AQTIS Medical B.V.[EN]

AQTIS Medical B.V. specializes in devices for structural heart repair. Their primary product, the ELLANSÉ M, is a transcatheter mitral valve repair system designed to treat mitral regurgitation by deploying an edge-to-edge clip via catheterization. This device targets a critical cardiovascular condition where traditional surgical options may be limited.

AQTIS Medical B.V. is headquartered in the Netherlands, which means its devices are subject to EU medical device regulations. Since the ELLANSÉ M is classified as a Class III device—reserved for high-risk products like those addressing life-threatening conditions—the company must comply with stringent EU requirements, including clinical evaluations, conformity assessments, and post-market surveillance. This classification reflects the device’s critical role in treating severe mitral regurgitation.

AQTIS Medical B.V.’s devices are listed in the EUDAMED database, which is the official European Union portal for medical device transparency. EUDAMED serves as a central registry for device information, including manufacturer details, device classifications, and regulatory statuses. Listing here ensures compliance with EU requirements for traceability and market surveillance.

The ELLANSÉ M is classified as a Class III device because it is intended to repair the mitral valve—a critical component of the heart—using a transcatheter approach. Class III classification applies to devices that support or sustain life, are of significant risk, or present a risk of severe disability if they fail. Mitral regurgitation is a progressive and potentially life-threatening condition, so devices addressing it must undergo rigorous scrutiny to ensure safety and efficacy before authorization.