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Arista™ Synthetic mesh Arista™ Absorbable Hemostat

SKU:

AM0005

GTIN:

00801741044076

Arista™ AH FlexiTip™ XL Applicator, 38 cm, 5 per Case

Name: Arista™ AH FlexiTip™ XL Applicator, 38 cm, 5 per Case
Brand: Arista™
SKU: AM0005

Simple. Safe. Effective.

Arista™ AH is indicated in surgical procedures (except neurologic 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.

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FEATURE AND BENEFIT CARDS NOT AVAILABLE

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1 Arista™ AH PMA P050038 Clinical Study.

2 See full Instructions for Use for detailed application instructions.

3 Arista™ AH Instructions for Use.

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.

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.

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GTIN

GTIN - Each

00801741044076

GTIN - Case

10801741044073

Packaging

Quantity

5/cs.

GTIN

GTIN - Each	00801741044076	1
GTIN - Case	10801741044073	10

Packaging

Quantity

5/cs.

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true

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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.
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.

Arista^TMAH is an absorbable powdered hemostatic agent intended for application to surgical wound sites to control bleeding. It is a fine, dry, sterilized white powder that is biocompatible, non-pyrogenic, and typically absorbed within 24-48 hours.

Arista™ AH is a 100% plant based absorbable surgical hemostatic powder derived from purified plant starch. The power of Arista™ AH lies in its Microporous Polysaccharide Hemospheres, a patented blood clotting technology. Consisting of microporous particles with a controlled pore size, the spheres are designed to act as a molecular sieve. The powerful osmotic action dehydrates and gels the blood on contact to accelerate the natural clotting process.

The best tools for blood clotting include hemostatic agents, thrombolytics, and anticoagulant medications.

In surgery, primary hemostasis techniques include removing all excess blood, applying the hemostat to the wound site, and adding pressure to the wound until hemostasis occurs.

Blood clot powder acts as a mechanical barrier to bleeding and provides a matrix that facilitates clotting alongside biological agents that catalyze coagulation in order to achieve hemostasis.

BD’s hemostatic powder is made of purified plant starch and microporous polysaccharide hemospheres.

A topical powder is a type of hemostat that is used for direct application to the wound site, helping to facilitate hemostasis by acting as a mechanical barrier.

Hemostatic powder is used to coagulate blood. BD offers Arista™ AH as a hemostatic blood clot powder.

While blood does coagulate naturally, according to a publication the best way to facilitate blood coagulation where traditional methods are no longer efficient is to use hemostatic agents.

In clinical trials, Arista™AH MPH hemostatic powder was found to significantly reduce the rate of overall post-procedural complications including pocket hematoma and infection.

A surgical hemostat is an agent that acts as a mechanical barrier to wound sites, facilitating blood coagulation and improving patient outcomes.

Surgical hemostasis is the act of stopping the free flow of blood from injury sites through blood coagulation. Typically, surgical hemostasis will involve hemostatic agents to facilitate blood coagulation.

Methods of surgical hemostasis include mechanical methods like gauze, sponges, or powder, thermal-based methods such as electrosurgery, and chemical methods such as pharmacological agents.

The acronym “RAPID” can be used to remember the application steps:

R (Remove): Remove all access blood
A (Apply): Apply Arista™ AH liberally to the bleeding site
P (Pressure): Administer wound-appropriate pressure until hemostasis is achieved
I (Irrigate): Irrigate and remove excess Arist™ 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. 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.

Apply a liberal amount of Arista™ AH to the bleeding site followed by pressure until hemostasis is achieved. After hemostasis is achieved, remove Arista™ AH by irrigation and/or aspiration.

Examples of surgeries that Arista™ AH can be used in include:

Cardiothoracic and cardiovascular
Vascular
Gynecological
Urology
Orthopedic surgery
General surgery
Plastic surgery
Ear
Nose
Throat (ENT) surgery

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.
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.

Simple to Use

Ready on demand
Simply pop the cap and apply the powder directly to the bleeding site
No mixing and no refrigeration
Five-year shelf life

Safe and Thrombin-Free

Synthesized from a purified plant starch
Thrombin-free, biocompatible and nonpyrogenic
Typically absorbed and cleared within 24–48 hours by amylases
Arista™ AH is the only currently available hemostat that is approved for cell salvage compatibility

Effective Hemostat

The clotting process begins on contact, regardless of patient’s coagulation status
Complete hemostasis can be achieved in minutes
Provides broad area coverage

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 mucosasa

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 matrixx

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

Arista™ AH IFU
Gabay, M. & Boucher, B.A. An essential primer for understanding the role of topical hemostats, surgical sealants, and adhesives for maintaining hemostasis. Pharmacotherapy 33, 935-955 (2013).
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
Data on file
ARISTA™ AH PMA Clinical Study P050038
BD Data on file. Preclinical data may not correlate to clinical performance in humans.
When Arista™ AH is used in conjunction with autologous blood salvage circuits, a 40 μ cardiotomy reservoir, cell washing, and 40 μ transfusion filter must be used.

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Alternatives Comparison

Alternatives Comparison
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- Product Name
  Arista™ AH FlexiTip™ XL Applicator, 38 cm, 5 per Case
- SKU Number
  am0005
- Quantity
  5/cs.

- Product Name
  Arista™ AH FlexiTip™ XL-R Applicator, rigid, 38 cm, 5 per Case
- SKU Number
  am0010
- Quantity
  5/cs.