HighLife SAS has announced that that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its transseptal mitral valve replacement (TMVR) system to treat patients suffering from moderate to severe mitral regurgitation (MR).
The FDA’s breakthrough device programme is designed to speed up the development and review of devices that offer substantial improvement over current treatments or diagnostics for serious conditions and address unmet medical needs. The designation provides companies with access to more frequent interactions with the FDA, facilitating a faster path to approval and the potential for earlier access to innovative medical devices for patients and healthcare providers.
Stefan Pilz, chief executive officer of HighLife, said: “We are honoured to receive the breakthrough device designation by the FDA. HighLife has made significant clinical progress and is addressing a huge unmet clinical need. This designation recognises the potential of HighLife to become the standard of care in mitral regurgitation treatment once FDA approved and deployed.”
The HighLife technology is under investigation in clinical studies in Europe, Asia-Pacific and the USA. The company received an investigational device exemption (IDE) approval from the FDA to initiate a US Pivotal study.
