Restore Medical has achieved a significant milestone with the FDA granting Breakthrough Device designation to its ContraBand system for treating heart failure with reduced ejection fraction (HFrEF). This designation highlights the potential of ContraBand to address critical unmet needs in HFrEF patients who remain symptomatic despite maximally tolerated guideline-directed medical therapy (GDMT), and who don’t have significant pulmonary hypertension or right HF.
Innovative Approach to Heart Failure Treatment
The ContraBand device is a novel, reversible therapy designed to support the left ventricle (LV) by leveraging the right ventricle (RV). Implanted via a minimally invasive transcatheter procedure, this pulmonary artery banding (PAB) system aims to improve LV ejection fraction and restore optimal ventricular geometry. The device offers a new option for patients with left ventricle failure who currently have limited treatment possibilities.
Clinical Evidence and Outcomes
The FDA's decision was based on promising results from an ongoing feasibility study, which demonstrated significant improvements in safety and efficacy. Key findings include:
- Significant reduction in left ventricular volume.
- Improved hemodynamic function.
- Enhanced physical capacity in patients treated with the ContraBand device.
In a first-in-human study of 15 heart failure patients already on GDMT, all participants experienced improved symptoms, including improvements in left ventricle ejection fraction, following treatment.
Addressing an Unmet Need
Currently, no approved treatments exist that specifically target this condition, meaning ContraBand could potentially transform the way congestive heart failure patients are treated. Congestive heart failure affects over 6 million Americans and is a leading cause of mortality, with less than half of patients living beyond 5 years after diagnosis. High hospital readmission rates, with approximately 25% of patients returning within a month of discharge, further underscore the urgent need for innovative therapies.
Financial Support and Future Directions
Restore Medical received substantial financial backing from the European Innovation Council (EIC), including a €2.5 million grant and a potential €10 million equity investment, to advance the clinical development of the ContraBand device and further investigate its safety and efficacy. The ongoing research and development efforts aim to solidify the device's role in improving cardiac care for heart failure patients.
