FDA Grants Breakthrough Device Designation to ContraBand System to Treat HFrEF

Today, the FDA granted a breakthrough device designation to Restore Medical’s ContraBand system, a device used to treat patients with heart failure with reduced ejection fraction (HFrEF) who still have symptoms after undergoing maximally tolerated guideline-directed medical therapy, and who don’t have significant pulmonary hypertension or right HF.

According to a news release from Restore Medical, this designation was based on strong results from an ongoing study showing that the device is safe and effective.¹ These results include a significant reduction in the size of the left ventricle, better heart function, and improved physical ability in patients treated with ContraBand.

“This 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,” the news release said.

ContraBand is a novel and reversible therapy aimed at treating left ventricle (LV) failure, and is the first transcatheter pulmonary artery banding (PAB) system designed specifically for patients with HFrEF.² The device is implanted via catheter and uses the right ventricle (RV) to support the LV, improving LV ejection fraction and helping the heart return to its normal shape. Because there are currently no approved treatments for this condition, ContraBand’s breakthrough device designation could greatly change treatment options for patients with congestive HF.

In March 2023, Restore Medical released positive first-in-human results for the device.³ In a feasibility study with 15 patients from 5 European hospitals, patients were already receiving the best possible guideline-directed medical treatment. However, all 15 patients saw an improvement in their HFrEF symptoms after being treated with the ContraBand device, prompting the expansion of the clinical program.

Results at 6 months and 1 year showed the device significantly improved patients' quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire and the 6-minute walk test. Patients also experienced a reduction in the severity of their HF—as indicated by the New York Heart Association class—and an improvement in LVEF. The procedure was safe for all participants, with no long-term issues affecting the right side of the heart. Research is still ongoing at the time of the breakthrough designation.

Two years ago, Restore Medical received significant financial support from the European Innovation Council (EIC) to advance its cardiac implant technology for treating congestive HF.⁴ The company was awarded a €2.5 million grant and a potential €10 million equity investment subject to future milestones at the time. These funds went toward enhancing the clinical development of the ContraBand device and further investigating its safety and efficacy. At the time of the start of the study, the company had already raised $9 million and was 1 of 74 winners selected out of 1093 applicants for EIC funding in March 2022.

Congestive HF affects more than 6 million Americans and remains a leading cause of mortality, with less than half of patients living beyond 5 years after diagnosis and less than a third living past 10 years. It is also linked to high rates of hospital readmissions, with about 25% of patients returning within a month of discharge.

References

1. Restore Medical receives breakthrough device designation from FDA for ContraBand system to treat HFrEF patients. News release. Restore Medical. July 18, 2024. Accessed July 18, 2024. https://www.prnewswire.com/news-releases/restore-medical-receives-breakthrough-device-designation-from-fda-for-contraband-system-to-treat-hfref-patients-302200547.html
2. Restore Medical. Accessed July 18, 2024. https://restoremedical.co/
3. Restore Medical announces successful first-in-human preliminary results of its CONTRABAND™ system for symptomatic systolic heart failure patients. News release. Restore Medical. March 7, 2023. Accessed July 18, 2024. https://www.prnewswire.com/news-releases/restore-medical-announces-successful-first-in-human-preliminary-results-of-its-contraband-system-for-symptomatic-systolic-heart-failure-patients-301764647.html
4. Restore Medical secures €2.5 million in EU funding for cardiac implants to treat heart failure. CTech. June 28, 2022. Accessed July 18, 2024. https://www.calcalistech.com/ctechnews/article/rjejifvqq