Actively enrollingContraBand™ Safety & Feasibility StudyFirst-in-human, multicenter, single-arm safety and feasibility study. More than 30 patients, mean follow-up 30 months (longest beyond 48 months).ContraBand™ study
Planned, subject to FDA approvalRESTORE-HF pilot study (US and Europe)Prospective, randomized, sham-controlled, double-blind pilot study. Procedures are planned at sites in the United States and Europe.RESTORE-HF study
FDA Breakthrough Device Designation received. The designation relates to the treatment of patients with heart failure with reduced ejection fraction (HFrEF). Announcement