Arista™ AH PMA P050038 Clinical Study.
See full Instructions for Use for detailed application instructions.
Arista™ AH Instructions for Use.
Disclaimers
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Please consult product labels and instructions for use for indications, contradictions, hazards, warnings, and precautions.
Indications
Arista™ AH is indicated in surgical procedures (except ophthalmic) as an adjunctive hemostatic device to assist when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
Contraindications
Do not inject or place Arista™ AH into blood vessels as the potential for embolization and death may exist.
Warnings
Safety and effectiveness of Arista™ AH has not been clinically evaluated in children, pregnant, and/or breast-feeding women. Because there have been reports of decreased amylase activity in newborns up to 10 months, absorption rates of Arista™ AH in this population may be longer than 48 hours.
Once hemostasis is achieved, excess Arista™ AH should be removed from the site of application by irrigation and aspiration particularly when used in and around foramina of bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm. Arista™ AH swells to its maximum volume immediately upon contact with blood or other fluids. Dry, white Arista™ AH should be removed. The possibility of the product interfering with normal function and/or causing compression necrosis of surrounding tissues due to swelling is reduced by the removal of excess dry material.
This device has been designed for single use only. Reuse, resterilization, reprocessing and/or repackaging may compromise the essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient. Reuse, reprocessing, resterilization, or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient or end user.
Arista™ AH is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.
Safety and effectiveness in ophthalmic procedures has not been established.
Arista™ AH should not be used for controlling post-partum bleeding or menorrhagia.
Arista™ AH should be used with caution in the presence of infection or in contaminated areas of the body. If signs of infection or abscess develop where Arista™ AH has been applied, re-operation may be necessary in order to allow drainage.
Discard device after use. This product may be a potential biohazard. Handle and dispose in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.
Precautions
Only physicians qualified in the appropriate surgical techniques should use this device.
The safety and effectiveness for use in neurological procedures has not been established through randomized clinical studies.
When Arista™ AH is used in conjunction with autologous blood salvage circuits, carefully follow instructions in the Administration section regarding proper filtration and cell washing.
Arista™ AH is intended to be used in a dry state. Contact with saline or antibiotic solutions prior to achieving hemostasis will result in loss of hemostatic potential.
Arista™ AH is supplied as a sterile product and cannot be resterilized. Unused, open containers of Arista™ AH should be discarded.
Do not apply more than 50g of Arista™ AH in diabetic patients as it has been calculated that amounts in excess of 50g could affect the glucose load.
Arista™ AH is not recommended for the primary treatment of coagulation disorders.
In urological procedures, Arista™ AH should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation.
No testing has been performed on the use of Arista™ AH on bone surfaces to which prosthetic materials are to be attached with adhesives and is therefore not recommended.
Adverse Reactions
In a randomized prospective, concurrently controlled clinical trial, a total of 288 randomized patients received Arista™ AH or the Control (Gelatin Sponge with or without Thrombin). The most common recorded adverse events were pain related to surgery, anemia, nausea, and lab values out of normal range. The following is a complete list of adverse events reported in greater than 5% of the Arista™ AH treated patients. The corresponding adverse events for the Control group are listed for comparison. None of the adverse events that occurred were judged by the Data Safety Monitoring Board to be related to the use of Arista™ AH. Please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions, and instructions for use.
BD-51218 (08/22)
