Cardiac Dimensions launches pivotal trial for Carillon mitral repair device

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...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Cardiac Dimensions Source Type: news