Product Name: HEMIGARDT® Adhesive Retention Suture Device
Manufacturer: SUTUREGARD Medical, Inc.
Purpose: For suturing fragile skin wounds under tension.
Catalog/SKU #: HRD001
FDA Registration: 3015045268 (Class I)
Insurance: Kinsale Insurance Company, Policy #: 0100059727-2
Manufacturing Information: The bottom layer of the HEMIGARD device is responsible for adhesion to the skin. The rigid hemi-bridge layer with holes is designed to withstand high tension retention sutures. The top layer is made of transparent, rigid film to allow the top surface to be wiped clean and to displace the wound tension away from the wound edges.
All components pass biocompatibility FDA/GMP adhesive requirements.
Improved Patient Satisfaction: Surgeons can close wounds simply that would otherwise tear under the force of sutures. This allows for linear closure in many wounds that would otherwise require more complex care (grafts, flaps or chronic wound care for second intent). Patients report high satisfaction in avoiding these procedures and with the appearance of the final scar..
Reduced Cost of Care: Grafts and flaps are time-intensive, high-risk procedures that create additional wounds. Second intent healing requires ongoing wound care.