SurgiWrap® FROST™ by MAST Biosurgery received FDA approval in January 2021. It is an innovative bioresorbable protective sheet designed to be used wherever temporary soft tissue support is required in various abdominal anatomy.
SurgiWrap FROST is fabricated from polylactic acid (PLA). The same lactic acid molecular building blocks are found naturally in the human body. It retains more than 60-80% of polymer integrity throughout the critical healing period of 8 weeks. The degradation of PLA occurs after the polymer is fragmented into smaller units which are eventually metabolized in the liver.
The WetGrip microsurface assists with intraoperative positioning and fixation. It is present on one side of the film, and does not adhere to the tissue. It attaches using the natural moisture present in the tissue to provide a benign and safe “magnet-like” attachment to the surgical site. The SurgiWrap FROST is available in three sizes (6.5 x 5 cm, 13 x 10 cm, and 20 x 13 cm) and has a thickness of 0.02 mm, which comes as a semi-transparent film. The film acts as a barrier and minimizes tissue adhesions to the device in case of direct contact with the viscera. It is used to reinforce soft tissues or bridging material where weakness exists like during hernia repair or other fascial defects.
The FDA has determined that SurgiWrap FROST is substantially equivalent to predicate devices. It shares indications and design principles with predicate device like SurgiWrap from MAST Biosurgery and reference device like Mesofol from Biomet, meeting the required safety and efficacy standards. Non-clinical testing has shown its mechanical strength to be substantially equivalent to its predicate device and is biocompatible.
The device is indicated for open and laparoscopic procedures. This includes, but is not limited to the following urological, gynecological and gastrointestinal procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, reconstruction of the pelvic floor, colon and rectal prolapse.
As for contraindications, SurgiWrap FROST should not be used in patients with active infection at the site of application.