Product Name: SUTUREGARD® Intraoperative Skin Relaxation (ISR) Retention Suture Device
Purpose: Stress-relax skin before wound closure to decrease wound tension or as an alternative to skin flaps, grafts and second intent healing.
Catalog/SKU #: SRD001
FDA Registration: 3015045268 (Class I)
Insurance: Kinsale Insurance Company, Policy #: 0100059727-2
Manufacturing Information: The SUTUREGARD® bridge is comprised of a stiff central elevated portion and two flexible and cushioned skin contact portions. The central portion protects the skin from clamping and un-clamping sutures. The flexible and cushioned skin contact arms provide a cushion to reduce pressure from the bridge on the skin. The SUTUREGARD® guide keeps the suture ends together to facilitate suture clamping and tensioning. All components pass biocompatibility FDA/GMP adhesive requirements.
Improved Patient Satisfaction: Surgeons can close wounds linearly that would otherwise require flaps or grafts, particularly on the scalp and nose. Patients report high satisfaction in avoiding flaps and grafts that require additional wounds and general anesthesia, and in retaining their natural hairline.
Reduced Cost of Care: Grafts and flaps are time-intensive, high-risk procedures that create additional wounds and in the hospital setting are often performed under general anesthesia.