Endoform™ Natural is an advanced extracellular matrix (ECM) for acute and chronic wounds. Incorporates into the wound and provides a porous bioscaffold for rapid cell infiltration to build new tissue.
• Enables broad-spectrum wound protease modulation • Helps indicate presence or absence of proteases and help restore protease balance and guide re-application rate • Provides an advanced extracellular matrix (ECM) with an intact scaffold and 150+ ECM proteins to help build new tissue • Compatible with NPWT, HBOT, compression therapy and offloading. • Accessible to health care professionals from day one
Endoform™ Natural is indicated for the management of acute and chronic wounds including partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites, grafts, post-Mohs surgery, post-laser surgery, podiatric and wound dehiscence), traumatic wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds.
Endoform™ Natural is derived from an ovine (sheep) source and should not be used on patients with known sensitivity to ovine (sheep) derived material.
Endoform™ Natural is not indicated for use on third degree burns.
Do not apply to wounds with uncontrolled clinical infection, acute inflammation, excessive exudate, or bleeding.
Endoform™ Natural is terminally sterilized via ethylene oxide. Do not use if the pouch is damaged.
Discard the device if mishandling has caused possible damage or contamination.
Single use product. Do not re-sterilize. Discard all unused portions. Device reuse may lead to wound infection.
Always handle Endoform™ Natural using aseptic technique.
Do not use past expiry date.
Users within the EU may access a Summary of Safety and Clinical Performance (SSCP) using Basic UDI-DI 0942190EDTBIOSCAFFOLD5Q through Eudamed (https://ec.europe.eu/tools/eudamed) or upon request.
Report any serious incident to Aroa Biosurgery via the local authorized representative (e.g. S4M Europe), as well the applicable Member State competent authority or other regulatory authority, in accordance with local requirements.
Endoform Natural should be stored at room temperature in a clean and dry area.
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
These recommendations are designed to serve only as a general guideline. They are not intended to supersede institutional protocols or professional clinical judgment concerning patient care.
Prepare the wound bed by cleansing, irrigation and if necessary, debride to remove debris, necrotic tissue or infected tissue. Select a sheet of the Endoform™ Natural which is slightly larger than the wound and apply aseptically. Endoform™ Natural can be applied as a whole sheet or trimmed so that it contacts the wound margins. Multiple sheets can be used to cover the entire wound bed. For ease of handling, apply device by placing the dry material in the wound and rehydrating with exudate or sterile saline. When hydrated Endoform™ Natural transforms into a soft conforming sheet. Ensure that the device conforms to the underlying wound bed. To protect Endoform™ Natural from adhering to the secondary dressing, consider applying a non-adherent dressing over the device to help protect the tissue while facilitating an optimal moist wound healing environment. Secure the device using an appropriate secondary dressing. The secondary dressing should be changed according to standard of care, taking into account the level of exudate. Endoform™ Natural can be used in conjunction with compression therapy, off-loading, and negative pressure wound therapy.
Duration of treatment and reapplication is determined by the physician and depends upon the wound type and conditions. The biodegradable Endoform™ Natural is absorbed and incorporated into the wound over time. Reapply when the device has been incorporated into the wound. It is recommended to assess the wound within 72 hours. Endoform™ Natural may last up to 7 days in the wound, depending on the wound environment. Carefully cleanse the wound surface in accordance with established procedures. Do not attempt to remove the off-white to golden gel that forms from residual Endoform™ Natural in the wound as it contains extracellular matrix components that assist in wound healing. If areas of the device are dry upon inspection, rehydrate with sterile saline and leave in place. It is not necessary to remove any residual Endoform™ Natural during dressing changes. However, if the product has been overlapped onto the peri-wound area, the remaining loose product that has not incorporated into the wound may be gently removed around the edges if desired. Change the secondary dressings as needed according to standard of care, taking into account the level of exudate, and when Endoform™ Natural is re-applied.
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