Six-Month DISCOVER Data Presented for Direct Flow Medical's TAVR System

October 29, 2013—Direct Flow Medical, Inc. (Santa Rosa, CA) announced that 6-month data from the DISCOVER CE Mark trial of the company's transcatheter aortic valve replacement (TAVR) system were presented by Principal Investigator Joachim Schofer, MD, at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California.

The company advised that the Direct Flow Medical TAVR system received European CE Mark approval in January 2013 and is commercially available in Europe.

The DISCOVER trial is a prospective, multicenter study conducted at nine European sites. The trial enrolled 100 patients with severe aortic valve stenosis requiring replacement of the native aortic valve but who were at extreme risk for open surgical repair.

According to the company, the DISCOVER data continue to affirm the outcomes and safety profile of the Direct Flow TAVR system, demonstrating sustained results at 6 months, with 96% freedom from all-cause mortality and no incidence of moderate or severe postprocedural aortic regurgitation. Postprocedural aortic regurgitation after TAVR has been shown to be a predictor of long-term mortality, noted the company.

Additionally, the mean gradient of 13 mm Hg, as measured by echocardiography at 6 months, demonstrates that the Direct Flow Medical valve can significantly reduce and maintain low transvalvular gradients over time. All hemodynamic outcomes were assessed and reported by an independent imaging core laboratory.

The strong safety profile of the Direct Flow Medical system was confirmed with a 97% Valve Academic Research Consortium-defined combined safety rate at 6 months with no additional strokes (major or minor) and no patient experiencing a myocardial infarction in the evaluable cohort. The system avoids rapid pacing of the heart during deployment and does not require post-dilatation after placement, minimizing the risk of hemodynamic instability for patients, stated the company.

At 6 months, 78.6% of patients improved by one or more New York Heart Association (NYHA) functional classes and 90% of patients were classified as NYHA class I or II. The company noted that these outcomes that were adjudicated by a core lab Clinical Events Committee and a Data Monitoring Committee prove the performance of this device.

In the company's press release, Prof. Schofer, who is from the Medical Care Center in Hamburg, Germany, commented, “These data show that the excellent results obtained with the Direct Flow Medical system are sustainable over time. The Direct Flow Medical system is able to virtually eliminate aortic regurgitation with outstanding patient safety. These results continue to be unprecedented for a TAVI device.”

Direct Flow Medical stated that the European-based DISCOVER study paved the way for the SALUS I feasibility trial, conducted under an investigation device exemption in the United States trial. SALUS I, which initiated enrollment in September 2013, is a nonrandomized, multicenter, core lab-adjudicated trial being conducted at six clinical sites in the United States. Principal Investigators for the SALUS trial are Murat Tuzcu, MD, from the Cleveland Clinic Foundation in Cleveland, Ohio, and Patrick McCarthy, MD, from Northwestern Memorial Hospital in Chicago, Illinois. The company is also developing the SALUS II pivotal trial to commence in early 2014.

Direct Flow Medical's TAVR system's metal-free polymer is initially expanded using pressurized saline and contrast for placement, assessment, and repositioning. When optimal valve position is achieved, the saline/contrast solution is exchanged for a quick-curing polymer that solidifies and secures the valve in place. The valve's double-ring design creates a tight seal around the annulus. The system is fully repositionable and retrievable up until polymer exchange. The metal-free design enables a flexible, low-profile 18-F, fully sheathed transfemoral delivery system for all valve sizes that minimizes vascular complications and improves hemodynamic outcomes, according to the company.