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https://na-sj04.marketodesigner.com/m?explictHostname=app-sj04.marketo.com#LPTE5875 Arista AH – General Advancing the world of health ALL POWDERS ARE NOT CREATED EQUAL THE DIFFERENCE IS PUTTING PRECISION TO WORK MANUFACTURED FROM A PURIFIED PLANT STARCH, ARISTA™ AH ABSORBABLE HEMOSTAT HAS BEEN SHOWN TO PROVIDE MANY BENEFITS.1 PRECLINICAL STUDIES DEMONSTRATE THAT ARISTA™ AH: DOES NOT POTENTIATE INFECTION1,2,3 DOES NOT PROMOTE ADHESIONS2, 4-8 DOES NOT SHOW EVIDENCE OF FOREIGN BODY REACTION2,9 DOES NOT INTERFERE WITH NATURAL HEALING2,9 Play Video Play Mute Current Time 0:00 / Duration Time 1:29 Loaded: 0% 0:00 Progress: 0% 0:00 Progress: 0% Stream TypeLIVE Remaining Time -1:29 Share Playback Rate 1 * Chapters Chapters * descriptions off, selected Descriptions * subtitles off, selected Subtitles * captions settings, opens captions settings dialog * captions off, selected Captions * en (Main), selected Audio Track Fullscreen This is a modal window. Caption Settings Dialog Beginning of dialog window. Escape will cancel and close the window. TextColorWhiteBlackRedGreenBlueYellowMagentaCyanTransparencyOpaqueSemi-TransparentBackgroundColorBlackWhiteRedGreenBlueYellowMagentaCyanTransparencyOpaqueSemi-TransparentTransparentWindowColorBlackWhiteRedGreenBlueYellowMagentaCyanTransparencyTransparentSemi-TransparentOpaque Font Size50%75%100%125%150%175%200%300%400% Text Edge StyleNoneRaisedDepressedUniformDropshadow Font FamilyProportional Sans-SerifMonospace Sans-SerifProportional SerifMonospace SerifCasualScriptSmall Caps DefaultsDone Close Modal Dialog This is a modal window. This modal can be closed by pressing the Escape key or activating the close button. Close Modal Dialog This is a modal window. This modal can be closed by pressing the Escape key or activating the close button. Arista™ AH used in a robotic-assisted total laparoscopic hysterectomy Discovery. Diagnostics. Delivery. CAN BE ACCESSED ON OUR CUSTOMER LEARNING PORTAL. THE E-LEARNING COURSES OFFER DETAILED AND SOLUTION FOCUSED TRAINING TO HELP BETTER UNDERSTAND HOW TO SOLVE FOR COMMON SCENARIOS. Play Video Play Mute Current Time 0:00 / Duration Time 1:29 Loaded: 0% 0:00 Progress: 0% 0:00 Progress: 0% Stream TypeLIVE Remaining Time -1:29 Share Playback Rate 1 * Chapters Chapters * descriptions off, selected Descriptions * subtitles off, selected Subtitles * captions settings, opens captions settings dialog * captions off, selected Captions * en (Main), selected Audio Track Fullscreen This is a modal window. Caption Settings Dialog Beginning of dialog window. Escape will cancel and close the window. TextColorWhiteBlackRedGreenBlueYellowMagentaCyanTransparencyOpaqueSemi-TransparentBackgroundColorBlackWhiteRedGreenBlueYellowMagentaCyanTransparencyOpaqueSemi-TransparentTransparentWindowColorBlackWhiteRedGreenBlueYellowMagentaCyanTransparencyTransparentSemi-TransparentOpaque Font Size50%75%100%125%150%175%200%300%400% Text Edge StyleNoneRaisedDepressedUniformDropshadow Font FamilyProportional Sans-SerifMonospace Sans-SerifProportional SerifMonospace SerifCasualScriptSmall Caps DefaultsDone Close Modal Dialog This is a modal window. This modal can be closed by pressing the Escape key or activating the close button. Close Modal Dialog This is a modal window. This modal can be closed by pressing the Escape key or activating the close button. Experts from around the globe describe the intersection between patient and healthcare worker safety, focusing on techniques to improve both occupational and public health. Webinar Objectives: * Describe the current global impact of bloodborne disease * Describe occupational exposure incidents for needlesticks and sharps injuries * Define safety as a function of focus for both patient and health worker, to reduce overall bloodborne disease * Provide guidance on the importance of prevention programs including use of safer medical devices, immunization/vaccination programs, and safe clinical practices * Illustrate an effective pathway for reporting exposure incidents and injuries * Define processes for post-exposure medical treatment and prophylaxis * Share global experiences from key stakeholders responsible for sharps safety and public health programs around the world Save Your Seat ARISTA™ AH CAN PROVIDE A SIMPLE, SAFE AND EFFECTIVE SOLUTION FOR INTRAOPERATIVE BLEEDING IN