FDA Clears Heart Valve Software Developed at Henry Ford

June 13, 2019
Wang DeeDee


First-of-its-kind Planning Tool Aids Mitral Valve Procedure

DETROIT – The U.S. Food and Drug Administration has cleared the use of novel computer software developed at Henry Ford Health System to aid cardiologists performing mitral valve procedures.

Dr. Dee Dee Wang, Director of Structural Heart Imaging for the Henry Ford Center for Structural Heart Disease, was instrumental in developing the software. The Mimics Enlight cardiovascular planning software suite provides measuring tools used to evaluate patients and plan complex transcatheter mitral valve replacement (TMVR), or replacement of a patient’s failing mitral valve.

A pioneer in cardiac imaging, Dr. Wang has developed the technology in conjunction with Henry Ford Innovations and experts at Belgium-based Materialise, a 3D printing software and solutions company with branches worldwide, including Plymouth, Mich.

“We’re excited that physicians around the world will have access to this tool that we have at Henry Ford to prevent complications during the procedure,” Dr. Wang said. “This will save patient’s lives.”

The software evaluates the patient’s anatomy inside the heart to avoid the risky complication called ‘Left Ventricular Outflow Track’ (LVOT) obstruction, a lethal blockage of blood flow from the left ventricle once a new mitral valve is put in place.

“Our hope is physicians around the world will find it useful and will have more confidence – and a higher safety margin -- performing these high-risk procedures with this tool kit,” Dr. Wang said.

The Mimics Enlight software is based on a patent issued in July 2017 to Henry Ford Health System. The patent and recent FDA approval are the result of more than five years of work by Dr. Wang in conjunction with Henry Ford Innovations and Materialise.

Under a licensing agreement between Materialise and Henry Ford Health System, the 3D software company is the exclusive commercial agent for the proprietary methods and its underlying intellectual property.

“Anytime we are able to use innovation to advance care for our patients, that’s a win, and we’re proud to do it in partnership with a cutting-edge company like Materialise,” said Mark Coticchia, Vice President & Chief Innovation Officer of Henry Ford Health System. “The 3D modeling developed by Dr. Wang, Materialise and Henry Ford Innovations is a great example of cutting-edge, precision medicine practiced here at Henry Ford.”

World-renowned cardiologist Dr. William W. O’Neill, Medical Director of Henry Ford Health System’s Center for Structural Heart Disease, said this is one more way the Henry Ford Heart & Vascular Institute is leading the way in advanced cardiac care. “Dr. Wang’s expertise has improved the care cardiologists can provide to their patients,” said Dr. O’Neill, who pioneered the use of heart stents during heart attack. “That’s an invaluable contribution, and we’re very proud of the work done at Henry Ford.”

About Henry Ford Health System

Henry Ford Health System is a six-hospital system headquartered in Detroit, Michigan. It is one of the nation's leading comprehensive, integrated health systems, recognized for clinical excellence and innovation. Henry Ford Health System provides both health insurance and health care delivery, including acute, specialty, primary and preventive care services backed by excellence in research and education. Henry Ford Health System is led by President & CEO Wright Lassiter III. Visit HenryFord.com to learn more.

About Henry Ford Innovations

Established in 2011, Henry Ford Innovations engineers the future of healthcare through identifying and commercializing the health system's technologies and know-how. Its main arms include Research and Education, Technology Management, Corporate Innovation, and International Programs. To learn more, visit HenryFord.com/About/Innovations.

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