No sooner had we covered the news that transcatheter heart valve innovator Direct Flow Medical®, Inc., had gained FDA’s approval to start the pivotal stage of its U.S. clinical IDE trial, than the company then trumpets positive 12 month outcomes from the DISCOVER CE Mark Trial. Results were featured at this week’s EuroPCR in an oral presentation by principal investigator Joaquim Schofer, MD, from the Medical Care Center, Hamburg, Germany.
Direct Flow’s claim to fame is that its transcatheter aortic valve uniquely features no metal frame and achieves its ultimate optimium position using a clever pair of “inflatable” rings. By making the device fully repositionable and retrievable Direct Flow expects to deliver improved clinical results, especially focusing on reducing post-procedural aortic regurgitation(AR), a strong predictor of long term mortality.
So to the DISCOVER Trial’s 12 month outcomes as presented by principal investigator Joaquim Schofer, MD, from the Medical Care Center, Hamburg, Germany. 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 23mm valve and 29mm valve trial arms. The 29mm valve received CE Mark in December 2013 and the 23mm valve is pending CE Mark approval.
Results showed a 90 percent survival rate, continuing the initial positive trend of 99 percent survival after 30 days. Patients treated with the Direct Flow system experienced excellent overall hemodynamic results, as well as a low rate of procedural complications. At 12 months, 100 percent of patients experienced mild or less AR, with 77 percent having none or trace levels.
The mean transthoracic echo gradient at 30 days was 12.5mmHg and remained low at 12 months (12.3mmHg). All hemodynamic outcomes were assessed and reported by an independent imaging core laboratory. The VARC Defined Device Success rate was 91 percent. At 30 days, 83 percent of patients had improved by more than one New York Heart Association (NYHA) functional class and this was maintained at 12 months, with 95 percent classified as NYHA Class I/II.
“The 12 month DISCOVER results are unprecedented for a TAVI device,” said Professor Schofer. “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.”
Source: Direct Flow Medical, Inc.