Medtronic has today announced a partnership with The Foundry—a medical device company incubator—to invest in and create a company with the goal of developing an innovative transcatheter mitral repair (TMVr) technology.
The arrangement provides for structured investment tranches from both Medtronic and The Foundry and includes an exclusive right for Medtronic to acquire the resulting company, Half Moon Medical, contingent upon the achievement of certain technical and clinical milestones.
Half Moon recently received US Food and Drug Administration (FDA) approval of an early feasibility study in patients with severe, symptomatic mitral regurgitation and expects first implants in the coming weeks.
“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,” said Nina Goodheart, president of the Coronary & Structural Heart division, which is part of the Cardiac and Vascular Group at Medtronic. “We believe this technology is promising and differentiated from other approaches to mitral valve repair.”
Half Moon Medical’s TMVr device restores function in a diseased mitral valve by filling the regurgitant orifice, creating a new coaptation surface for the native anterior leaflet. The device is fully repositionable and recoverable during deployment using a transfemoral delivery catheter, which assists physicians in navigating the vasculature and delivering the device to the diseased native mitral valve.
“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 aetiologies,” said Hanson Gifford, president and CEO, 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.”
The Half Moon device has the potential to complement Medtronic’s pioneering Intrepid Transcatheter Valve Replacement System, a minimally invasive mitral valve replacement device currently being studied in the APOLLO Pivotal Trial, the first pivotal trial approved by the US FDA for Transcatheter Mitral Valve Replacement (TMVR). Additionally, Medtronic is enrolling early feasibility studies of the Intrepid Transfemoral System, designed to evaluate transseptal/transfemoral access of the Intrepid system in patients with either severe, symptomatic mitral or tricuspid valve regurgitation.