Direct Flow Medical has appointed D Scott Lim as national co-principal investigator for the SALUS pivotal trial. Lim is currently a medical director of the Bon Secours Virginia Advanced Cardiac Valve Center, and is an associate professor of medicine and paediatrics for the Advanced Cardiac Valve Center at the University Of Virginia, USA. He joins co-principal investigator Isaac George, surgical director of transcatheter therapies for the Columbia Heart Valve Center at Columbia University Medical Center.
According to Direct Medical Flow, Lim has expertise in novel percutaneous approaches to heart valve disease. His research has focused on transcatheter aortic valve and mitral valve replacement. He also heads a charity, Endeavor, between the University of Virginia and Cedimat hospital in Santo Domingo, Dominican Republic, promoting the treatment and education of rheumatic heart disease. Lim was also the first ever proctor of the MitraClip procedure.
Lim replaces Murat Tuzcu, of the Cleveland Clinic, who was previously national co-principal investigator representing interventional cardiology for the SALUS Trial. Tuzcu has accepted a position running the Cleveland Clinic program in Abu Dhabi.
“I am excited to lead the US research into this novel valve along with 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,” says Lim.
The SALUS Trial is a prospective, randomised, multi-centre, core lab-adjudicated US 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 enrolment in the SALUS Trial is expected by the fourth quarter of 2016.
The company has also named the Steering Committee for the SALUS Trial, which will be responsible for advising the investigators and guiding the trial:
- Isaac George, Columbia University Medical Center, New York, USA – *Co-principal investigator
- D. Scott Lim, University of Virginia/Bon Secours, USA – *Co-principal investigator
- Federico De Marco, Policlinico San Donato, Milan, Italy
- G. Chad Hughes, Duke University Medical Center, Raleigh, USA
- Samir Kapadia, Cleveland Clinic, Cleveland, USA
- Azeem Latib, San Raffaele, Milan, Italy
- Mubashir Muntaz, Pinnacle Health System, Harrisburg, USA
- Christoph Naber, Contilia Heart and Vascular Center, Essen, Germany
- Jeff Popma, Beth Israel Deaconess Medical Center, Boston, USA
- Vivek Rajagopal, Piedmont Heart Institute, Atlanta, USA
- Michael Reardon, Houston Methodist, Houston, USA
- Newell Robinson, St. Francis Hospital, New York, USA
- E. Murat Tuzcu, Cleveland Clinic, Cleveland, USA
“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 randomised controlled study for FDA approval, we will benefit from his expertise, and that of our Steering Committee. I also want to thank 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.”
The Direct Flow Medical system received the CE mark in January 2013 for the treatment of patients with aortic stenosis who are at extreme surgical risk and is commercially available in Europe.