WEDNESDAY, June 24 (HealthDay News) -- A novel coronary sinus mitral repair implant device -- PTMA® -- is feasible and safe in patients with functional mitral regurgitation, according to a study published online June 23 in Circulation: Cardiovascular Interventions.
Stefan Sack, M.D., of the West German Heart Center in Essen, and colleagues performed a diagnostic PTMA® procedure on 19 patients, which was effective in 13 patients. They implanted the device in nine patients, four of which required device removal due to device migration or diminished efficacy.
After three months, the researchers observed sustained reductions of mitral annulus septal-lateral dimension from 3D echo reconstruction dimensions (median, 4.0 mm).
"The initial safety results are acceptable," the authors conclude. "The magnitude of treatment effect observed in implanted patients likely must be increased to provide a significant clinical benefit for a meaningful subgroup of patients. This experience warrants further investigation to optimize treatment effect and elucidate the clinical impact on patients with functional mitral regurgitation."
The study was funded by Viacor Inc.; several authors reported financial relationships with Viacor.
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