The percutaneous approach

Mitral Regurgitation is the third most common cardiovascular disease that occurs when there is backward flow of blood across the mitral valve. It is highly prevalent, debilitating for patients, and deadly if untreated. The market is expected to be larger than the TAVR market, currently a $6B market.

The CardioMech device is an artificial chord that is designed to reduce or eliminate regurgitation and to restore the native anatomy. This catheter-based therapy is intended to be a simple and straightforward procedure and an alternative therapy option for both patients eligible for open-heart surgery and those considered surgically ineligible. Therefore, the CardioMech device can potentially reduce the need for open-heart surgery and may lessen the need for watchful waiting in younger and healthier patients.

The CardioMech MVRS is a transcatheter mitral valve repair solution designed to address key limitations in the current standard of care options for this patient population:

- Less-invasive access route preferred by patients: transfemoral, transseptal delivery of artificial chord(s) to replace broken or elongated native chordae tendinea.
- Designed for a simple and straightforward procedure:
    - Potentially one-chord, sub-hour procedures for the treating simple DMR cases
    - Ability to deploy up to two chords for more complex DMR cases
- No cardiac arrest: implant artificial chord(s) on a beating heart with echocardiographic guidance 
- Preserves therapy options for the patient: due to small implant size, future therapy options may be preserved for the patient, including cardiac surgery (both repair and replacement) or alternative transcatheter technologies

These key design objectives create the potential for the CardioMech MVRS to be first-line therapy for DMR patients.
Information on the CardioMech MVRS Early Feasibility Study is available on clinicaltrials.gov. 

The CardioMech MVRS is for investigational use only and is not available for sale in any geography.

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