Arista™ AH Absorbable Hemostat

•  Topical hemostats include agents that act as a mechanical barrier to bleeding and provide a physical matrix for clotting, biologically active agents that catalyze coagulation, and combination therapies. ²
• Hemostats can enhance clot formation and wound healing, and can be useful for controlling or preventing troublesome bleeding during surgical interventions where conventional methods of hemostasis are inadequate.²

• The acronym “RAPID” can be used to remember the application steps:
  
• R (Remove): Remove all access blood
• A (Apply): Apply AristaTM AH liberally to the bleeding site
• P (Pressure): Administer wound-appropriate pressure until hemostasis is achieved
• I (Irrigate): Irrigate and remove excess Arista™  AH from the site
• D (Done): Hemostasis Hemostasis achieved— quickly, safely and effectively

• With the FlexiTip™ spray applicator, applying Arista™ AH accurately and directly is fast and simple. The delivery system features a lightweight, plastic device with a long, flexible tube. The FlexiTip™  and FlexiTip™ XL extended reach applicator tips provide the precise and accurate delivery of Arista™ AH hemostatic powder from a simple, single-use device.¹
•  Arista Application: see instructions for use ¹  

• Directions for Use:

1.  Blot, wipe, or suction the bleeding tissue. It is important to remove excess blood so Arista™ AH may be applied immediately and directly to the site of active bleeding.
2. Position the applicator tip as close to the source of bleeding as possible. Immediately apply a liberal amount of Arista™ AH at the site of bleeding within the wound, to completely cover the wound. 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
3. Quickly apply wound-appropriate, direct pressure over the treated site. Use of a non-adhering substrate to apply pressure may prevent adhesion of  the  formed  clot to the surgical glove or other instrumentation. Amount and duration of pressure is wound dependent. For oozing, pressure may not be necessary. For more profusely bleeding wounds, pressure should be maintained longer.
4. If bleeding or oozing continues, remove excess Arista™ AH and reapply.
5.  If any material other than the clot-bound Arista™  AH  (i.e.  surgical dressing) adheres to the wound site, irrigate the material with saline and carefully remove it from the treated site.
6.  Immediately upon contact with blood or fluid, Arista™ AH will swell to approximately 5 times its original volume. Once hemostasis is achieved, excess Arista™ AH should be carefully removed by irrigation and aspiration. Avoid irrigation of direct suction of the formed blood clot.¹

• Administration: A liberal amount of Arista™ AH should be applied to the bleeding site (see DIRECTIONS FOR USE) followed by pressure until hemostasis  is  achieved.  After hemostasis is achieved, Arista™  AH  should  be  removed  by  irrigation  and/or  aspiration.¹

• A wide variety of topical hemostats are approved as adjunctive therapies in the maintenance of hemostasis during surgical procedures in which conventional methods are insufficient or not practical.²
•  Potential cost benefits in terms of preventing the further utilization of hospital resources to manage surgical bleeding. In addition to other patient blood management strategies, the intraoperative use of topical hemostats may reduce the need for transfusion of blood products (e.g., packed red blood cells, platelets, fresh frozen plasma) and reduce the duration of postoperative care (length of hospital stay) each of which is associated with substantial costs.²

PMA clinical trial (General, Orthopedic, Cardiac)

• Wisman, Craig (Bard Davol; 2015) Arresting hemostasis in surgical trauma applications

Cardiac & Vascular:

• Bruckner et al. (2014) Microporous polysaccharide hemosphere absorbable hemostat use in cardiothoracic surgical procedures
• Reynbakh et al. (2018) Use of MPH hemostatic powder for electrophysiology device implantation reduces postoperative rates of pocket hematoma and infection
• Bruckner and Loebe (2012a) Microporous polysaccharide hemosphere absorbable hemostat (AristaAH) use in re-operative cardiac surgical procedures.
• Bruckner and Loebe (2012b) The use of an absorbable microporous polysaccharide hemosphere haemostat (AristaAH) in ventricular assist device implant and cardiac transplantation procedures.
• Benlier et al. (2007) Microvascular anastomosis with minimal suture and arista: An experimental study

ENT:

• Antisdel et al. (2011) Microporous polysaccharide hemospheres do not increase synechiae after sinus surgery: Randomized controlled study
• Antisdel et al. (2009a) Effect of hemostatic Agent MPH on bleeding after endoscopic sinus surgery: A prospective randomized controlled study
• Antisdel et al. (2016) Product comparison model in otolaryngology: Equivalency analysis of absorbable hemostatic agents after endoscopic sinus surgery
• Phillips (2013) Safety and efficacy of Arista powder in 514 nasal septal and sinus surgery patients
• Sindwani (2009) Use of novel hemostatic powder MPH for endoscopic sinus surgery: Initial impressions
• Antisdel et al. (2008) Hemostatic agent Microporous Polysaccharide Hemospheres (MPH) does not affect healing or intact sinus mucosa

General:

• Egeli et al. (2012) Microporous polysaccharide hemospheres and seroma formation after mastectomy and axillary dissection in rats
• Humphreys et al. (2008a) Microporous polysaccharide hemospheres for management of laparoscopic trocar injury to the spleen
• Humphreys et al. (2008b) Renal injury and the application of polysaccharide hemospheres: A laparoscopic experimental model
•  Hoffmann et al. (2009) Choice of Hemostatic Agent Influences Adhesion Formation in a Rat Cecal Adhesion Mode
• Ereth et al. (2009) Microporous polysaccharide hemospheres do not enhance abdominal infection in a rat model compared with gelatin matrix

Urology

• Nunez-Nateras et al. (2013) Athermal nerve sparing robot-assisted radical prostatectomy: Initial experience with microporous polysaccharide hemospheres as a topical hemostatic agent
• Gilbert et al. (2016) Evaluation of Absorbable Hemostatic Powder for Prevention of Lymphoceles Following Robotic Prostatectomy With Lymphadenectomy
• Murat et al. (2006) Evaluation of microporous polysaccharide hemospheres for parenchymal hemostasis during laparoscopic partial nephrectomy in the porcine model