Restore Medical made headway in its bid to obtain regulatory approval for heart failure treatment. The Or Yehuda, Israel-based company said it has completed enrollment of the first in human clinical study of its device, which is named Contraband.
Restore is touting the device as the first and only pulmonary artery banding (PAB) transcatheter implant that is designed to treat heart failure with reduced ejection fraction.
The feasibility, multi-center, prospective study enrolled 15 patients who were already on maximally tolerated guideline-directed medical therapy (GDMT) across 5 hospitals in Europe. All treated patients experienced symptom improvement, leading to the expansion of the clinical program.
The six-month and one-year results of the study demonstrated that the Contraband device improved the quality of life of the treated patients, as demonstrated by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and six-minute walk test (6MWT), and led to a reduction in the New York Heart Association (NYHA) heart class and improvement of left ventricle ejection fraction (LVEF). The company said the implantation procedure was safe for all participants, with excellent long-term right ventricular safety.
