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As Signum Surgical pursues broader commercialization to increase patient access to the FDA De Novo-authorized BioHealx® Anal Fistula Device, it is continuing to expand the clinical evidence supporting BioHealx Assisted Fistula Treatment (BAFT™). An ongoing multicenter post-market clinical study is
Clinical evidence is an important part of evaluating any new approach to anal fistula treatment. The BioHealx® Anal Fistula Device was evaluated in a prospective, multicenter first-in-human clinical study designed to assess its safety and effectiveness in treating cryptoglandular transsphincteric
Anal fistula repair remains a challenging problem. Existing surgical procedures include fistulotomy with or without sphincter repair, LIFT, endoanal flap and plugs. Reported failure rates for these traditional anal fistula procedures range from 30–70%.1,2 Many papers have been published over
What is an Anal Fistula? An anal fistula is a small tunnel that develops between the inside of the anus or rectum and the skin near the anus. It most often forms after an anal abscess (a pocket of infection)
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