Instructions for Use (Summary)*
- 1.0 The Aurix® System
- 2.0 Preparation
- 3.0 The Aurix® System Procedure
- 4.0 Composition, Storage and Handling of Aurix® System
1.0 The Aurix® System
1.1 The Aurix System Includes:
- Aurix System Centrifuge
- Aurix System Wound Dressing Kit including single-use components for patient phlebotomy, platelet rich plasma (PRP) processing, and patient application.
- Aurix System Reagent Kit including components for processing and activating the PRP.
1.2 Indications For Use
The Aurix System is intended to be used at 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 the supervision of a healthcare professional, the PRP gel produced by the Aurix System is suitable for exuding wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers; and for the management of mechanically or surgically debrided wounds.
The Aurix System may be used for chronic or surgically-debrided wounds. The treating health care practitioner may elect to continue the treatment up to twelve (12) weeks. The Aurix System should be used in conjunction with standard of care procedures as prescribed by a healthcare professional for comprehensive wound management such as:
- Removal of necrotic or infected tissue
- Compression therapy for venous stasis ulcers
- Establishment of adequate blood circulation
- Maintenance of a moist wound environment
- 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
The Centers for Medicare & Medicaid Services (CMS) will reimburse for autologous platelet-rich plasma (PRP) for the treatment of chronic non-healing diabetic wounds, using an FDA-cleared device, under section 1862(a)(1)(A) of the Social Security Act (the Act) for a duration of 20 weeks.
Aurix is contraindicated in the following patients or wounds:
- Patients known to be sensitive to components and/or materials of bovine origin
- Patients on chemotherapeutic agents
- Wounds due to malignancy
- Wounds with active clinically diagnosed infection
1.5 Precautions And Warnings
Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician.
Precautions: Throughout the processing procedure and application of Aurix, use universal precautions as defined by the facility policy and procedure manual. All parts of the procedure shall be performed in such a manner to minimize splashing, spraying, spattering, and generation of potential droplets.
Warnings: Aurix is produced with the use of bovine thrombin.
- 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 and even death may result.
1.6 Symbols And Certifications