FDA Approves Adhesion Prevention Solution for Surgery

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The FDA recently approved Adept from Innovate PLC (formerly ML Labs) as an adhesion prevention agent following gynecologic laparoscopic surgery.  I know this product well as I was involved in the original US Pilot study in 2001.  There are few products approved for this use at open surgery but none before have been approved for laparoscopic surgery.  Many have tried and failed!  Adaept is essentially a starch based solution (4% Icodextrin) that is placed in the abdominal and pelvic cavity during surgery.  It works via osmotic gradients to pull water into the pelvic cavity.  This is the old “hydroflotation” strategy whereby fluid causes cut structures to float away from each other and not adhere during healing.  This concept was originally developed with plain ringer’s solution then replaced with Hyskon.  Resuts were very minimal when these were fianlly tested (despite years of use).

 Adept was originally developed for use in peritoneal dialysis. The US trials for approval for use in surgery demonstrated a reduction in the number of adhesions when it was used versus controls.  Adept 45% with a decrease in scar sites versus 35% in the control arm.  Interestingly, for the two other main outcomes of efficacy Adept failed to meet significance.  The FDA panel voted to approve it nonetheless in view of its excellent safet record and use outside the USA since 1999 with minimal adverse effects.  Actual efficacy is however less than I would have liked to see in this study. 

Other devices available currently in the market include Interceed from J&J (not approved for laparoscopic use) and Seprafilm (not approved for laparoscopic use– potentially better but a NIGHTMARE to use at laparoscopy since it sticks to everything then disolves.

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