AbSolutions Med, Inc. Receives FDA Breakthrough Device Designation for its REBUILD™ Bioabsorbable Abdominal Wall Closure Device
MOUNTAIN VIEW, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- AbSolutions Med, Inc., a privately held medical device company, announced today that the Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its REBUILD Bioabsorbable (“REBUILD”) abdominal wall closure device.
- MOUNTAIN VIEW, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- AbSolutions Med, Inc., a privately held medical device company, announced today that the Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its REBUILD Bioabsorbable (“REBUILD”) abdominal wall closure device.
- REBUILD met the criteria set by the FDA for Breakthrough Devices, potentially providing a novel treatment of an often irreversibly debilitating condition: incisional hernia.
- Since the first documented laparotomy in 1809, general surgery has been challenged by its limitations in reliably managing a basic but fundamental aspect of abdominal surgery – closure of the abdominal wall.
- The impact of a failed abdominal closure can be devastating, with lifelong debilitation, morbidity, and re-operation occurring in a large percentage of patients.