Northwell’s Staten Island University Hospital Performs First U.S. Procedure With New BioHealx Device for Complex Anal Fistulas
STATEN ISLAND, N.Y.–(BUSINESS WIRE)–Northwell’s Staten Island University Hospital (SIUH) is the first medical center in the United States to perform surgery using the newly FDA-cleared BioHealx ®Anal Fistula Device – offering new hope to patients suffering from complex and often debilitating anal fistulas. The procedures were performed by colorectal surgeons Poppy Addison, MD, and Giovanni Bonomo, MD, director of colorectal surgery.
The BioHealx device, developed by Irish-based Signum Surgical, represents a significant advancement in the treatment of complex anal fistulas, notoriously difficult to treat with current surgical options. The minimally invasive, absorbable implant is designed to close fistula tract as it traverses the anal sphincter complex, without involving any significant disruption of the anorectal anatomy. Early European data demonstrated an 84% success rate, far exceeding traditional approaches that often have success rates closer to 60% and are associated with the need for multiple procedures to finally achieve healing.
“Historically, these surgeries have been long, complex, traumatic to the anorectum and carried the risk of recurrence and incontinence,” said Dr. Bonomo. “The BioHealx device is intuitive, efficient, and minimizes surgical trauma. If we can replicate the European outcomes, this could set a new standard of care in fistula treatment.”
Approximately, 90,000 complex anal fistula procedures are performed yearly. These fistulas predominantly affect men between ages 18 and 50, and disrupts their quality of life due to anal pain, foul-smelling drainage, and recurrent infection. Fistulas can recur even after what appears to be healing at the skin level due to persistence of the transsphincteric fistula tract, and many patients undergo multiple interventions before finding relief.
“Rectal fistulas are under-researched and have lacked a reliable, standardized solution,” said Dr. Addison. “This device has the potential to optimize care, shorten recovery, and reduce recurrence, all while preserving continence, which is a critical concern for our patients.”
Before surgery, a seton drain is placed to help mature the fistula tract and to provide for clear identification of the internal fistula opening. During the BioHealx procedure, the seton is removed, the tract is brushed clean, and a small flap is created to expose the internal sphincter at the location of internal opening. The corkscrew-shaped BioHealx implant is then inserted to compress the tissue around the fistula tract as it traverses the width of the sphincter complex to deliver primary healing by direct tissue apposition. The flap is closed over the internal opening and internal anal sphincter, while the outer tract is partially opened for optimal drainage – all without damaging the sphincter muscle nor disrupting the anal canal. The implant itself is made from bioabsorbable polylactic glycolic acid and naturally dissolves in the body within six to twelve months, leaving no permanent material behind.
Read the full article here.