US-based Boston Scientific has started a REPRISE III clinical trial designed to assess the safety and effectiveness of the Lotus Valve System in patients with severe aortic stenosis.
The trial will evaluate patients who are considered to be at either high or extreme risk for surgical valve replacement.
As part of the REPRISE III trial, a clinical team led by Dr Feldman implanted the first three Lotus Valve Systems at Evanston Hospital.
Boston Scientific vice-president and general manager of structural heart Tom Fleming said: "Completing the first patient implantations of the Lotus Valve System as part of the REPRISE III IDE trial marks an important step in bringing this innovative technology to physicians and patients in the US.
"It demonstrates the commitment of Boston Scientific to building upon a body of clinical evidence and advancing care for patients who suffer from this debilitating disease."
The company said that the system is the first transcatheter aortic valve replacement (TAVR) device that is both fully repositionable and retrievable prior to release.
Aortic valve stenosis is the process of thickening and stiffening in the valve, which results in reduction in blood flow.
Primary endpoints of the REPRISE III trial are safety: composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage two or three acute kidney injury or major vascular complications at 30 days, and efficacy: composite of all-cause mortality, disabling stroke or moderate or greater paravalvular aortic regurgitation (leaking) at one year following procedure.
The Lotus Valve System has shown sustained safety and better outcomes in the REPRISE I and REPRISE II clinical trials, and the company intends to build on that data in the REPRISE III trial.
Dr Feldman said: "New data from REPRISE I and REPRISE II, which were presented last week at TCT 2014 in Washington, DC, demonstrate remarkably low rates of paravalvular leakage and all-cause mortality.
"We believe that REPRISE III, which is slated to involve more than 1,000 patients, will confirm these data and show that the Lotus Valve System has the potential to improve patient outcomes beyond what we’ve seen with first generation devices."