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Autus Valve Technologies

Boston, Massachusetts, United Statesautusvalve.com ↗

Ownership: Private
Development stage: Preclinical

Overview

The Autus Valve has been successfully implanted in first-in-human procedures and received FDA Breakthrough Device designation in August 2023. It remains investigational and limited to clinical studies. The pivotal study includes pediatric patients aged 18 months to 16 years with severe pulmonary stenosis or regurgitation.

Therapeutic areas: Cardiovascular
Modalities: Devicesynthetic expandable heart valve prosthesis
Industry: Implantable Medical Devices

Partnerships

Clinical partnerships with major U.S. pediatric cardiac centers for pivotal trials; specific institutions include Nationwide Children's Hospital and NewYork-Presbyterian/Columbia University Irving Medical Center

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