Direct Flow Names Steering Committee and New Co-Principal Investigator for Pivotal Trial

Always one to watch with its innovative Transcatheter Heart Valve, Direct Flow Medical®, Inc., tells us that D. Scott Lim, MD, will be joining the SALUS pivotal trial as national co-principal investigator.

Background

The SALUS Trial is a prospective, randomized, multi-center, core lab-adjudicated U.S. clinical trial, evaluating the Direct Flow Medical Transcatheter Aortic Valve System. The primary endpoint of the trial is a composite of all-cause mortality and disabling stroke at 12 months. Completion of enrollment in the SALUS Trial is expected by the fourth quarter of 2016.

Joining the already incumbent co-principal investigator, Isaac George,  Dr. Lim is an associate professor of medicine and pediatrics for the Advanced Cardiac Valve Center at the University of Virginia (UVA) and medical director of the Bon Secours Virginia Advanced Cardiac Valve Center.

 A luminary in transcatheter aortic valve and mitral valve replacement, Dr. Lim also created and continues to run a humanitarian charity endeavor between UVA and Cedimat hospital in Santo Domingo, Dominican Republic, for the care and education of rheumatic heart disease.

Dr. Lim replaces Murat Tuzcu, MD, of the Cleveland Clinic, who was previously national co-principal investigator representing interventional cardiology for the SALUS Trial. Dr. Tuzcu has accepted a position running the Cleveland Clinic program in Abu Dhabi.

The company has also named the Steering Committee for the SALUS Trial, which will be responsible for advising the investigators and guiding the trial

Investigator comments

“Direct Flow Medical has developed an ingenious device that improves upon the limitations of current commercial transcatheter valves,” said Dr. Lim. “I am excited to lead the U.S. research into this novel valve along with Dr. Isaac George, and we fully expect for the SALUS study to validate the clinical and real world results showing the virtual elimination of paravalvular leak and excellent survivability with a superior risk profile.”

Company comments

“Dr. Lim is one of the top interventional cardiologists and TAVR researchers in the country, and we are enthusiastic about welcoming him to the esteemed SALUS team,” said Dan LeMaitre, Direct Flow Medical’s chief executive officer. “As we expand the SALUS Trial into high risk patients and move from a single-arm to randomized controlled study for FDA approval, we will benefit from his expertise, and that of our Steering Committee. I also want to thank Dr. Tuzcu for his strong leadership of the SALUS Trial and look forward to continuing to benefit from his guidance as part of the Steering Committee.”

Source: Direct Flow Medical, Inc.

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