Restore Medical Announces Successful First-In-Human Preliminary Results of Its CONTRABAND™ System for Symptomatic Systolic Heart Failure Patients
Restore Medical, a privately held medical device company, has successfully completed enrollment of the First In Human clinical study with its CONTRABAND™ device for Symptomatic Systolic Heart Failure Patients. The world’s first and only Pulmonary Artery Banding (PAB) transcatheter implant by Restore Medical is designed to treat heart failure with reduced ejection fraction (HFrEF) and improve the quality of life for heart failure patients.
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 implantation procedure was safe for all participants, with excellent long-term right ventricular safety.
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