FDA CLEARS MATERIALISE MIMICS ENLIGHT FOR CARDIOVASCULAR SURGERY

3D Printing Industry | 6/14/2019 | Beau Jackson
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Belgian 3D printing software company Materialise has received FDA approval for Mimics Enlight, a 3D modeling software for planning cardiovascular surgery.

Bryan Crutchfield, vice president and general manager of Materialise North America, said, “We believe in the power of our mission to create a better and healthier world […] We work very closely with teams at our partner hospitals and medical device companies to identify areas where 3D planning and printing can improve their ability to plan procedures.”

FDA - CLEARANCE - OF - MIMICS - ENLIGHT

“WITH THE FDA CLEARANCE OF MIMICS ENLIGHT, WE ARE EXPANDING THE 3D TOOLKIT FOR CARDIOLOGISTS WORKING TO TREAT PATIENTS WITH COMPLEX CARDIOVASCULAR ISSUES, STARTING WITH MITRAL VALVE REPLACEMENT.”

Mimics Enlight was developed in collaboration with Henry Ford Health System, a Detroit-based healthcare organization established by the American industrialist Henry Ford. The software is specifically used for planning complex transcatheter mitral valve replacement (TMVR) procedure.

Mitral - Valve - Atrium - Ventricle - Heart

Mitral valve is located between the left atrium and left ventricle of the heart. Among several types of mitral valve diseases, it is reported that mitral regurgitation is the most common in developed countries, approximately 10% of the over 75 population suffers from the disease.

Although mitral valve repair or replacement is the best treatment for the disease, patients are not referred for surgery as often by their doctors. This is due to the perceived risk of surgery.

Years - Companies - Devices - Transcatheter - Valve

Over the years, companies have manufactured devices for less invasive transcatheter mitral valve repair treatments. Such devices include MitraClip by California-based Abbott Vascular and Carillon by Cardiac Dimensions in Washington. But even though the devices are available for implantation, performing the surgery remains a formidable challenge.

Mimics Enlight was specifically designed to aid the...
(Excerpt) Read more at: 3D Printing Industry
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