The ActiGraft Pro® System is an autologous, point-of-care wound management solution, that uses the patient's own whole blood to reactivate healing in chronic, non-healing wounds.
• Covers the wound for long periods of time with minimal care between applications
• Provides the wound with an optimal, natural healing environment allowing the healing process to proceed unhindered
• Can be easily prepared at the patient’s point-of-care in 20 minutes or less and requires no capital equipment
• Created from the patient's blood, assuring safe and effective management of the wound
• Minimal handling of the wound provides a more comfortable treatment for patients
ActiGraft Pro® is intended to be used at point-of-care for the safe and rapid preparation of Whole Blood Clot (WBC) from a small sample of a patient's own peripheral blood. Under the supervision of a healthcare professional, the WBC produced by the ActiGraft Pro® is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, diabetic ulcers, and mechanically or surgically-debrided wounds.
ActiGraft Pro® is contraindicated in patients with wounds due to malignancy or wounds with active clinically diagnosed infection.
Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician. Throughout the processing and application of ActiGraft Pro®, use universal precautions as defined by the facility policy and procedure manual. All parts of the procedure shall be performed in such a manner as to minimize splashing, spattering and generation of potential droplets.
ActiGraft Pro® was not verified to be in compliance with other wound care products. Assure the patient monthly blood draw is below 250ml per month. The ActiGraft Pro® kit includes blood-contacting components that have been sterilized by ethylene oxide, which may cause serious allergic reactions in patients that are sensitized. Failure to follow instructions may lead to suboptimal outcomes or product failure. Outcomes may vary.
Store in the original container at a controlled room temperature of 5°C-30°C (41°F-86°F). Protect from freezing and avoid excessive heat.
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
ActiGraft Pro® is applied weekly.
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