1. Based on Arista™ AH Instructions for Use: PK3798864.2015. 2. BD Data on file. Preclinical data may not correlate to clinical performance in humans. 3. Ereth MH, Dong Y, Schrader LM, Henderson NA, Agarwal S, Oliver WC, Nuttall GA. Microporous Polysaccharide Hemospheres do not enhance abdominal infection in a rat model compared with gelatin matrix. Surg Infect. 2009 Jun;10(3):273-6. 4. Hermans M, Brown L, Darmoc M. Adhesion prevention in an intraperitoneal wound model: Performance of two resorbable hemostats in a controlled study in rabbits. Journal of Biomedical Materials Research Part B: Applied Biomaterials. 2012;100B(6):1621-1626. doi:10.1002/jbm.b.32730 5. Erdogan H, Kelten B, Tuncdemir M, Erturkuner S, Uzun H, Karaoglan A. Hemostasis vs. epidural fibrosis?: A comparative study on an experimental rat model of laminectomy. Neurol Neurochir Pol. 2016;50(5):323-330. doi:10.1016/j.pjnns.2016.05.002 6. Hoffmann N, Siddiqui S, Agarwal S et al. Choice of Hemostatic Agent Influences Adhesion Formation in a Rat Cecal Adhesion Model. Journal of Surgical Research. 2009;155(1):77-81. doi:10.1016/j.jss.2008.08.008 7. Poehnert D, Neubert L, Klempnauer J, Borchert P, Jonigk D, Winny M. Comparison of adhesion prevention capabilities of the modified starch powder-based medical devices 4DryField® PH and Arista™ AH in the Optimized Peritoneal Adhesion Model. Int J Med Sci. 2019;16(10):1350-1355. doi:10.7150/ijms.33277 8. Singh P, Vasques D, Deleon F. Microporous Polysaccharide Hemospheres for Adhesion Prevention: A Randomized Controlled Trial. J Gynecol Surg. 2013;29(4):196-202. doi:10.1089/gyn.2013.0007 9. Arista™ AH PMA Clinical Study, P050038 Approval date September 26, 2006 10. Bruckner In vitro study comparing MPH human blood to human blood without MPH In vitro studies may not be predictive of clinical outcomes. 11. Neveleff, D.J. Optimizing hemostatic practices: matching the appropriate hemostat to the clinical situation. AORN J 96, S1-S17 (2012). 12. Doria, C. & Vaccino, S. Topical hemostasis: a valuable adjunct to control bleeding in the operating room, with a special focus on thrombin and fibrin sealants. Expert Opin Biol Ther 9, 243-247 (2009). 13. Marietta, M., Facchini, L., Pedrazzi, P., Busani, S. & Torelli, G. Pathophysiology of bleeding in surgery. Transplant Proc 38, 812-814 (2006). 14. Shander, A. Financial and clinical outcomes associated with surgical bleeding complications. Surgery 142, S20-25 (2007). 15. Boucher, B.A. & Traub, O. Achieving hemostasis in the surgical field. Pharmacotherapy 29, 2S-7S (2009). 16. Zimmerman, L.H. Causes and consequences of critical bleeding and mechanisms of blood coagulation. Pharmacotherapy 27, 45S-56S (2007). 17. Alstrom, U., Levin, L.A., Stahle, E., Svedjeholm, R. & Friberg, O. Cost analysis of re-exploration for bleeding after coronary artery bypass graft surgery. Br J Anaesth 108, 216-222 (2012). 18. Ye, X., Lafuma, A., Torreton, E. & Arnaud, A. Incidence and costs of bleeding-related complications in French hospitals following surgery for various diagnoses. BMC Health Serv Res 13, 186 (2013). 19. Based on 389894R04 – SURGICEL® Powder Instructions for Use (Code 3013SP) (Non-CE marked) 2017.
INDICATIONSArista™ AH is indicated in surgical procedures (except neurological and ophthalmic) as an adjunctive hemostatic device to assist when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures are ineffective or impractical.
CONTRAINDICATIONSDo not inject or place Arista™ AH into blood vessels as potential for embolization and death may exist.
WARNINGS
Arista™ AH is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.
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 removal of excess dry material.
Safety and effectiveness of Arista™ AH have not been clinically evaluated in children and pregnant 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.
v 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.
Safety and effectiveness in neurosurgical and ophthalmic procedures has not been established.
Arista™ AH should not be used for controlling post-partum bleeding or menorrhagia.
PRECAUTIONS
When Arista™ AH is used in conjunction with autologous blood salvage circuits, carefully follow instructions in the Administration section of the IFU 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 not recommended for the primary treatment of coagulation disorders.
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.
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.
In urological procedures, Arista™ AH should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation.
ADVERSE REACTIONSNone of the adverse events that occurred in a randomized prospective, concurrently controlled clinical trial were judged by the Data Safety Monitoring Board to be related to the use of Arista™ AH. The most common recorded adverse events were pain related to surgery, anemia, nausea, lab values out of normal range, arrhythmia, constipation, respiratory dysfunction and hypotension – all reported in greater than 10% of the Arista™ AH treated patients. The details of this clinical trial’s adverse events can be reviewed in the IFU supplied with the product and are also available at www.bd.com. Caution: Federal (USA) law restricts this device to sale by or on order of a licensed physician or properly licensed practitioner.
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