November 4, 2013 — Direct Flow Medical Inc. announced six-month data from the fully enrolled DISCOVER CE mark trial of the Direct Flow Medical Transcatheter Aortic Valve System.
The data, which was presented at the 25th annual Transcatheter Cardiovascular Therapeutics conference (TCT 2013), demonstrated sustained results at six months with 96 percent freedom from all-cause mortality and no incidence of moderate or severe post-procedural aortic regurgitation. Joachim Schofer, M.D., Medical Care Center, Hamburg, Germany and principal investigator presented the results.
The Direct Flow Medical Transcatheter Aortic Valve System is designed to minimize the risk of aortic regurgitation by enabling in-situ hemodynamic assessment during the procedure as well as unlimited repositioning until optimal valve placement is achieved.
The results from the DISCOVER Trial confirm the system’s ability to virtually eliminate aortic regurgitation with no patient experiencing moderate or severe aortic regurgitation at six months. Additionally, the mean gradient of 13 mmHg as measured by echocardiography at six 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 percent VARC defined Combined Safety rate at six 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 following placement, minimizing the risk of hemodynamic instability for patients.
At six months, 78.6 percent of patients improved by one or more New York Heart Association (NYHA) functional classes, and 90 percent of patients were classified as NYHA Class I or II.
“These data show that the excellent results obtained with the Direct Flow Medical system are sustainable over time,” said Schofer. “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.”
“We have developed this true next-generation technology over several years and now have core lab Clinical Events Committee (CEC) and Data Monitoring Committee (DMC)-adjudicated outcomes to prove the performance of this device. The results demonstrate that patients treated with the Direct Flow Medical system show a marked improvement in NYHA class and excellent survival through six months,” said Bernard Lyons, CEO, Direct Flow Medical.
The DISCOVER Trial was a prospective, multi-center study conducted at nine European sites in 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 device studied was the Direct Flow Medical Transcatheter Aortic Valve System, which includes a distinctive heart valve with a metal-free frame delivered transfemorally via a flexible, 18 French delivery system.
“The European-based DISCOVER study has paved the way for the U.S. SALUS I IDE Trial, which initiated enrollment last month,” said Lyons. “We are also working closely with the FDA on the development of the SALUS II pivotal trial and look forwarding to commencement in early 2014.”
The SALUS Trial is a non-randomized, multi-center, core lab-adjudicated, Investigational Device Exemption (IDE) trial being conducted at six U.S. clinical sites. Principal investigators for the SALUS Trial are Murat Tuzcu, M.D., vice chairman, Department of Cardiology, Cleveland Clinic and Patrick McCarthy, M.D., director, Bluhm Cardiovascular Institute and chief of cardiac surgery, Northwestern Memorial Hospital.
The Direct Flow Medical system received the CE mark in January 2013 and is currently commercially available in Europe.
The benefits of the Direct Flow Medical Transcatheter Aortic Valve System are enabled by its design, which features a distinctive, metal-free frame. Rather than a metal stent, the Direct Flow Medical System incorporates a polymer frame that is initially expanded using pressurized saline and contrast for placement, assessment and repositioning. Once optimal valve position is achieved, the saline/contrast solution is easily exchanged for a quick-curing polymer that solidifies and secures the valve in place. The double-ring design of the valve creates a tight seal around the annulus. The system is fully repositionable and retrievable up until polymer exchange. The metal-free design enables a low-profile (18 French), fully sheathed delivery system for all valve sizes that minimizes vascular complications and improves hemodynamic outcomes.
For more information: www.directflowmedical.com