ActiGraft Pro: Revolutionary Wound Care Management System

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RedDress Medical, the American-Israeli medical company behind the advanced ActiGraft wound care systems, announced that their proprietary medical technology is now available in 40 countries across five continents, providing a viable alternative to more people around the world suffering from chronic and festering wounds that refuse to heal.

The 40 countries that RedDress has confirmed active commercial agreements with include Brazil, Canada, Hong Kong, India, Mexico, Russia, Turkey, United Arab Emirates, South Africa, Ireland, Italy, and more.

ActiGraft wound management systems produce in vitro blood clots from a patient’s own blood. Once applied, the autologous blood clot serves as a protective covering and initiates wound-healing processes — which naturally occur in the human body — giving diabetics, senior citizens, and others dealing with chronic wounds or healing deficiencies an additional tool to help them heal properly.

According to a study in the American Journal of Surgery, it is estimated that 1 to 2 percent of the world’s population will experience a chronic wound during their lifetime in developed countries. For developing countries, this is estimated to be higher. With more than 159 million people likely to experience a chronic wound in their lifetime, medical experts at RedDress say now is the time to address these issues with innovation and perseverance.

“With so many people across the globe living with healing-deficient medical conditions, such as diabetes, cardiovascular disease and obesity, it’s important that we not only develop a better treatment option for chronic wounds, but make it available to as many people as possible,” said Robert Mueller, general manager of RedDress. “We have found ActiGraft to be a very effective option for clinicians and healthcare systems globally. The combination of ActiGraft’s efficacy and cost profile finally provides clinicians an advanced option where limited options existed before due to cost constraints. We are very pleased to be changing how the world delivers healing.”

According to RedDress, the company has already obtained FDA clearance, as well as its CE marking from the European Union (EU), for the ActiGraft wound care system. The EU CE marking indicates that a medical device complies with applicable regulations, allowing RedDress’ cutting-edge technology to be sold to countries within the EU and expediting the process to become available to additional EU countries.

Looking forward, RedDress is working to get ActiGraft integrated into the United Kingdom’s national health system and France’s universal health coverage system.

According to innovators from RedDress, the company plans to launch an upgraded wound management system to the ActiGraft suite of wound healing solutions in the fall of 2022. The soon-to-be-released wound care system features an advanced patented coagulant formula that produces a thick, easy-to-apply, whole blood clot, making wound care treatment more easily manageable for clinicians.

How ActiGraft Pro® System Works

Derived from your patient’s own blood, the ActiGraft Pro® whole blood clot is embedded with essential wound healing elements such as red blood cells, macrophages, platelets, proteins, clotting factors, minerals, electrolytes and dissolved gasses, bound within a natural fibrin scaffold. Once applied to the wound site, ActiGraft Pro reactivates the body’s natural healing cascade and serves as a protective covering that supports the body’s healing process,
accelerating your patient’s road to recovery.

ActiGraft Pro Procedure

In just a few simple steps, ActiGraft Pro is prepared at your patient’s point-of-care in 20 minutes or less.

Indications for Use

ActiGraft® System (RD2 System) is intended to be used at point-of-care for the safe and rapid preparation of Whole Blood Clot (WBC) gel from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the WBC gel produced by 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.

Important Safety Information

ActiGraft was not verified to be compatible with other wound care products. Assure the patient monthly blood draw is below 250ml per month. Throughout the processing and application of ActiGraft System, 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 of blood. The ActiGraft System 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.

Use of the System:
The ActiGraft should be used in conjunction with standard of care procedures for comprehensive wound management such as:
• Removal of necrotic or infected tissue
• Off-loading
• Compression therapy for venous stasis ulcers
• Establishment of adequate blood circulation
• Management of wound infection
• Wound cleansing
• Nutritional support, blood glucose control for subjects with diabetic ulcers
• Bowel/bladder care for subjects with pressure ulcers at risk for contamination
• Management of underlying disease

Contraindications:
The ActiGraft is contraindicated in patients with the following types of wounds:
• Wounds due to malignancy
• Wounds with active clinically diagnosed infection

Precautions:
• Some blood-contacting components of the ActiGraft have been sterilized by Ethylene Oxide, which can cause serious allergic reactions in some sensitized individuals.
• 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.
• Calcium gluconate should only be used with ActiGraft system.
• Calcium gluconate (Preservative Free): Use only if solution is clear and seal intact.
• Calcium Gluconate Note: Supersaturated solutions are prone to precipitation. The precipitate, if present, may be dissolved by warming the vial to 60C to 80C, with occasional agitation, until the solution becomes clear. Shake vigorously. Allow to cool to room temperature before dispensing. Use Calcium Gluconate only if clear immediately prior to use.
• If a patient complaint on increase in pain in the days following ActiGraft application, even if the clot is complete and intact, consider to remove the clot to expose the wound and explore for possible infection in the wound or in the near area.

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