FDA Breakthrough Device Designation Granted for ...
Alleviant Medical Inc. received FDA Breakthrough Device designation for its no-implant transcatheter technology, aimed at treating heart failure patients with preserved or midrange ejection fraction. The technology creates a therapeutic interatrial shunt to reduce left atrial pressure without a permanent implant, currently under investigational use.
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Alleviant Medical Inc. received FDA Breakthrough Device designation for its no-implant transcatheter technology, aimed at treating heart failure patients with preserved or midrange ejection fraction. The technology creates a therapeutic interatrial shunt to reduce left atrial pressure without a permanent implant, currently under investigational use.
Alleviant Medical Inc. received FDA Breakthrough Device designation for its no-implant interatrial shunt therapy, aimed at treating heart failure patients (HFpEF/HFmrEF) without permanent implants. This designation expedites device development and review, enhancing patient access. The technology offers a minimally-invasive option for patients with limited treatment choices, with clinical evidence development underway.