ARISTA™ AH

Arista™AH Absorbable Hemostatic
Powder with MPH Technology

The Latest Generation in Hemostasis from BARD®

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 is ineffective or impractical. 

SIMPLE:

Unlike other surgical hemostats, Arista™AH is ready on demand:

  • NO mixing
  • NO additional components
  • NO assembly
  • Room temperature shelf storage

NATURAL:

Arista™AH is a natural composition, synthesized from a purified plant polymer. As such it is non-toxic, non-irritating, non-hemolytic and non-mutagenic. It is non-immunogenic, and readily absorbed by tissue in 24 to 48 hours1Arista™AH reaches its maximum volume upon contact with blood or other fluids. No adverse events occurring in clinical studies were judged by the Data Safety Monitoring Board to be related to the use of Arista™AH. 

Unlike other surgical hemostats, Arista™AH:

  • Is 100% Plant-based & Thrombin-free, containing no human or animal components.
  • Is typically absorbable within 24-48 hours (minimum absorption time for other surgical hemostats is typically 3-8 weeks).1
  • Did not enhance infection of the wound site as indicated in preclinical study.2
  • Did not promote the formation of granuloma in preclinical study.2
  • Did not promote adhesions as indicated in a preclinical study.3
  • Is Cell Saver compatible with appropriate filters.4
     

EFFECTIVE.

The power of Arista™AH lies in its proprietary MPH™ (Microporous Polysaccharide Hemospheres) 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 flowable dry particles and the Arista™AH bellows applicator provide controlled delivery allowing complete coverage on either broad area surfaces or small, hard-to-reach places. Arista™AH has shown to be effective even in areas of profuse bleeding as shown in a rabbit femoral artery model study.

Please call 1-800-556-6275 to place an order today. 



 

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 is 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 clinical 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 neurological 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 Instructions for Use supplied with the product 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.davol.com.

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