Aurix™ is a biodynamic hematogel that harnesses a patient's innate healing mechanisms to jumpstart the natural healing process for a broad range of chronic non-healing wounds.
• Clinically proven with demonstrated efficacy
• FDA approval for all chronic wounds
• Rapid point of care treatment, 1 minute spin
• Treatment for chronic wounds at any stage
• Reimbursed by CMS
Aurix™ is intended to be used at the point-of-care for the safe and rapid preparation of platelet-rich-plasma (PRP) gel from a small sample of a patient's own blood. Under supervision of a health care professional, the PRP gel produced by the Aurix™ system is suitable for exuding wounds, such as leg ulcers, pressure injuries, and diabetic ulcers and for the management of mechanically or surgically-debrided wounds.
Contraindicated for use in: patients known to be sensitive to components and/or materials of bovine origin; patients on chemotherapeutic agents; patients with the following abnormal laboratory test levels: hemoglobin <10.5 g/dL, platelet count <100,000, serum albumin level <2.5 g/dL; wounds due to malignancy; wounds with active clinically diagnosed infection.
Federal Law (USA) restricts this device to sale by or on the order of a physician.
Precautions: Throughout the processing procedure and the application of Aurix™, use universal precautions as defined by the facility policy and procedure manual.
Warnings: Reagent kit and dressing contain dry natural rubber. Aurix™ is produced with the use of bovine
Allergic reactions may be encountered in persons known to be sensitive to bovine materials.
Because of thrombin's action in the clotting mechanism, Aurix™ must not be injected or otherwise allowed to enter large blood vessels. Extensive intravascular clotting may occur.
Storage, wound dressing kit: At room temperature, 15°C-25°C (59°F-77°F)
Storage, reagent kit: Upon arrival or within 14 days of shipment, store at 2°C-8°C (36°F-46°F)
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Aurix™ is applied onto the wound area by first filling any undermined areas, tunnels, or sinus tracts using the blunt needle. Apply the selected primary dressing (non absorbent, non-cytotoxic) over the contact layer interface. Apply a secondary dressing (absorbent) to further secure and protect the primary dressing. These dressings may be left in place until the next Aurix™ treatment. If the secondary dressing becomes soiled, it should be changed. However, the primary dressing should be undisturbed for 24-48 hours post application. If the primary dressing is changed between Aurix™ applications, the wound bed may be carefully cleaned using extreme care to avoid disturbing new granulation tissue. No cytotoxic cleansers, anti-infectives, or pressurized cleansing should be used. Appropriate moist wound dressings may then be applied until the next Aurix™ application.
The Aurix system may be used for chronic or surgically-debrided wounds up to twice a week for 8 weeks.
The treating health care practitioner may elect to continue the treatment up to 12 weeks.
The health care professional can choose the type of dressing to cover the Aurix™ using the following guidelines.
It is recommended that a high MVTR transparent dressing such as Tegaderm™ (3M) be used to cover the Aurix™. Do not use dressings that will absorb Aurix™ and prevent it from contacting cells in the wound bed. Aurix™ contains active proteins that must contact cells in the wound bed so it is important to use products that will not degrade or inhibit proteins.
The Aurix System™ includes: Aurix™ Centrifuge II leased from Nuo Therapeutics, Aurix System™ Wound Dressing Kit, Aurix System™ Reagent Kit, A single application license to use the patented PRP gel process
The Aurix System™ Wound Dressing Kit contains single-use, disposable components for performing a patient phlebotomy, centrifuging blood to derive PRP and activating and applying the Aurix™. The Aurix System™ Reagent Kit contains components, such as thrombin, that activate platelets and ascorbic acid which assist with the gel consistency. Our small, quiet portable centrifuge has a 60 second spin cycle to produce biodynamic hematogel efficiently at the point-of-care. The disposable kit components eliminate shelf life and transportation issues. The small-volume blood draw, ease of operation and portability make the Aurix System™ ideal for all types of clinical care settings.
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