Direct Flow Medical's TAVR System Supported by 12-Month DISCOVER Data

May 22, 2014—Direct Flow Medical, Inc. announced 12-month outcomes from the DISCOVER CE Mark trial evaluating the Direct Flow Medical transcatheter aortic valve replacement (TAVR) system. Principal investigator Joachim Schofer, MD, from the Medical Care Center, Hamburg, Germany, presented the data at the EuroPCR 2014 congress being held May 20–23 in Paris, France.

The fully repositionable and retrievable Direct Flow Medical system is designed to treat patients with severe aortic stenosis who are at high or extreme surgical risk while reducing the risk of postprocedural aortic regurgitation (AR).

The Direct Flow Medical system received CE Mark approval in January 2013 and is currently available commercially in Europe. The 29-mm valve received CE Mark in December 2013, and the 23-mm valve is pending CE Mark approval.

The initial DISCOVER trial was a prospective, multicenter study conducted at nine European sites of 100 patients with severe aortic valve stenosis who required replacement of their native aortic valve but were at extreme risk for open surgical repair. The trial has since expanded to additional sites and patients, enrolling patients in 23-mm–valve and 29-mm–valve trial arms.

According to the company, trial patients treated with the Direct Flow system experienced excellent overall hemodynamic results, as well as a low rate of procedural complications.

The trial investigators reported a 90% survival rate at 12 months, continuing the initial positive trend of 99% survival. Also at 12 months, 100% of patients experienced mild or less AR, with 77% having none or trace AR.

In the company’s press release, Dr. Schofer commented, “The 12-month DISCOVER results are unprecedented for a TAVR device. The Direct Flow Medical system has demonstrated that it successfully treats aortic stenosis with low mortality, while at the same time addressing the very serious issue of aortic regurgitation in a clinically meaningful way in order to significantly improve patient outcomes.”

The 12-month mean transthoracic echo gradient was 12.3 mm Hg, which sustained the low 30-day gradient measurement of 12.5 mm Hg. All hemodynamic outcomes were assessed and reported by an independent imaging core laboratory. The device success rate (defined by the Valve Academic Research Consortium) was 91%. At 30 days, 83% of patients had improved by more than one New York Heart Association (NYHA) functional class, and this was maintained at 12 months, with 95% classified as NYHA Class I/II, reported Direct Flow Medical.