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ActiGraft Pro® System

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.

RedDress

RedDress is committed to improving the health and lives of patients around the world by revolutionizing the way chronic wounds are treated. Their innovative products are advanced, biologic wound care solutions that reproduce the natural wound healing processes of the body.
Toll free:(800) 674-9615 Fax:(800) 561-8127 Website: www.reddressmedical.com
Benefits

• 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

Indications

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.

Contraindications

ActiGraft Pro® is contraindicated in patients with wounds due to malignancy or wounds with active clinically diagnosed infection.

Warnings and Precautions

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.

Adverse Effects/Reactions

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.

Storage Requirements

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.

How Supplied/Sizing
Clot size: 28sq cm. Kit includes all components to complete procedure.
Product features
check_circle Blood draw required for process
cancel Contact manufacturer for details
cancel FDA cleared/approved for bone/tendon
cancel FDA cleared/approved for burns
check_circle Kit components included
check_circle No centrifuge required
check_circle Portable preparation device
check_circle Same day procurement application
cancel Skin punch/shave needed to procure tissue
Other features
check_circle Educational Material Available
check_circle Free Samples/Trials Available
check_circle Published Clinical Article Available
Recommended Use

Acute Wounds
Chronic Wounds
Deep Wounds
Diabetic Foot
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Pressure Ulcers
Skin Tears
Sloughy Wounds
Surgical Wounds
Traumatic Wounds
Venous Ulcers

Removal & Change Frequency

ActiGraft Pro® is applied weekly.

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