Restore Medical’s ContraBand device gets FDA’s breakthrough status

Restore Medical has received breakthrough device designation from the FDA for its ContraBand system to treat left ventricle (LV) failure. This system is the first transcatheter pulmonary artery banding (PAB) device aimed at improving patients' quality of life. It targets heart failure patients with reduced ejection fraction (HFrEF) who haven't responded to guideline-directed medical therapy and don't have significant right heart failure or pulmonary hypertension.

The FDA's designation will escalate the development and review of the ContraBand device. Restore Medical highlighted this milestone as critical for addressing unmet needs in HFrEF treatment. The minimally invasive transcatheter PAB system aims to relieve symptoms and improve quality of life for those with LV failure.

Positive results from an ongoing feasibility study have shown the ContraBand’s safety and efficacy, including reduced LV volume, improved hemodynamic function, and increased physical capacity. The catheter-delivered implant supports the LV by leveraging the right ventricle, enhancing ejection fraction, and restoring ventricular geometry.