Two-Year Data Reported for Direct Flow Medical's TAVR System

May 19, 2015—Direct Flow Medical, Inc., announced that 2-year data from the DISCOVER CE Mark Trial, which studied the Direct Flow Medical transcatheter aortic valve replacement (TAVR) system, were presented by Antonio Colombo, MD, at the EuroPCR conference being held May 19–22 in Paris, France.

The DISCOVER CE Mark Trial is a prospective, multicenter study conducted at nine European sites that enrolled 100 patients with severe aortic valve stenosis who required replacement of their native aortic valve but were at extreme risk for open surgical repair.

According to the company, the trial demonstrated an 80% survival rate at 24 months, continuing the positive trend showing 90% survival rate after 1 year and 99% after 30 days. All patients experienced mild or less postprocedural aortic regurgitation (AR), with 85% having none or trace AR. The mean gradient remained stable at 12.4 mm Hg at 24 months compared to 12.6 mm Hg at 30 days.

At the 2-year mark, 92% of patients had improved by more than one New York Heart Association (NYHA) functional class, whereas only 83% of patients had improved by more than one NYHA functional class at 30 days. All hemodynamic outcomes were assessed and reported by an independent imaging core laboratory and were sustained over time, noted the company.

In the company’s press release, Dr. Colombo commented, “The 24-month DISCOVER results demonstrate that the initial clinical improvements seen with the Direct Flow Medical valve translate into exceptional long-term outcomes. This next-generation TAVR device is the first to report such outstanding results treating an extremely sick patient population.” Dr. Colombo is from the Ospedale San Raffaele in Milan, Italy.

The Direct Flow Medical system received European CE Mark approval in January 2013 and is currently available commercially in Europe. The company is enrolling a pivotal investigational device exemption trial in the United States, where the device is not commercially available.

The fully repositionable and retrievable Direct Flow Medical system is indicated to treat patients with severe aortic stenosis who are at extreme surgical risk. The device reduces the risk of postprocedural AR by sealing the annulus and enabling complete assessment of hemodynamic performance with in situ repositioning of the valve after full deployment.

Additionally, the Direct Flow Medical system avoids both rapid pacing of the heart during deployment and postdilatation after placement, minimizing the risk of hemodynamic instability for patients. The device includes a distinctive heart valve with a metal-free frame, delivered transfemorally via the same flexible delivery system for all sizes (23, 25, 27, and 29 mm), stated the company.