Restore Medical Announces Successful First-In-Human Preliminary Results of Its CONTRABAND™ System for Symptomatic Systolic Heart Failure Patients
07 Mar 2023
AHAClinical StudyClinical Result
OR YEHUDA, Israel, March 7, 2023 /PRNewswire/ -- Restore Medical Ltd, a privately held medical device company, has successfully completed enrollment of the First In Human clinical study with its CONTRABAND™ device. The world's first and only Pulmonary Artery Banding (PAB) transcatheter implant 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.
About the CONTRABAND™ device
The innovative catheter-delivered implant, CONTRABAND™, is designed to treat left ventricle (LV) failure by deploying implants in the left and right pulmonary arteries. This enables the preserved right ventricle (RV) to assist the failing LV, improving LV ejection fraction and restoring favorable ventricular geometry. Currently, there are no approved device treatments for this indication, positioning Restore Medical's technology to transform the way CHF patients are treated.
About Restore Medical Ltd.
Restore Medical Ltd is a privately held company dedicated to revolutionizing the treatment of heart failure with a novel, world's first PAB treatment. The company is backed by Peregrine Ventures, Horizon Europe, and an undisclosed strategic investor. For more information, please visit .
Contact Details:
Gilad Marom, gilad@restoremedical.co
T: +972523771360
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