Mitral Regurgitation
There are an estimated 6M individuals who experience MR in the U.S. and these numbers are expected to grow as the population ages. Due to the complexity of surgery within the invasive open-heart setting, only 0.4% of individuals with MR receive surgical intervention to repair this condition, which indicates a very large unmet need for care. Medical therapy cannot treat degenerative MR.
There are approximately 2,500 physicians in the U.S. that perform this type of surgery. Of this number, approximately 10 key physicians perform roughly 15% of the surgeries. The mitral valve is replaced in half of the MR surgical cases, notwithstanding that studies show that repair is superior to replacement, and roughly 90% of MR surgical cases are candidates for repair.
The MR patents protect technology surrounding artificial chords of predetermined lengths used to repair the mitral valve chordae during MR surgical procedures. The chord can be accompanied by a ring device and procedure for MR surgical procedures, also patented.
Benefits include but are not limited to endoscopic approach, repair versus replacement, access to varying chord lengths and reduction in cross-clamp time (lower infection, fewer complications, less bleeding). All of these benefits inure to the patient in shorter length of hospital stay, smaller incision, and faster mobilization and return to lifestyle.
Progress to date has been made in the following areas:
- 60-Day Pilot Study showed excellent tissue integration and exceptional mitral valve function
- Performance Testing and Engineering Benchmarking for tensile strength, suture knot pull test, sheath deployment force, and other measurements of durability
- Biocompatibility testing
- Preclinical animal (ovine) testing
- Correspondence with FDA relating to traditional 510K clearance
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