Dr. Marvin Slepian Gives Keynote Speech on SynCardia’s Total Artificial Heart at Medical Devices Summit 2010
SynCardia Chairman Addresses Winning FDA Approval and Medicare Reimbursementfor the World’s Only Approved Total Artificial Heart
TUCSON, Ariz. – March 2, 2010 – On March 2, Dr. Marvin Slepian, world-renowned interventional cardiologist and co-founder and chairman of SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, was the keynote speaker at the Medical Devices Summit 2010 held in Boston. The conference highlighted key strategies for regulatory compliance, including the latest tips for streamlining the medical device approval process.
“In 2004, SynCardia’s Total Artificial Heart became the first and only Total Artificial Heart in the world to receive Pre-Market Approval from the FDA,” said Dr. Slepian. “In 2008, SynCardia also successfully petitioned the Centers for Medicare & Medicaid Services to reverse its 1986 national non-coverage policy for artificial hearts and approve reimbursement through the highest paying Diagnostic Related Group codes.”
In addition to discussing the development and clinical use of the Total Artificial Heart, Dr. Slepian also addressed the future of SynCardia technologies currently under development, including its new family of pneumatic drivers for powering the Total Artificial Heart and the smaller 50cc Total Artificial Heart designed for women and patients of smaller stature.
Dr. Slepian is Professor of Medicine (Cardiology), Director of Interventional Cardiology and Director of the Tissue Engineering Lab at the University of Arizona. He has founded numerous medical device companies and has served as acting CEO and Board Member of several medical device startups. Additionally, Dr. Slepian has conducted extensive research, development and pre-clinical investigation of novel cardiovascular therapeutic methods and devices.
About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the SynCardia Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.
Janelle Drumwright, firstname.lastname@example.org, (520) 547-7463