Less than 7% of Breakthrough Devices are in the field of general surgery, making REBUILD a standout product in a sector of medicine struggling to make profound advances
REBUILD supports the abdominal wall closure by distributing suture tension over a large area of tissue. (Credit: Piron Guillaume on Unsplash)
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 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. Less than 7% of Breakthrough Devices are in the field of general surgery, making REBUILD a standout product in a sector of medicine struggling to make profound advances.
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. Clinical failure of the closure from sutures tearing through tissue leads to incisional hernia in up to 35.6% of cases1. The impact of a failed abdominal closure can be devastating, with lifelong debilitation, morbidity, and re-operation occurring in a large percentage of patients.
REBUILD supports the abdominal wall closure by distributing suture tension over a large area of tissue to maintain apposition of the midline fascial structures during the critical period of healing after surgery, and is then absorbed so as to minimize the risk of long-term foreign body complications. REBUILD has been tested in both animal and human studies with promising outcomes.
“The field of hernia repair and hernia prevention has been dominated exclusively by various mesh products. REBUILD takes a different approach, focusing on the root cause of the problem by supporting intrinsic tissue healing, designed to eliminate long-term foreign bodies, and potentially improving patient quality of life by breaking the vicious cycle of repairs, complications and re-operations,” said Dr. Daniel Jacobs, CEO of AbSolutions Med.
Source: Company Press Release