Dr. Marvin Slepian Gives Keynote Speech on SynCardia’s Total Artificial Heart at Medical Devices Summit 2010

TUCSON, Ariz.--(BUSINESS WIRE)--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 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 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, and is the holder of more than 25 issued and 41 filed patents.

About SynCardia Systems, Inc.

SynCardia Systems, Inc. is the Tucson-based manufacturer of the world’s only FDA, Health Canada and CE approved Total Artificial Heart: the SynCardia temporary CardioWest™ Total Artificial Heart. There have been more than 800 implants of the Total Artificial Heart, accounting for more than 180 patient years of life on the device.

Originally used as a permanent replacement heart, the Total Artificial Heart is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.

For additional information, please visit: http://www.syncardia.com
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