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Avitene™ Arista™ Absorbable Hemostat

Avitene™ Microfibrillar Collagen Hemostat 1 g

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Overview

Simple. Safe. Effective.

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.

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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Features and Benefits
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Specification

GTIN - Each

00801741000386

1

GTIN - Case

10801741000383

6


Quantity

6/cs.


Dimensions

1.0 gram

GTIN

GTIN - Each 00801741000386 1
GTIN - Case 10801741000383 6

Packaging

Quantity 6/cs.

Product Basic Specification

Dimensions 1.0 gram
Electronic Instructions for Use (eIFUs)
Resources
Frequently Asked Questions

What is the Arista™ haemostatic agent?

  •  Topical haemostats include agents that act as a mechanical barrier to bleeding and provide a physical matrix for clotting, biologically active agents that catalyse coagulation, and combination therapies. 2
  • Haemostats can enhance clot formation and wound healing, and can be useful for controlling or preventing troublesome bleeding during surgical interventions where conventional methods of haemostasis are inadequate.2
  • Arista™ AH is an absorbable powdered haemostatic agent intended for application to surgical wound sites to control bleeding. It is a fine, dry, sterilised white powder that is biocompatible, non-pyrogenic, and typically absorbed within 24-48 hours." 

 

  • Arista™ AH is a 100% plant based absorbable surgical haemostatic powder derived from purified plant starch. The power of Arista™ AH lies in its Microporous Polysaccharide Haemospheres, 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." 

How Arista™ AH Works & Is Used

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

  • Cardiothoracic and cardiovascular
  • Vascular
  • Gynaecological
  • Urology
  • Orthopaedic
  • General
  • Plastic
  • Ear, Nose, Throat (ENT)

Advantages of Arista™ AH

  • A wide variety of topical haemostats are approved as adjunctive therapies in the maintenance of haemostasis during surgical procedures in which conventional methods are insufficient or not practical.2
  •  Potential cost benefits in terms of preventing the further utilisation of hospital resources to manage surgical bleeding. In addition to other patient blood management strategies, the intraoperative use of topical haemostats 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

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 life4

Thrombin-Free

  • Synthesised 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 haemostat that is approved for cell salvage compatibility1,6,7

Effective Haemostat

  • The clotting process begins on contact, regardless of patient’s coagulation status
  • Complete haemostasis can be achieved in minutes5
  • Provides broad area coverage

Arista™ AH Results and Case Studies

PMA clinical trial (General, Orthopedic, Cardiac)

Cardiac & Vascular:

ENT:

General:

Urology

References

 

  1. Arista™ AH IFU
  2. 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).
  3. 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
  4. Data on file
  5. ARISTA™ AH PMA Clinical Study P050038
  6. BD Data on file. Preclinical data may not correlate to clinical performance in humans.
  7. 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.

BD-53859

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  • Product Image
    • Product Name

      Avitene™ Microfibrillar Collagen Hemostat 1 g
    • SKU Number

      1010020
    • Dimensions

      1.0 gram
    • Quantity

      6/cs.
  • Product Image
    • Product Name

      Avitene™ Microfibrillar Collagen Hemostat 0.5 g
    • SKU Number

      1010010
    • Dimensions

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    • Quantity

      6/cs.
Related Products
References

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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