Abbott initiates pivotal trial for Cephea™ device, an innovative treatment for mitral heart valve disease
Key Highlights
- ➤Abbott initiates CROWN-MV pivotal trial for investigational Cephea mitral valve system
- ➤CROWN-MV will enroll up to 585 people across the U.S., Canada and Europe
- ➤Cephea targets symptomatic patients ineligible for surgery or transcatheter repair
- ➤30-day Cephea early feasibility results will be presented at TCT 2026
Expert Statements
Juan F. Granada, President and chief executive officer of the Cardiovascular Research Foundation and CROWN-MV trial chair
“Patients with severe symptomatic mitral valve disease often cannot undergo conventional surgery or transcatheter mitral valve repair, and therapeutic options for these patients have been extremely limited.”
Juan F. Granada, President and chief executive officer of the Cardiovascular Research Foundation and CROWN-MV trial chair
“The initiation of the CROWN-MV trial represents an important step forward in bringing a dedicated single-step catheter-based replacement option to clinical practice for these high-risk patients.”
Juan F. Granada, President and chief executive officer of the Cardiovascular Research Foundation and CROWN-MV trial chair
“Designed to treat complex mitral anatomies, Cephea has the potential to address a significant unmet patient need.”
Sandra Lesenfants, Senior vice president of Abbott's structural heart business
“With Abbott's first-of-its-kind MitraClip, we were pioneers in offering a minimally invasive therapy to treat mitral regurgitation.”
Sandra Lesenfants, Senior vice president of Abbott's structural heart business
“Building on more than two decades of mitral valve leadership, Cephea is one example of how Abbott continues to innovate to address the diverse needs of patients with mitral valve disease.”
Sandra Lesenfants, Senior vice president of Abbott's structural heart business
“Early clinical experience with Cephea and the launch of the CROWN-MV pivotal trial underscore the potential of this technology and move us closer to understanding how it may benefit patients with mitral valve disease.”
Abbott initiates pivotal trial for Cephea™ device, an innovative treatment for mitral heart valve disease PR Newswire
* CROWN-MV trial will evaluate the safety and effectiveness of investigational Cephea mitral valve replacement device * Abbott's Cephea is designed to provide a new, minimally invasive option for treating mitral valve disease, the most common type of heart valve ailment * 30-day early feasibility study results for Cephea will be presented at TCT 2026 ABBOTT PARK, Ill., Oct. 29, 2026 /PRNewswire/ -- Abbott (NYSE: ABT), the global healthcare leader, announced today it has initiated the CROWN-MV pivotal trial evaluating the safety and effectiveness of its investigational Cephea™ Mitral Valve System in treating people with symptomatic mitral valve disease who are not candidates for surgery and transcatheter repair. The first enrollment in the CROWN-MV study occurred at Ascension Via Christi Hospital in Wichita, Kan., led by Bassem Chehab, M.D.
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