GENERAL SURGERY PROCEDURES.1 VIDEOS EXPLORE OUR LIBRARY OF TECHNIQUE VIDEOS DEMONSTRATING THE EFFECTIVENESS OF ARISTA™ AH. WATCH NOW CASE STUDY TOTAL LAPAROSCOPIC HYSTERECTOMY SURGERY USING ARISTA™ AH ABSORBABLE HEMOSTATIC PARTICLES TO CONTROL INTRAOPERATIVE BLEEDING. VIEW CASE STUDY EDUCATION ACCESS THE BD BIOSURGERY EDUCATIONAL PROGRAMS, DESIGNED TO PROVIDE YOU WITH IN-DEPTH EDUCATION ON THE TECHNIQUES AND UTILIZATION OF OUR HEMOSTAT AND SEALANT PORTFOLIO OF PRODUCTS. VIEW UPCOMING EVENTS ARISTA™ AH ARISTA™ 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.8 SURGICEL® POWDER WARNING: SURGICEL® POWDER IS DRY AND THERE MAY BE DIFFICULTIES IN PRECISE DELIVERY UNDER CERTAIN CIRCUMSTANCES. UNINTENTIONAL DEVICE PLACEMENT MAY RESULT IN POWDER SCATTERING AND DEVICE MIGRATION THAT MAY INCREASE THE RISK OF ADHESION FORMATION.9 HEMOBLAST™ BELLOWS THERE IS A RISK OF HUMAN PARVOVIRUS B19 TRANSMISSION. HUMAN PARVOVIRUS B19 MOST SERIOUSLY AFFECTS PREGNANT WOMEN OR IMMUNE-COMPROMISED INDIVIDUALS. IT IS NOT KNOWN WHETHER HEMOBLAST™ BELLOWS CAN CAUSE FETAL HARM WHEN ADMINISTERED TO PREGNANT WOMEN OR CAN AFFECT REPRODUCTION CAPACITY.10 Play Video Play Mute Current Time 0:00 / Duration Time 0:00 Loaded: 0% Progress: 0% Stream TypeLIVE Remaining Time -0:00 Playback Rate 1 * Chapters Chapters * descriptions off, selected Descriptions * subtitles off, selected Subtitles * captions settings, opens captions settings dialog * captions off, selected Captions Audio Track Fullscreen This is a modal window. THE VIDEO CLOUD VIDEO IS NOT PLAYABLE. Error Code: VIDEO_CLOUD_ERR_NOT_PLAYABLE Session ID: 2023-09-21:fd5a844215d95358f4524e5 Player ID: vjs_video_1894 OK Close Modal Dialog Caption Settings Dialog Beginning of dialog window. Escape will cancel and close the window. TextColorWhiteBlackRedGreenBlueYellowMagentaCyanTransparencyOpaqueSemi-TransparentBackgroundColorBlackWhiteRedGreenBlueYellowMagentaCyanTransparencyOpaqueSemi-TransparentTransparentWindowColorBlackWhiteRedGreenBlueYellowMagentaCyanTransparencyTransparentSemi-TransparentOpaque Font Size50%75%100%125%150%175%200%300%400% Text Edge StyleNoneRaisedDepressedUniformDropshadow Font FamilyProportional Sans-SerifMonospace Sans-SerifProportional SerifMonospace SerifCasualScriptSmall Caps DefaultsDone Close Modal Dialog This is a modal window. This modal can be closed by pressing the Escape key or activating the close button. Click here to view our video library showcasing Arista™ AH used in gynecologic surgery. What you use matters CLICK TO LEARN MORE > Uncontrolled bleeding can reduce visualization of the surgical field, increase morbidity and mortality rates from 0.5% to 20%, and often prolong, interrupt, or complicate surgical procedures.11-16 Blood transfusion can cost between $700-800 and increase hospital costs.17-18 Length of stay was extended on average by 3.1 - 6.4 days in patients that received transfusions compared to those who did not receive a transfusion.17-18 Let's have a conversation Critical healing from the start Predictable strength for the long run RAPID TISSUE INCORPORATION 1 ORGANIZED AND FUNCTIONAL COLLAGEN AT THE REPAIR SITE1 4X THE STRENGTH OF THE NATIVE ABDOMINAL WALL AT 24 WEEKS IN PRECLINICAL TESTING1 LONG-TERM STRENGTH WITH NO PERMANENT MATERIAL LEFT BEHIND1,2,3 OVER 2X THE STRENGTH OF OTHER BIORESORBABLE MESH3 PELLENTESQUE HABITANT MORBI * Tristique senectus et netus et malesuada * Tristique senectus et netus et malesuada * Tristique senectus et netus et malesuada * Tristique senectus et netus et malesuada PELLENTESQUE HABITANT MORBI * Tristique senectus et netus et malesuada * Tristique senectus et netus et malesuada * Tristique senectus et netus et malesuada * Tristique senectus et netus et malesuada PREDICTABLE STRENGTH FOR THE LONG RUN * Long-term strength with no permanent material left behind2,3 * Organized and functional collagen at the repair site3 ARISTA™ AH VS PERCLOT® PHS COMPARATIVE STUDY OF RESORPTION AND IMMUNE RESPONSE. Read The Study Store Prepare Track Dispense Administer Document STORE TAB 360° rotation knob is effectively sized, contoured and located to enable easy instrument rotation. 