Global Finance News
01 Nov 2026, 11:41
Abbott Launches Pivotal Trial for Cephea Mitral Valve Replacement System
Abbott (NYSE: ABT) has initiated the CROWN-MV pivotal trial evaluating its investigational Cephea Mitral Valve System, a minimally invasive transcatheter replacement therapy for patients with symptomatic mitral valve disease who are not candidates for surgery or transcatheter repair.
The global prospective study will enroll up to 585 patients across the U.S., Canada and Europe. It will evaluate patients with moderate-to-severe or severe mitral regurgitation, as well as mitral valve dysfunction associated with mitral annular calcification.
Cephea is delivered through a catheter inserted through a vein in the leg and guided to the heart, where a bioprosthetic valve is implanted inside the diseased mitral valve. The system is designed to expand Abbott’s existing mitral valve portfolio, which already includes MitraClip and the Tendyne transcatheter mitral valve replacement system.
The pivotal trial follows encouraging early clinical development. Abbott said 30-day results from an early feasibility study using its third-generation Cephea delivery system will be presented at the TCT 2026 scientific meeting, with data expected to address mitral regurgitation reduction and quality-of-life outcomes.
The trial represents an important regulatory and commercial development milestone for Abbott’s structural heart business. If successful, Cephea could broaden treatment options for high-risk patients with complex mitral valve anatomy who currently have limited alternatives.
Abbott also plans to present additional TCT 2026 data across several cardiovascular platforms, including Amulet 360, SonicForce, Encantor, Amplatzer Paraclose and Navitor, reinforcing the breadth of its structural heart and cardiovascular pipeline.
Abbott (NYSE: ABT) has initiated the CROWN-MV pivotal trial evaluating its investigational Cephea Mitral Valve System, a minimally invasive transcatheter replacement therapy for patients with symptomatic mitral valve disease who are not candidates for surgery or transcatheter repair.
The global prospective study will enroll up to 585 patients across the U.S., Canada and Europe. It will evaluate patients with moderate-to-severe or severe mitral regurgitation, as well as mitral valve dysfunction associated with mitral annular calcification.
Cephea is delivered through a catheter inserted through a vein in the leg and guided to the heart, where a bioprosthetic valve is implanted inside the diseased mitral valve. The system is designed to expand Abbott’s existing mitral valve portfolio, which already includes MitraClip and the Tendyne transcatheter mitral valve replacement system.
The pivotal trial follows encouraging early clinical development. Abbott said 30-day results from an early feasibility study using its third-generation Cephea delivery system will be presented at the TCT 2026 scientific meeting, with data expected to address mitral regurgitation reduction and quality-of-life outcomes.
The trial represents an important regulatory and commercial development milestone for Abbott’s structural heart business. If successful, Cephea could broaden treatment options for high-risk patients with complex mitral valve anatomy who currently have limited alternatives.
Abbott also plans to present additional TCT 2026 data across several cardiovascular platforms, including Amulet 360, SonicForce, Encantor, Amplatzer Paraclose and Navitor, reinforcing the breadth of its structural heart and cardiovascular pipeline.
