Materialise’s Cardio Planning Software Cleared

June 14, 2019

The FDA granted Materialise 510(k) clearance for its Mimics Enlight product, a suite of cardiovascular planning software that create 3D models for use in transcatheter mitral valve replacement (TMVR) procedures.

The device provides clinicians with accurate 3D models for consistent patient for TMVR therapy screening. It also helps clinicians to determine the appropriate size and placement of TMVR devices.

The 3D models improve physicians’ ability to “understand and plan procedures before entering the cath lab and gives them the reliable measurements critical to successful implantation of TMVR devices in highly diseased hearts,” said Brigitte de Vet-Veithen, vice president of Materialise.

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