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Arista AH – General
Advancing the world of health

ALL POWDERS ARE NOT CREATED EQUAL

THE DIFFERENCE IS

PUTTING PRECISION
TO WORK

MANUFACTURED FROM A PURIFIED PLANT STARCH,
ARISTA™ AH ABSORBABLE HEMOSTAT HAS BEEN SHOWN TO PROVIDE MANY BENEFITS.1

PRECLINICAL STUDIES DEMONSTRATE THAT ARISTA™ AH:

DOES NOT POTENTIATE INFECTION1,2,3

DOES NOT PROMOTE ADHESIONS2, 4-8

DOES NOT SHOW EVIDENCE OF FOREIGN BODY REACTION2,9

DOES NOT INTERFERE WITH NATURAL HEALING2,9

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Arista™ AH used in a robotic-assisted total laparoscopic hysterectomy

Discovery. Diagnostics. Delivery.

CAN BE ACCESSED ON OUR CUSTOMER LEARNING PORTAL. THE E-LEARNING COURSES OFFER
DETAILED AND SOLUTION FOCUSED TRAINING TO HELP BETTER UNDERSTAND HOW TO SOLVE
FOR COMMON SCENARIOS.

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Experts from around the globe describe the intersection between patient and
healthcare worker safety, focusing on techniques to improve both occupational
and public health.

Webinar Objectives:

* Describe the current global impact of bloodborne disease
* Describe occupational exposure incidents for needlesticks and sharps injuries
* Define safety as a function of focus for both patient and health worker, to
reduce overall bloodborne disease
* Provide guidance on the importance of prevention programs including use of
safer medical devices, immunization/vaccination programs, and safe clinical
practices
* Illustrate an effective pathway for reporting exposure incidents and injuries
* Define processes for post-exposure medical treatment and prophylaxis
* Share global experiences from key stakeholders responsible for sharps safety
and public health programs around the world

Save Your Seat

ARISTA™ AH CAN PROVIDE A SIMPLE, SAFE AND EFFECTIVE SOLUTION FOR INTRAOPERATIVE
BLEEDING IN GENERAL SURGERY PROCEDURES.1

VIDEOS

EXPLORE OUR LIBRARY OF TECHNIQUE VIDEOS DEMONSTRATING THE EFFECTIVENESS OF
ARISTA™ AH.

WATCH NOW

CASE STUDY

TOTAL LAPAROSCOPIC HYSTERECTOMY SURGERY USING ARISTA™ AH ABSORBABLE HEMOSTATIC
PARTICLES TO CONTROL INTRAOPERATIVE BLEEDING.

VIEW CASE STUDY

EDUCATION

ACCESS THE BD BIOSURGERY EDUCATIONAL PROGRAMS, DESIGNED TO PROVIDE YOU WITH
IN-DEPTH EDUCATION ON THE TECHNIQUES AND UTILIZATION OF OUR HEMOSTAT AND SEALANT
PORTFOLIO OF PRODUCTS.

VIEW UPCOMING EVENTS

ARISTA™ AH

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.8

SURGICEL® POWDER

WARNING: SURGICEL® POWDER IS DRY AND THERE MAY BE DIFFICULTIES IN PRECISE
DELIVERY UNDER CERTAIN CIRCUMSTANCES. UNINTENTIONAL DEVICE PLACEMENT MAY RESULT
IN POWDER SCATTERING AND DEVICE MIGRATION THAT MAY INCREASE THE RISK OF ADHESION
FORMATION.9

HEMOBLAST™ BELLOWS

THERE IS A RISK OF HUMAN PARVOVIRUS B19 TRANSMISSION. HUMAN PARVOVIRUS B19 MOST
SERIOUSLY AFFECTS PREGNANT WOMEN OR IMMUNE-COMPROMISED INDIVIDUALS. IT IS NOT
KNOWN WHETHER HEMOBLAST™ BELLOWS CAN CAUSE FETAL HARM WHEN ADMINISTERED TO
PREGNANT WOMEN OR CAN AFFECT REPRODUCTION CAPACITY.10

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Click here to view our video library showcasing Arista™ AH used in gynecologic
surgery.

What you use matters

CLICK TO LEARN MORE >

Uncontrolled bleeding can reduce visualization of the surgical field, increase
morbidity and mortality rates from 0.5% to 20%, and often prolong, interrupt, or
complicate surgical procedures.11-16

Blood transfusion can cost between $700-800 and increase hospital costs.17-18

Length of stay was extended on average by 3.1 - 6.4 days in patients that
received transfusions compared to those who did not receive a transfusion.17-18

Let's have a conversation

Critical healing from the start Predictable strength for the long run

RAPID TISSUE INCORPORATION 1

ORGANIZED AND FUNCTIONAL COLLAGEN AT THE REPAIR SITE1

4X THE STRENGTH OF THE NATIVE ABDOMINAL WALL AT 24 WEEKS IN PRECLINICAL TESTING1

LONG-TERM STRENGTH WITH NO PERMANENT MATERIAL LEFT BEHIND1,2,3

OVER 2X THE STRENGTH OF OTHER BIORESORBABLE MESH3

PELLENTESQUE HABITANT MORBI

* Tristique senectus et netus et malesuada
* Tristique senectus et netus et malesuada
* Tristique senectus et netus et malesuada
* Tristique senectus et netus et malesuada

PELLENTESQUE HABITANT MORBI

* Tristique senectus et netus et malesuada
* Tristique senectus et netus et malesuada
* Tristique senectus et netus et malesuada
* Tristique senectus et netus et malesuada

PREDICTABLE STRENGTH FOR THE LONG RUN

* Long-term strength with no permanent material left behind2,3
* Organized and functional collagen at the repair site3

ARISTA™ AH VS PERCLOT® PHS COMPARATIVE STUDY OF RESORPTION AND IMMUNE RESPONSE.

