Cardiac Dimensions is launching a pivotal study of a device that treats heart failure patients with early-stage functional mitral regurgitation (FMR). The EMPOWER trial will evaluate the Carillon Mitral Contour System and look at about 300 patients at 75 sites.
The Kirkland, WA-based company said the study has primary safety and efficacy endpoints at 12 months and will follow the randomized patients out to five years to document long-term safety and clinical status.
"The launch of our U.S. study represents a significant milestone for the company and big step forward to being able to offer the Carillon therapy to a patient population in need," said Rick Wypych, Cardiac Dimensions President and CEO. "It's interesting that despite just announcing the trial, we are already seeing overwhelming interest from our sites and the physician community, which is a clear testament to the need for additional device therapies for heart failure patients with early-stage FMR."
The company said will it use third-party monitoring, core lab review, and external safety reviews, which will produce the most scientifically rigorous clinical data to date in the investigation of heart failure patients with FMR.
With this milestone, Cardiac Dimensions moves one step closer to competing with two titans in the FMR space – Abbott Laboratories and Edwards Lifesciences.
Abbott won a nod from FDA in 2019 for the MitraClip to treat the FMR population. The MitraClip received FDA approval for the treatment of primary functional regurgitation in 2013. The firm inherited the MitraClip through the acquisition of Evalve in 2009.
Irvine, CA-based Edwards competes in the FMR market with the Cardioband device. Edwards gained access to Cardioband through its $340 million plus milestone payments acquisition of Valtech Cardio Ltd. Cardioband has had CE mark since 2015. The device has not yet secured FDA approval.