Mitral regurgitation (MR) occurs when the mitral valve leaflets do not close properly, resulting in a leakage of blood backward through the mitral valve. With acute severe mitral valve regurgitation, open-heart surgery is considered the standard gold treatment to either repair or replace the diseased valve, depending on the condition's cause. In Europe and the US, approximately 13 million people have been diagnosed with MR. However, today, less than 5% of patients with moderate to severe disease receive treatment. However, untreated valve incompetency results in volume overload and backward failure, affecting lung function and continuing to right heart failure and, subsequently, organ failure and death.
AVVie is developing the Mitral Butterfly (MB) system, a novel, innovative solution for patients suffering from MR and subsequent heart failure. The Mitral Butterfly is a hemi valve replacing the function of the native, dysfunctioning posterior leaflet. The Mitral Butterfly restores full coaptation with a nitinol-based frame and a pericardial membrane by sliding over the diseased leaflet while preserving the motion and function of the anterior leaflet. The Mitral Butterfly has been designed to have a stable atraumatic implant seating without penetration of the myocardium, preventing unphysiological inflow (regurgitation) caused by diverse pathophysiologic origins like DMR and FMR and minimizing the outflow obstruction (stenosis) with low artificial footprint. The delivery can be done by both minimally invasive surgery and by transseptal delivery.
While today, surgical repair and/or replacement is considered first-line therapy for patients with severe MR, many patients are inoperable. Today, Mitral Transcatheter Edge-to-Edge Repair (M-TEER) and Transcatheter Mitral Valve Replacement (TMVR) offer an alternative to some of the inoperable patients. Nevertheless, due to the high screen failure rates of up to 90% and suboptimal outcomes there is a further need for innovative mitral repair options for patients in need.
Within the EIC Accelerator program, AVVie integrates an innovation loop to standardize testing and iterate the best available implant based on anatomy and pathophysiology. Building a digital twin for preprocedural planning and facilitating implantation and navigation is part of the success. The ease of use is shown in our schematic and its integration into the anatomy, targeting a successful repair using the Hemi Valve Mitral Butterfly. Unlike competitors, as seen in the schematic, our Mitral Butterfly device follows the anatomic and pathophysiologic assumptions for a successful repair. Acceleration using the EIC Fund allows us to show that AVVie is more than a mitral repair option by integrating imaging for navigation, preprocedural planning, and new concepts for manufacturing.
