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ActiGraft

The ActiGraft 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.

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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

• Provides the wound with an optimal, natural healing environment.
• Can be easily prepared at the patient’s point-of-care in 5 minutes.
• Requires no capital equipment
• Created from the patient's blood, assuring safe and effective management of the wound
• Approved 20 applications with superior coverage via NCD 270.3 & code G0465.
• Medicare Advantage patients are covered via NCD 270.3.
• For patients who have exhausted their CTP applications, ActiGraft provides an option for continued advance therapy.
• Patients with exposed bone & tendon are not excluded from the NCD coverage.
• ActiGraft can be applied on large and irregular wounds up to 56 cm2, offering excellent versatility
• Inclusive treatment solution for culturally and religiously sensitive patients—no bovine, porcine, placental, or any other third party products.

Indications

ActiGraft System 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 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 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, 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 was not verified to be in compliance with other wound care products. Assure the patient monthly ActiGraft blood draw is below 250ml per month. The ActiGraft 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 and can be used on up to 56 sq cm wound. Kit includes all components to complete procedure.
HCPCS Code
Product features
check_circle Blood draw required for process
cancel Contact manufacturer for details
check_circle 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
cancel Free Samples/Trials Available
check_circle Published Clinical Article Available
Recommended Use

Cavity Wounds
Chronic Wounds
Deep Wounds
Dehisced Wounds
Diabetic Foot
Granulating/Epithelializing Wounds
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Pressure Ulcers
Sloughy Wounds
Surgical Wounds
Venous Ulcers

Additional Recommended Dressings

Clinicians should use appropriate secondary dressings when apply ActiGraft. As an example, highly
exudating would should use an absorbent dressing and be changed at indicated.

Clinically Tested

Non-cytotoxic

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