Restore Medical has secured the US Food and Drug Administration’s (FDA) breakthrough device designation for its ContraBand system to treat left ventricle (LV) failure.

The device is claimed to be the first transcatheter pulmonary artery banding (PAB) system in the world intended to improve the patient’s quality of life.

It is designed to treat patients with heart failure with reduced ejection fraction (HFrEF) who have not responded to tolerated guideline-directed medical therapy, with no significant right heart failure or pulmonary hypertension.

The FDA’s designation is expected to accelerate the development and review process of the ContraBand device.

In a press statement, Restore Medical said: “This designation marks a significant milestone in the company's mission towards the 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.”

The system offers a minimally invasive transcatheter PAB approach. It is intended to alleviate symptoms and enhance the quality of life for patients suffering from left ventricular failure.

The FDA's decision is based on positive results from an ongoing feasibility study, which demonstrated the ContraBand’s promising outcomes in terms of safety and efficacy.

This study has shown encouraging results, including a reduction in left ventricular volume, improved haemodynamic function, and increased physical capacity in treated patients.

The catheter-delivered ContraBand implant can support the LV by leveraging the right ventricle (RV), enhancing LV ejection fraction and restoring optimal ventricular geometry.

ContraBand’s implantation procedure is said to be simple and time-effective.