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Restrata®
Restrata® is a fully synthetic hybrid-scale fiber matrix manufactured with synthetic bioresorbable polymers and possesses a fibrous structure with high porosity. The product architecture, which is similar to native extracellular matrix, allows for cell ingress and retention, as well as neovascularization of the newly forming tissue without the need for added growth factors.
Acera Surgical, Inc
Acera Surgical, Inc
Acera Surgical, Inc. is a bioscience company developing engineered synthetic solutions for a variety of regenerative medical and surgical applications.
Non-meshed: (1/2)"x1", 1"x1", 1"x2", 1(1/2)"x2", 1"x3", 2"x2", 3"x3", 4"x5", 5"x7". Meshed: 1(1/2)"x2", 2"x2", 3"x3", 4"x5", 5"x7".
• Fully synthetic
• Excellent biocompatibility
• Versatility
• Consistency
• Ease-of-Use
• As the wound healing process progresses, Restrata® completely degrades via hydrolysis, leaving native tissue in its place
• Shelf stable and carries a 2-year shelf life
Restrata® is intended for the use in the management of wounds, including partial- and full-thickness wounds, pressure injuries, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (eg, donor site/grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, dehisced wounds), trauma wounds (e.g. abrasions, lacerations, partial-thickness burns, skin tears, or draining wounds.
This device is not indicated for use in third-degree burns.
This device should not be used in patients with known sensitivity to resorbable suture materials.
• Do not use the product if there is evidence of container damage
• Do not use the product after the expiration date listed on the packaging
• Do not resterilize
• Device is sterile if the package is unopened and undamaged
• Discard device if mishandling has caused possible damage or contamination
• Debridement or excision must be done thoroughly to remove any remaining non-viable or necrotic tissue
that may cause infection
• Restrata® should not be applied until excessive exudate, bleeding, acute swelling, and infection is controlled
Complications are possible such as chronic inflammation, infection, or allergic reaction. If any of these occur, the device should be removed.
Store at room temperature. Avoid excessive heat or humidity. Refrigeration of Restrata® is not necessary.
Polyglactin 910 and polydioxanone
Select appropriate size product. Cut to fit and fenestrate or mesh if desired. Hydrate with saline if desired. Affix with sutures, staples, or wound closure strips. Cover with non-adherent dressing to protect Restrata®. Can be used with any type of secondary dressings or NPWT. Reapply weekly or as needed (product typically resorbs in 2 weeks).