360° rotation knob is effectively sized 360° rotation knob is effectively sized 360° rotation knob is effectively sized More product details PREPARE TAB More product details TRACK TAB Play Video Play Mute Current Time 0:00 / Duration Time 0:00 Loaded: 0% 0:00 Progress: 0% 0:00 Progress: 0% Stream TypeLIVE Remaining Time -0:00 Share Playback Rate 1 * Chapters Chapters * descriptions off, selected Descriptions * subtitles off, selected Subtitles * captions settings, opens captions settings dialog * captions off, selected Captions Audio Track Fullscreen This is a modal window. THE VIDEO CLOUD VIDEO IS NOT PLAYABLE. Error Code: VIDEO_CLOUD_ERR_NOT_PLAYABLE Session ID: 2023-09-21:1a585328e6cf08e63662bb95 Player ID: vjs_video_2265 OK Close Modal Dialog Caption Settings Dialog Beginning of dialog window. Escape will cancel and close the window. TextColorWhiteBlackRedGreenBlueYellowMagentaCyanTransparencyOpaqueSemi-TransparentBackgroundColorBlackWhiteRedGreenBlueYellowMagentaCyanTransparencyOpaqueSemi-TransparentTransparentWindowColorBlackWhiteRedGreenBlueYellowMagentaCyanTransparencyTransparentSemi-TransparentOpaque Font Size50%75%100%125%150%175%200%300%400% Text Edge StyleNoneRaisedDepressedUniformDropshadow Font FamilyProportional Sans-SerifMonospace Sans-SerifProportional SerifMonospace SerifCasualScriptSmall Caps DefaultsDone Close Modal Dialog This is a modal window. This modal can be closed by pressing the Escape key or activating the close button. Close Modal Dialog This is a modal window. This modal can be closed by pressing the Escape key or activating the close button. More product details DISPENSE TAB More product details ADMINISTER TAB More product details DOCUMENT TAB Play Video Play Mute Current Time 0:00 / Duration Time 0:00 Loaded: 0% 0:00 Progress: 0% 0:00 Progress: 0% Stream TypeLIVE Remaining Time -0:00 Share Playback Rate 1 * Chapters Chapters * descriptions off, selected Descriptions * subtitles off, selected Subtitles * captions settings, opens captions settings dialog * captions off, selected Captions Audio Track Fullscreen This is a modal window. THE VIDEO CLOUD VIDEO IS NOT PLAYABLE. Error Code: VIDEO_CLOUD_ERR_NOT_PLAYABLE Session ID: 2023-09-21:1e80ed9c6672e89c5503605b Player ID: vjs_video_2625 OK Close Modal Dialog Caption Settings Dialog Beginning of dialog window. Escape will cancel and close the window. TextColorWhiteBlackRedGreenBlueYellowMagentaCyanTransparencyOpaqueSemi-TransparentBackgroundColorBlackWhiteRedGreenBlueYellowMagentaCyanTransparencyOpaqueSemi-TransparentTransparentWindowColorBlackWhiteRedGreenBlueYellowMagentaCyanTransparencyTransparentSemi-TransparentOpaque Font Size50%75%100%125%150%175%200%300%400% Text Edge StyleNoneRaisedDepressedUniformDropshadow Font FamilyProportional Sans-SerifMonospace Sans-SerifProportional SerifMonospace SerifCasualScriptSmall Caps DefaultsDone Close Modal Dialog This is a modal window. This modal can be closed by pressing the Escape key or activating the close button. Close Modal Dialog This is a modal window. This modal can be closed by pressing the Escape key or activating the close button. More product details DOCUMENT TAB Play Video Play Mute Current Time 0:00 / Duration Time 1:58 Loaded: 0% 0:00 Progress: 0% 0:00 Progress: 0% Stream TypeLIVE Remaining Time -1:58 Share Playback Rate 1 * Chapters Chapters * descriptions off, selected Descriptions * subtitles off, selected Subtitles * captions settings, opens captions settings dialog * captions off, selected Captions * en (Main), selected Audio Track Fullscreen This is a modal window. Caption Settings Dialog Beginning of dialog window. Escape will cancel and close the window. 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More product details Hospitals and healthcare facilities Pharmacies Physician offices Hospitals and healthcare facilities BD is a market leader in hospital products that can reduce the incidence of sharps injuries and exposure to bloodborne pathogens. Patient safety has been a focus of BD innovation for years, not only in the United States but also around the world. Working closely with organizations like the International Safety Center (EPINet) is an important part of our efforts to keep patients and workers safe. Safety syringes and needles >> Hazardous drug safety >> Infection prevention >> Pharmacies BD pharmacy products are designed to enhance medication preparation and delivery while helping facilitate compliance. By working closely with pharmaceutical and biotech companies worldwide, we are continuing to help reduce medication errors and improve patient safety. We also provide pharmacy