Arista™ AH used in a robotic-assisted total laparoscopic hysterectomy
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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
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 >>
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 >>
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
| Arista™ AH Absorbable Hemostatic Particles¹ | PerClot® Polysaccharide Hemostatic System | ||
| Available sizes | 3 sizes: 1 g, 3 g, 5 g¹ | 3 sizes: 1 g, 3 g, 5 g² | |
| Economic | Shelf life | 5 year shelf life. | 3 year shelf life |
| Tip delivery system | FlexiTip™ XL applicator, includes (1) applicator (length: 38 cm) FlexiTip™ XL-R applicator, rigid, 38 cm FlexiTip™ applicator, includes (2) applicators (length: 14 cm).³ The FlexiTip™ / FlexiTip™ XL Applicator can be easily trimmed in the event that tip clotting occurs. It is important to use sharp scissors to avoid crushing the tip.³ |
PerClot® applicators are available in the following lengths: 100 mm and 200 mm (available for 3 g only.)² Do not attempt to trim the applicator tip. In the event that the tip becomes occluded, use a new applicator.² |
|
| 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.¹ | Warning: Remove excess AMP® particles once hemostasis is achieved. This removal of excess particles is particularly important in and around the spinal cord, areas of bone confine, the optic nerve/chiasm, and foramina of bone because unsaturated particles may swell and compress the surrounding tissues.² |
| Absorption profile |
Arista™ AH absorption time: approximately 24–48 hours.¹* |
Absorption normally requires several days and is dependent on the amount of material applied and the site of use.² |
|
| Product | Device description |
Arista™ AH is a medical device intended for application to surgical wound sites as an absorbable hemostat. This technology incorporates hydrophilic, flowable, microporous particles synthesized by cross-linking purified plant starch through a proprietary process; Arista™ AH is a 100% plant-based polysaccharide.¹ |
PerClot® Polysaccharide Hemostatic System (PerClot® PHS) is a medical device composed of absorbable modified polymer (AMP®) particles and delivery applicators.² |
| Clinical study adverse 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.¹‚4 | A total of seven adverse events have been reported for PerClot® PHS. Five adverse events were reported during clinical use. Three were potential re-bleeding resulting from the unidentified bleeding source during myomectomy, emergency epistaxis and septoplasty. One adverse event was reported for aspiration of dry particles into the airway during tonsillectomy. One adverse event was regarding broken applicator.² |
|
| Treatment of deep wounds |
Deep wounds may require equally deep application of Arista™ AH. To minimize occlusion of the tip, pressure should be applied to deliver Arista™ AH as the applicator enters the wound.¹ |
Precaution: Visualization of the bleeding site is critical during the application of PerClot® PHS. The bleeding site must be exposed to ensure the hemostatic particles contact with the bleeding site prior to achieving hemostasis, or else rebleeding may occur. Especially for its application in myomectomy, it is hard for PerClot® PHS to reach the actual bleeding site, so the hemostasis is not achieved.2 |
|
| Laparoscopic and endoscopic use |
Available with a FlexiTip™ XL-R applicator for endoscopic/laparoscopic procedures.¹ |
For specific surgical procedures, the system is configured in both PerClot® Standard and PerClot® Laparoscopic. (Available for 3 g only)² |
|
| Procedure | Cell saver compatible |
Arista™ AH is compatible with a 20–40µ size range for autologous blood salvage systems.¹ |
Precaution: When an extracorporeal cardiopulmonary bypass circuit or autologous blood salvage circuit is used in conjunction with PerClot® PHS, care must be exercised to prevent possible particle entry into the bypass circuit. Entry is prevented by using a 40µ cardiotomy reservoir, cell washing, and a 40µ transfusion filter (such as a LipiGuard®).² |
| ENT use | No warnings, contraindications or adverse events directly related to ENT use.¹ |
Warning: When PerClot® PHS is used in the nasal cavity and laryngopharyngeal, PerClot® PHS should be used with caution to avoid the dry particles being drawn into the trachea or bronchi, which may form a gel that blocks the trachea and bronchi.² |
|
| Urological procedures |
In urological procedures, Arista™ AH should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation.¹ |
PerClot® PHS should not be left in bladder, ureteral lumen or renal pelvis to eliminate the potential foci for calculus formation.² |
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.
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