FDA Grants Breakthrough Designation to AbSolutions’ REBUILD Device

AbSolutions Med Inc. has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its REBUILD Bioabsorbable (REBUILD) abdominal wall closure device.

REBUILD potentially provides a new way to treat an often irreversibly debilitating condition: incisional hernia. Less than 7% of Breakthrough Devices are focused on general surgical products, 
 
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 cases.¹ 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,” AbSolutions Med CEO Dr. Daniel Jacobs said.
 
REBUILD is intended to support soft tissue approximation of the abdominal wall in conjunction with suture by distributing tension to maintain apposition of the rectus muscles during healing, which has been associated with reduction in post-operative ventral hernia formation. REBUILD is not cleared by the FDA and is not for sale.
 
AbSolutions Med, Inc. is a medical device company developing ways to rebuild the abdominal wall while maintaining normal anatomy and function.

Reference 
¹ Bosanquet DC, Ansell J, Abdelrahman T, Cornish J, … Torkington J (2015) Systematic Review and Meta-Regression of Factors Affecting Midline Incisional Hernia Rates: Analysis of 14,618 Patients. PLoS ONE 10(9): e0138745. DOI: 10.1371/journal.pone.0138745