INDICATIONS FOR USE
The nSTRIDE APS System including ACD-A is designed to be used for the safe and rapid preparation of autologous protein solution (APS) from a small sample of blood at the patient’s point of care. Health care professionals use the nStride APS System to mitigate symptoms of knee osteoarthritis such as pain and inflammation.
CONTRAINDICATIONS
- nSTRIDE APS System including ACD-A is not for use in patients with systemic inflammatory conditions.
- Do not inject APS in the knees of patients having knee joint infections or skin diseases or infections in the area of the injection site.
- nSTRIDE APS Kit is not intended for use in patients with leukemia, metastatic malignant cells, or who are receiving chemotherapeutic treatment.
POSSIBLE ADVERSE EFFECTS FROM BLOOD DRAW AND INTRA-ARTICULAR INJECTION
- Damage to blood vessels, hematoma and/or infection.
- Temporary or permanent nerve damage that may result in pain or numbness.
- Transient pain, swelling, burning and/or effusion of the injected joint may occur after intra-articular injection of APS.
- Early or late post-injection infection.
DISCLOSURE OF RESIDUAL RISKS:
While complications and side effects vary depending on the type of orthopedic surgery and while mitigations are implemented to reduce these risks as far as possible, some residual risks, associated with this system, that can arise during and following surgery include:
- Adverse local tissue reaction (ALTR)
- Severe systemic reaction to allergen or toxin
- Systemic organ failure or dysfunction
- Severe systemic infection
- Critical pain or ache