Dive Brief:
- Absolutions Med has received breakthrough designation for an abdominal wall closure device that is intended to reduce the risk of hernia.
- The Food and Drug Administration designation, which Absolutions disclosed Wednesday, covers a device designed to distribute suture tension over a large area of tissue.
- Absolutions began testing the device, Rebuild Bioabsorbable, in cancer patients undergoing abdominal surgeries in 2022, and the company began a study in a broader population in March 2023.
Dive Insight:
Open abdominal surgery, a procedure known as laparotomy, is used to explore the causes of symptoms such as unexplained pain, to remove organs and tumors, and otherwise to diagnose and treat disease. Surgeons perform more than 4 million laparotomies a year in the U.S.
In some patients, the intestine, organ or other tissue protrudes through the site of the surgical incision. A literature review found the complication, called an incisional hernia, affects around 13% of patients who undergo midline incisions, although in one study the prevalence was more than 35%. The hernias are associated with infection, pain and serious complications such as bowel obstruction.
Absolutions is developing Rebuild Bioabsorbable to ensure closure of the abdominal wall and prevent incisional hernias. The company has identified the propensity for sutures to cut through tissue as a cause of the failure of abdominal wall closure. Absolutions’ device is designed to spread the force of the sutures over a wider area to prevent the tearing of tissue.
Other companies have shown mesh implants reduce the risk of incisional hernia, but there are doubts about whether the benefits outweigh potential complications in the long-term. Absolutions has made its device from a bioabsorbable material to reduce the risk of complications.
The company is closing in on human data on the device, with a trial that, after a one-month follow-up, will assess abdominal wall integrity three, six, 12 and 24 months after surgery. The study is scheduled to reach primary completion in September.
The breakthrough designation positions Absolutions to benefit from greater interaction with the FDA as it works to bring the device to market.
