral artery disease (PAD).
“Patients with existence-restricting claudication or critical limb ischemia normally have lesions more than 15 cm, so we realize that lesion length is directly proportional to patency. So far, endovascular ways of treating these lengthy lesions haven’t been similar to open bypass surgery,” stated Sean P. Lyden, M.D., professor and chairman from the department of vascular surgery, Sydell and Arnold Miller Family Heart & Vascular Institute at Cleveland Clinic, and national co-principal investigator of DETOUR II.
“The DETOUR procedure is made to treat patients with seriously calcified or lengthy-segment disease. It’s basically a femoropopliteal bypass with polytetrafluoroethylene, but done percutaneously. The DETOUR I trial in Europe shown safety and effectiveness in patients with lesions as lengthy as 44 centimeters long, so we expect to ongoing to review this process using the commencement of DETOUR II.”
DETOUR II is really a prospective, single-arm, global multi-center trial and will also be conducted at as much as 40 sites to allow the gathering of safety and effectiveness data meant for a pre-market approval (PMA) submission towards the Food and drug administration.
Furthermore, to show health economic outcomes, the trial features a prospective economic study made to collect data associated with the expense connected with treating PAD within the study population. An financial aspects core lab may lead the gathering of quality-of-existence outcome measures (collected at baseline, thirty days, six and 12 several weeks), and procedural and follow-up costs, including rehospitalizations, through 24 several weeks.
“We labored carefully using the Food and drug administration, leading physicians and healthcare managers to create an effort that people be prepared to demonstrate the entire worth of this excellent method of treating severe PAD,” stated Richard Ferrari, chairman from the board of company directors at PQ Bypass. “DETOUR II is definitely an exciting milestone within the journey toward creating a potentially transformative future standard of take care of these patients.”
Percutaneous femoropopliteal bypass (the DETOUR procedure) is definitely an entirely new procedure enabled by PQ Bypass’ proprietary DETOUR System, which is composed of the TORUS Stent Graft, DETOUR Crossing Device, and DETOUR Snare. The DETOUR procedure results in a path that comes from the SFA, travels with the femoral vein and leads to the popliteal artery, bypassing the diseased area of the artery.
This path enables TORUS Stent Grafts to become put into a continuing line and consistently re-direct oxygen-wealthy bloodstream round the blockage, restoring bloodstream flow towards the calf and feet from the patient. Unlike existing technologies for example stents and drug-coated balloons, which just produce a funnel with the disease and aren’t created for very lengthy blockages, the DETOUR procedure is really a unique solution made to supply the reliability of open bypass surgery however with a non-invasive approach.
“The DETOUR System includes a truly innovative, intuitive design and also the trial will investigate its benefits in addressing lengthy lesions that aren’t well offered by existing minimally-invasive approaches,” stated Jihad A. Mustapha, M.D., clinical affiliate professor of drugs, Michigan Condition College College of Osteopathic Medicine and national co-principal investigator from the DETOUR II Trial. “We expect to dealing with the DETOUR II Trial clinical sites about this important research.”
Source: Company Pr Release