Designing the first drug-eluting TAVR platform for the entire aortic regurgitation continuum, including infective endocarditis.

Built by the inventors of transcatheter valves for the non-calcified annulus.

TAVR has become the standard of care for aortic stenosis, depending on age, anatomy and surgical risk of the patient. Conventional TAVR systems anchor against the calcified annulus. In aortic regurgitation there is no calcium, so anchoring becomes a major challenge. The first dedicated transcatheter AR valve was recently approved, but one significant AR patient segment, infective endocarditis, still has no transcatheter option.

Standard therapy for infective endocarditis requires four to six weeks of systemic antibiotics, yet falls short: antibiotics alone cannot reverse the aortic valve destruction, and many high-risk patients are denied surgery.

devie medical is developing a drug-eluting TAVR platform designed for exactly this anatomy and pathology. Our founders have built and commercialized structural heart companies before; devie carries that design heritage into a new category.

devie's grippers are designed to engage the native aortic leaflets. As the self-expanding frame expands, the leaflets are secured between the grippers and the stent frame.

Dry pericardial leaflets come pre-loaded on the delivery system: no rinsing, no loading in the cath lab, and a lower target delivery profile.

Securing the infected leaflets between grippers and frame aims to immobilize bacterial vegetations and is designed to prevent embolism.

Bioabsorbable antibiotic films are designed to release high-dose antibiotics directly into the infection, penetrating the biofilm, to increase local drug exposure and complement systemic therapy.