A Medical Device Daily
Bioheart (Sunrise, Florida) reported that final data was presented during the late-breaking clinical trial sessions at the annual meeting of the American College of Cardiology, suggesting that MyoCell myoblast clinical cell therapy is a safe and potentially effective alternative treatment to standard medical therapy alone for improving heart function among patients with previously implanted cardiac devices who are experiencing congestive heart failure.
The findings from the SEISMIC(1) Trial, a 40-patient, randomized, multicenter, controlled, Phase II-a study conducted in Europe, evaluated MyoCell myoblast clinical cell therapy delivered via the MyoCath, endoventricular needle-injection catheter in patients previously fitted with implanted cardiac defibrillators(ICDs), receiving standard medical therapy and who are experiencing congestive heart failure.
Patients were randomized 2-to-1 into the treatment vs. control groups: 26 patients receiving MyoCell therapy, 14 patients in the control. All patients were experiencing congestive heart failure and were previously fitted with ICDs and receiving standard medical therapy. Both the MyoCell biologic therapy and the MyoCath needle-injection catheter, developed by Bioheart, are currently being studied as investigational products.
Patrick Serruys, MD, PhD, principal investigator and chief, Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center (Rotterdam, the Netherlands), called the trial results "encouraging while the study was specifically designed to show safety, the findings also suggest positive trends in clinical benefits when evaluating the treated group versus the control group at six months."
"These data support the need for a randomized, double-blind, placebo-controlled study involving the MyoCell technology," said Serruys. "We look forward to applying our learning from this trial to the larger, more comprehensive MARVEL(2) Trial currently underway in the U.S. and Europe."
In other news from the ACC: Percutaneous mitral repair using the MitraClip device may successfully reduce mitral regurgitation (MR) in patients suffering from functional MR (FMR) over a two-year period, according to preliminary data from the ongoing Endovascular Valve Edge-to-Edge REpair STudy (EVEREST) presented at the SCAI Annual Scientific Sessions in Partnership with the ACC i2 Summit.
The EVEREST trial is evaluating the safety/efficacy of the MitraClip, made by Evalve (Menlo Park, California), for the treatment of MR, which causes blood to leak backward through the mitral valve, requiring the heart to work harder and leading to heart failure.
Data analysis was based on 23 patients with moderate-to-severe or severe FMR (grade 3+ to 4+).
James Hermiller, MD, director of the interventional fellowship program at St. Vincent Heart Center of Indiana (Indianapolis), reported that 83% of the 23 FMR patients had successful MR reduction after the MitraClip procedure. The majority (74%) of successfully treated FMR patients showed MR reduction to less than or equal to 2+ MR, and reduction was maintained, with a Kaplan-Meier durability of MR reduction in 89% of patients at one and two years.