disposal solutions to help ensure the safe disposal of various types of sharps. Syringes and needles >> Safe hazardous drug handling practices assessment >> Browse all hazardous drug safety products >> Physician offices Occupational exposure to bloodborne pathogens from needlesticks and other sharps injuries is a serious problem that is not limited to hospitals. Any worker handling sharp devices or equipment—such as scalpels, sutures, hypodermic needles, blood collection devices or phlebotomy devices—is at risk for sharps-related injuries. By working with BD products, physician offices can take the first course of action toward providing safe sharps disposal and addressing needlestick injury from injections. Diabetes care >> Interventional specialties >> Browse all interventional specialties products >> Hospitals and healthcare facilities Pharmacies Physician offices General resources Hospitals and healthcare facilities BD is a market leader in hospital products that can reduce the incidence of sharps injuries and exposure to bloodborne pathogens. Patient safety has been a focus of BD innovation for years, not only in the United States but also around the world. Working closely with organizations like the International Safety Center (EPINet) is an important part of our efforts to keep patients and workers safe. Safety syringes and needles >> Hazardous drug safety >> Infection prevention >> Pharmacies BD pharmacy products are designed to enhance medication preparation and delivery while helping facilitate compliance. By working closely with pharmaceutical and biotech companies worldwide, we are continuing to help reduce medication errors and improve patient safety. We also provide pharmacy disposal solutions to help ensure the safe disposal of various types of sharps. Syringes and needles >> Safe hazardous drug handling practices assessment >> Browse all hazardous drug safety products >> EXPANDED PORTFOLIO SPANNING THE VASCULAR ACCESS CONTINUUM Products proven to help reduce the risk of complications For device selection and placement: Peripheral IV catheters >> Advanced Peripheral IV catheters >> Midlines >> PICCs >> Central venous catheters >> Guidance technologies >> For prep, care and maintenance: Skin prep >> Antimicrobial Dressings >> Stabilization >> Needle-free connectors >> Disinfecting cleaner >> Pre-filled flush syringes >> Dressing change kits >> General resources BD is an industry leader in safety, offering a comprehensive line of safety-engineered medical devices. We are committed to working with our customers to find real solutions that address sharps injuries and exposure to hazardous drugs. As a leader, we also offer various resources on safety for the healthcare industry. Safety-related press releases Safety-related resources Government, organizational and private sector safety-related resources The proprietary Arista™ AH powder achieves broad area coverage5 on rough surfaces and in hard-to-reach areas,6 for rapid control of bleeding in minutes.1 E-learning courses PELLENTESQUE HABITANT MORBI TRISTIQUE SENECTUS ET NETUS ET MALESUADA FAMES AC TURPIS EGESTAS VESTIBULUM TORTOR QUAM. User group webcasts PELLENTESQUE HABITANT MORBI TRISTIQUE SENECTUS ET NETUS ET MALESUADA FAMES AC TURPIS EGESTAS VESTIBULUM TORTOR QUAM. Let's have a conversation E-learning courses User group webcasts Let's have a conversation E-learning courses User group webcasts Let's have a conversation CONSIDERATIONS WHEN SELECTING A POWDERED HEMOSTAT1,19 Arista™ AH Absorbable Hemostatic Particles SURGICEL® Powder Right sizing: Cost effective and reduces waste 3 sizes: 1 g, 3 g, 5 g 1 size: 3 g Economic Shelf life and storage 5 year shelf life. Arista™ AH should be stored to avoid temperature extremes (less than -40°C [-40°F] and greater than 60°C [140°F]). 18 month shelf life. Store at controlled room temperature 15°C-30°C (59°F-86°F). Tip delivery system FlexiTip™ XL applicator, includes (1) applicator (length: 38 cm) FlexiTip™ XL-R applicator, rigid, 38 cm FlexiTip™ XL applicator, includes (2) applicators (length: 14 cm) SURGICEL® Endoscopic Applicator Patient’s coagulation status Arista™ AH begins the clotting process on contact, regardless of the patient’s coagulation status. No data available. Patient Swelling Warning–Arista™ AH swells to its maximum volume immediately upon contact with blood or other fluids. 