OR-YEHUDA, Israel, July 18,
2024 /PRNewswire/ -- Restore Medical, a pioneering
medical device company in the field of interventional cardiology,
is proud to announce that it has been granted Breakthrough Device
Designation by the U.S. Food and Drug Administration (FDA) for its
ContraBand™ device. This 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 program is intended to
expedite the development and review of medical devices that offer
significant advantages over existing treatments for serious or
life-threatening conditions. 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.
ContraBand™ is the world's first 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. FDA's decision to grant Breakthrough Device
Designation was based on compelling results from an ongoing
feasibility study demonstrating promising outcomes in safety and
efficacy. These results include significant left ventricular volume
reduction, improved hemodynamic function, and enhanced
physical capacity in patients treated with the ContraBand™
device.
About Restore Medical:
Restore Medical Ltd. is a privately held company dedicated to
revolutionizing the treatment of heart failure. The company was
founded by Stephen Bellomo, who
serves as CTO, Dr. Elchanan
Bruckheimer, who serves as Medical Director, and
Aaron Feldman. The company is led by
CEO Gilad Marom. Restore Medical is
funded by Peregrine Ventures, the European Innovation Council
(EIC), and an undisclosed strategic investor, reflecting strong
support and confidence in its mission and innovative technology.
For more information, please visit: https://restoremedical.co
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SOURCE Restore Medical Ltd.