Cardiac Dimensions said today it launched a pivotal trial of the Carillon mitral valve repair device it’s developing, and that it enrolled and randomized its first patient in the trial.
The Kirkland, Wash.-based company’s percutaneous Carillon annuloplasty device is designed to use a distal anchor and proximal anchor, connected by a shaping ribbon, to re-form the mitral annulus by bending the coronary sinus. Late last year the FDA granted an investigational device exemption for a 400-patient pivotal trial of the Carillon device.
The first patient in the trial was enrolled and randomized by Dr. Tomasz Siminiak of Poland’s Poznan University of Medical Sciences, Cardiac Dimensions said.
“We are very excited to participate in this landmark trial to study the Carillon system for patients with FMR. These patients need access to less invasive treatment options, and to be able to contribute to advancements that have the potential to slow the progression of this chronic disease, is very important to us,” Dr. Siminiak said in a prepared statement.
Cardiac Dimensions said it is looking to enroll up to 450 patients to analyze the effectiveness and safety of the Carillon system in treating functional mitral regurgitation as compared to standard-of-care medical treatment following established heart failure guidelines.
The trial has 12-month primary safety and efficacy endpoints and patients will be followed out to five years, the company said. The trial also features a cross-over that will allow patients treated with standard-of-care to receive treatment with the Carillon system at one-year post-procedure.
“Current treatments to improve the quality of life for patients with FMR fall short and many heart failure patients are too frail for open-heart surgery. Transcatheter treatments have been shown to be safe and effective in the treatment of valve diseases, but there is no minimally invasive intervention yet approved in the U.S. for these patients. Today, most FMR patients are treated with medical therapy only for decreasing symptoms but this does not address the underlying anatomical problem leading to mitral regurgitation. The Carillon trial should provide us a better understanding of the benefits of the Carillon system as an option for heart failure patients with FMR,” principal investigator Dr. Samir Kapadia of the Cleveland Clinic said in a prepared statement.
“The initiation of the Carillon trial is the pinnacle of our clinical program, which includes positive data from three previous clinical trials, and is the final step on our path to bringing the Carillon system to patients in the United States. Our vision is to have a significant impact on the treatment of patients with FMR, offering physicians a safe and easy-to-use option that can treat a broader range of patients with the goal of slowing disease progression and preventing worsening quality of life,” prez & CEO Gregory Casciaro said in a press release.
In April, Cardiac Dimensions said that it raised a $39 million Series B round for the Carillon mitral valve repair device it’s developing.