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. Contraindication: When SURGICEL® Powder is used to help achieve hemostasis in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, or the optic nerve and chiasm, it must always be removed after hemostasis is achieved since it will swell and could exert unwanted pressure. Adhesion formation No warnings or contraindications. Warning: SURGICEL® Powder is dry and there may be difficulties in precise delivery under certain circumstances. Unintentional device placement may result in powder scattering and device migration that may increase the risk of adhesion formation. Cell saver compatibility Arista™ AH is a cell saver compatible hemostat. SURGICEL® Powder should not be used in conjunction with autologous blood salvage circuits, because its fragments may pass through the transfusion filters of blood-scavenging systems. Laparoscopic and endoscopic use Available with a FlexiTip™ XL-R applicator for endoscopic / laparoscopic procedures. The SURGICEL™ Endoscopic Applicator is supplied with a flexible inner tip inserted into a rigid cannula. It is intended to be used only with the SURGICEL® Powder absorbable hemostat. The SURGICEL™ Endoscopic Applicator is for single use only and must be discarded after use. Procedure Urological procedures Precaution: In urological procedures, Arista™ AH should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation. Precaution: In uroglogical procedures, minimal amounts of SURGICEL® Powder should be used and care must be exercised to prevent plugging of the urethra, ureter, or a catheter by dislodged portions of the product. ENT use No warnings, contraindications or adverse events directly related to ENT use. Adverse reaction: Burning has been reported with other SURGICEL® products were applied after nasal polyp removal. Headache, burning, stinging, and sneezing in epistaxis and other rhinological procedures, and stinging when SURGICEL® product was applied on surface wounds (varicose ulcerations, dermabrasions, and donor sites) have also been reported. Absorption profile Arista™ AH absorption time: approximately 24–48 hours. ASURGICEL® Powder fully absorbs within 7 to 14 days. When used properly in minimal amounts, SURGICEL® Powder is absorbed from the sites of implantation with practically no tissue reaction. Absorption depends on several factors, including the amount used, degree of saturation with blood, and the tissue bed. Product Method of action Arista™ AH particles are hydrophilic molecular sieves that enhance natural hemostasis by concentrating blood solids such as platelets, red blood cells, and blood proteins on the particle surfaces to form a gelled matrix. The concentrated gel matrix provides a barrier to further blood loss and is formed regardless of the patient’s coagulation status. The concentration of clotting factors and platelets in the gel serves to enhance normal clotting reactions and creates stable hemostatic plugs. The absorption process begins immediately and is dependent on several factors, including the amount applied and site of use. The mechanism of action whereby SURGICEL® Powder (oxidized regenerated cellulose) accelerates clotting is not completely understood, but it appears to be a physical effect rather than any alteration of the normal physiologic clotting mechanism. After SURGICEL® Powder has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a hemostatic adjunct in the control of local hemorrhage. Foreign body reactions Per a randomized clinical study – there were no adverse events during clinical studies that were judged related to the device by the Data Safety Monitoring Board Foreign body reactions have been reported with other products from the SURGICEL® Family of Absorbable Hemostats. Access case studies and procedure videos Please enable Javascript to view this form. REFERENCES 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. INDICATIONS Arista™ 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. CONTRAINDICATIONS Do 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 REACTIONS None 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. BD-71971 BD is committed to keeping your personal data protected and secure. More information on how we protect your personal data can be found in our privacy statement and our cookie policy. 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