Restore Medical has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for its ContraBand device.
The designation is specifically for treatment of heart failure with reduced ejection fraction (HFrEF) patients who remain symptomatic despite maximally tolerated guideline-directed medical therapy, without significant pulmonary hypertension or right heart failure.
FDA’s breakthrough device designation programme is intended to expedite the development and review of medical devices that offer significant advantages over existing treatments for serious or life-threatening conditions.
In a press release, Restore Medical said that the designation marks a significant milestone in the company’s mission towards improvement of cardiac care for heart failure patients as it highlights the potential of the ContraBand device to address critical unmet needs in the treatment of HFrEF patients.
ContraBand is a transcatheter pulmonary artery banding (PAB) system designed specifically for HFrEF patients with the aim of improving the quality of life for these patients. This minimally invasive procedure offers hope to patients suffering from left ventricle failure who currently have limited treatment options, the company’s press release adds.
FDA’s decision to grant breakthrough device designation was based on results from an ongoing feasibility study demonstrating promising outcomes in safety and efficacy. These results include significant left ventricular volume reduction, improved haemodynamic function, and enhanced physical capacity in patients treated with the ContraBand device.
