SAN FRANCISCO--(EON: Enhanced Online News)--Direct Flow Medical®, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, today announced six-month data from the fully-enrolled DISCOVER CE Mark Trial that continue to affirm the excellent outcomes and strong safety profile of the Direct Flow Medical® Transcatheter Aortic Valve System. The data, which were presented on Monday at the Transcatheter Cardiovascular Therapeutics (TCT) conference, 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. Principal Investigator Joachim Schofer, M.D., from the Medical Care Center, Hamburg, Germany, presented the results.
“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.”
Post-procedural aortic regurgitation following transcatheter aortic valve replacement (TAVR) has been shown to be a predictor of long-term mortality1. 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 13.0mmHg 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 Professor 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, Chief Executive Officer of Direct Flow Medical.
The DISCOVER Trial is a prospective, multi-center study conducted at nine European sites in 100 patients with severe aortic valve stenosis who require replacement of their native aortic valve but are 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, IDE trial being conducted at six U.S. clinical sites. Principal investigators for the SALUS Trial are Murat Tuzcu, M.D., Vice Chairman of the Department of Cardiology, Cleveland Clinic, and Patrick McCarthy, M.D., Director of the 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.
About The Direct Flow Medical System
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, which 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 unique 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.
About Direct Flow Medical, Inc.
Founded in 2004, Direct Flow Medical, Inc. is focused on developing novel transcatheter heart valve technologies that improve patient outcomes while reducing patient complications. The company is headquartered in Santa Rosa, California, with technology and manufacturing facilities in Lake Forest, California. The Company's proprietary technology is not limited to aortic valve disease, and is readily applicable to mitral and other heart valve anatomical sites. Direct Flow Medical investors include EDF Ventures, New Leaf Venture Partners, Spray Venture Partners, Foundation Medical Partners, VantagePoint Venture Partners, ePlanet Venture Partners and strategic corporate investors. For further information, please visit the Web site at www.directflowmedical.com.
1Kodali S, Williams M Smith C, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012;366(18):1686-1695.
The Direct Flow Medical Transcatheter Aortic Valve System has not been approved for sale in the USA, Canada, or Japan.
Direct Flow Medical and the Direct Flow logo are trademarks of Direct Flow Medical, Inc.