DUBLIN—Medtronic plc has announced a partnership with The Foundry to invest in and create a company with the goal of developing new transcatheter mitral repair technology (TMVr).
The partnership combines Medtronic’s intellectual property with The Foundry’s track record of innovation in the field of transcatheter mitral valve repair and replacement. The arrangement has provided for structured investment tranches from both Medtronic and The Foundry, as well as including an exclusive right for Medtronic to acquire the resulting company — Half Moon Medical — contingent upon the achievement of certain technical and clinical milestones.
“We have been encouraged by Half Moon’s development to date, leveraging Medtronic’s investment and intellectual property coupled with decades of mitral valve therapy experience at The Foundry through their development of repair and replacement technologies, including the Medtronic Intrepid valve. We believe this technology is promising and differentiated from other approaches to mitral valve repair,” said Nina Goodheart, president of the Coronary & Structural Heart division, part of the Cardiac and Vascular Group at Medtronic.
Half Moon Medical’s TMVr device restores function in a diseased mitral valve by filling the regurgitant orifice, which creates a new coaptation surface for the native anterior leaflet. The device is fully repositionable and recoverable during deployment, using a transfemoral delivery catheter.
“The result of testing more than 30 early concepts and design iterations, the Half Moon mitral repair device is a truly innovative solution that is designed to address multiple mitral regurgitation etiologies,” added Hanson Gifford, president and CEO of The Foundry. “Most importantly, similar to mitral valve replacement, this repair device has the potential to fully eliminate mitral regurgitation. It also maintains the physiologic function of the mitral valve and preserves options for re-intervention.”
Half Moon recently received U.S. Food and Drug Administration approval for an early feasibility study in patients with severe, symptomatic mitral regurgitation. The company expects the first implants to happen in the coming weeks.
The Half Moon device has the potential to complement Medtronic’s Intrepid Transcatheter Valve Replacement System, which is a minimally invasive mitral valve replacement device currently being studied in the APOLLO pivotal trial. Medtronic is also enrolling early feasibility studies of the Intrepid Transfemoral System, which is designed to evaluate transseptal/transfemoral access of the Intrepid system in patients with either severe, symptomatic mitral or tricuspid valve regurgitation.