Direct Flow Medical (Santa Rosa, CA) reported initial results of a clinical study of its Transcatheter Aortic Valve System that met its primary mortality endpoint and that “greater than 95 percent of patients had mild or less aortic regurgitation, and no patients experienced vascular complications.”
The valve is made of a polymer frame, bovine pericardium leaflets, and two inflatable rings that sit on both sides of the patient’s own valve, completely taking over its space. Because the rings can deflate as well, the valve can be easily repositioned for a better fit or removed if complications occur.
Some of the findings reported from the study:
The DISCOVER Trial is a prospective, multicenter study of up to 100 patients conducted at 10 European sites of patients with severe aortic valve stenosis who require replacement of their native aortic valve but are at extreme risk for open surgical repair. The device studied was the Direct Flow Medical Transcatheter Aortic Valve System, which is endovascularly delivered via an 18F introducer sheath. The trial was initiated in November 2011 and the first patient was treated at the L’Institut Jacques Cartier in Massy, France by Co-Principal Investigator Thierry Lefevre, MD.
In the presentation of 30 day results for the pre-specified CE Cohort of 33 patients reported by Co-Principal Investigator Joachim Schofer, MD from the Medical Care Center, Hamburg, Germany, all patients were successfully treated via a transfemoral approach using the low profile, flexible Direct Flow Delivery System. The primary endpoint, freedom from all-cause mortality from procedure to 30 days, was met at 97 percent. Freedom from all cause cardiovascular mortality at 30 days was 100 percent.
Importantly, the Direct Flow Valve resulted in 97 percent mild or less aortic regurgitation, with 81 percent of patients experiencing none/trace aortic regurgitation as reported by the study Corelab. There were no major vascular complications in any patients post-procedure through 30 days even though the minimum vessel diameter treated in the study was 5.2 mm. The mean gradient pre-procedure to discharge and out to 30 days of 46.0, 13.6 and 12.9 mmHg, respectively, demonstrated the ability to significantly reduce gradients over time. All hemodynamic results were analyzed by an independent imaging core laboratory.
Product page: Direct Flow Medical percutaneous aortic valve
Press release: Direct Flow Medical® Transcatheter Aortic Valve System Shown To Virtually Eliminate Aortic Regurgitation With No Vascular Complications In DISCOVER CE