Thirty-Day Results Presented at TCT for Direct Flow Medical's TAVR System

October 23, 2012—Direct Flow Medical, Inc. (Santa Rosa, CA) announced findings from its DISCOVER CE Mark trial at the TCT 2012: Transcatheter Cardiovascular Therapeutics conference in Miami, Florida.

According to the company, the DISCOVER trial is evaluating the Direct Flow Medical transcatheter aortic valve system, which is endovascularly delivered via an 18-F introducer sheath. The trial is a prospective, multicenter study of patients with severe aortic valve stenosis who require replacement of their native aortic valve but are at extreme risk for open surgical repair. Up to 100 patients are being enrolled at 10 European sites. The trial was initiated in November 2011. Coprincipal Investigator Thierry Lefevre, MD, treated the first patient at the L'Institut Jacques Cartier in Massy, France.

In its press release, the company stated that DISCOVER met its primary mortality endpoint. The study also demonstrated that > 95% of patients had mild or less aortic regurgitation, and no patients experienced vascular complications. An independent imaging core laboratory analyzed all hemodynamic results.

At the TCT meeting, Coprincipal Investigator Prof. Joachim Schofer, MD, from the Medical Care Center in Hamburg, Germany, presented 30-day results for the prespecified CE Mark cohort of 33 patients. Prof. Schofer reported that 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%. Freedom from all-cause cardiovascular mortality at 30 days was 100%.

The Direct Flow valve resulted in 97% mild or less aortic regurgitation, with 81% of patients experiencing none/trace aortic regurgitation, as reported by the study core lab. There were no major vascular complications in any patients postprocedure through 30 days, even though the minimum vessel diameter treated in the study was 5.2 mm. The mean gradient preprocedure to discharge and out to 30 days of 46, 13.6, and 12.9 mm Hg, respectively, demonstrated the ability to significantly reduce gradients over time.

The secondary endpoints of safety (defined by Valve Academic Research Consortium) had a combined rate of 9%. In the study, there were two strokes (major or minor) and one patient had a mild myocardial infarction. The device success rate was 97%. The average age of patients in the CE Mark cohort was 83 years, with logistic EuroSCORE/STS scores of 27% and 11%, respectively.

“We are pleased to report the positive initial results for the Direct Flow Valve, as it resolves one of the most important clinical issues in the TAVR market today—aortic regurgitation,” commented Prof. Schofer. “In the trial, we also found that the device was easy to use, offered maximum control and resulted in precise placement. This novel device has the potential to improve clinical outcomes globally and better serve the needs of a growing patient population.”

According to the company, the Direct Flow Medical transcatheter aortic valve system utilizes an inflatable cuff with a conforming polymer support structure. Inflatable rings at the top and bottom of the valve are designed to conform and seal above and below the native valve to virtually eliminate aortic regurgitation. The lack of a metallic frame allows for a low-profile, flexible, fully sheathed system with the potential to reduce bleeding and vascular complications, particularly in patients with tortuous and variable anatomy. Full-thickness bovine pericardial leaflets are incorporated in the valve design for durability. The valve can be repositioned even after the implant is fully expanded to its final configuration, providing a unique ability to assess clinical outcomes before final deployment. The Direct Flow valve is an investigational device, limited by applicable law to investigational use and not available for sale, advised Direct Flow Medical.