Read The Study

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Hospitals and
healthcare facilities Pharmacies Physician
offices

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 >>

Pharmacies

BD pharmacy products are designed to enhance medication preparation and delivery
while helping facilitate compliance. By working closely with pharmaceutical and
biotech companies worldwide, we are continuing to help reduce medication errors
and improve patient safety. We also provide pharmacy disposal solutions to help
ensure the safe disposal of various types of sharps.

Syringes and needles >>
Safe hazardous drug handling practices assessment >>
Browse all hazardous drug safety products >>

Physician offices

Occupational exposure to bloodborne pathogens from needlesticks and other sharps
injuries is a serious problem that is not limited to hospitals. Any worker
handling sharp devices or equipment—such as scalpels, sutures, hypodermic
needles, blood collection devices or phlebotomy devices—is at risk for
sharps-related injuries. By working with BD products, physician offices can take
the first course of action toward providing safe sharps disposal and addressing
needlestick injury from injections.

Diabetes care >>
Interventional specialties >>
Browse all interventional specialties products >>

Hospitals and
healthcare facilities Pharmacies Physician
offices General
resources

Hospitals and healthcare facilities

Safety syringes and needles >>
Hazardous drug safety >>
Infection prevention >>

Pharmacies

Syringes and needles >>
Safe hazardous drug handling practices assessment >>
Browse all hazardous drug safety products >>

EXPANDED PORTFOLIO SPANNING THE VASCULAR ACCESS CONTINUUM

Products proven to help reduce the risk of complications

For device selection and placement: Peripheral IV catheters >> Advanced
Peripheral IV catheters >> Midlines >> PICCs >> Central venous catheters >>
Guidance technologies >>

For prep, care and maintenance: Skin prep >> Antimicrobial Dressings >>
Stabilization >> Needle-free connectors >> Disinfecting cleaner >> Pre-filled
flush syringes >> Dressing change kits >>

General resources

BD is an industry leader in safety, offering a comprehensive line of
safety-engineered medical devices. We are committed to working with our
customers to find real solutions that address sharps injuries and exposure to
hazardous drugs. As a leader, we also offer various resources on safety for the
healthcare industry.

Safety-related press releases
Safety-related resources
Government, organizational and private sector safety-related resources

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

E-learning courses

PELLENTESQUE HABITANT MORBI TRISTIQUE SENECTUS ET NETUS ET MALESUADA FAMES AC
TURPIS EGESTAS VESTIBULUM TORTOR QUAM.

User group webcasts

PELLENTESQUE HABITANT MORBI TRISTIQUE SENECTUS ET NETUS ET MALESUADA FAMES AC
TURPIS EGESTAS VESTIBULUM TORTOR QUAM.

Let's have a conversation

E-learning courses
User group webcasts

Let's have a conversation

E-learning courses
User group webcasts

Let's have a conversation

CONSIDERATIONS WHEN SELECTING A POWDERED HEMOSTAT1,19

Arista™ AH Absorbable Hemostatic Particles SURGICEL® Powder Right sizing: Cost
effective and reduces waste 3 sizes: 1 g, 3 g, 5 g 1 size: 3 g Economic Shelf
life and storage 5 year shelf life. Arista™ AH should be stored to avoid
temperature extremes (less than -40°C [-40°F] and greater than 60°C [140°F]). 18
month shelf life. Store at controlled room temperature 15°C-30°C (59°F-86°F).
Tip delivery system FlexiTip™ XL applicator, includes (1) applicator (length: 38
cm)
FlexiTip™ XL-R applicator, rigid, 38 cm
FlexiTip™ XL applicator, includes (2) applicators (length: 14 cm) SURGICEL®
Endoscopic Applicator Patient’s coagulation status Arista™ AH begins the
clotting process on contact, regardless of the patient’s coagulation status. No
data available. 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. Contraindication: When SURGICEL® Powder is used to help achieve
hemostasis in, around, or in proximity to foramina in bone, areas of bony
confine, the spinal cord, or the optic nerve and chiasm, it must always be
removed after hemostasis is achieved since it will swell and could exert
unwanted pressure. Adhesion formation No warnings or contraindications. Warning:
SURGICEL® Powder is dry and there may be difficulties in precise delivery under
certain circumstances. Unintentional device placement may result in powder
scattering and device migration that may increase the risk of adhesion
formation. Cell saver compatibility Arista™ AH is a cell saver compatible
hemostat. SURGICEL® Powder should not be used in conjunction with autologous
blood salvage circuits, because its fragments may pass through the transfusion
filters of blood-scavenging systems. Laparoscopic and endoscopic use Available
with a FlexiTip™ XL-R applicator for endoscopic / laparoscopic procedures. The
SURGICEL™ Endoscopic Applicator is supplied with a flexible inner tip inserted
into a rigid cannula. It is intended to be used only with the SURGICEL® Powder
absorbable hemostat. The SURGICEL™ Endoscopic Applicator is for single use only
and must be discarded after use. Procedure Urological procedures Precaution: In
urological procedures, Arista™ AH should not be left in the renal pelvis or
ureters to eliminate the potential foci for calculus formation. Precaution: In
uroglogical procedures, minimal amounts of SURGICEL® Powder should be used and
care must be exercised to prevent plugging of the urethra, ureter, or a catheter
by dislodged portions of the product. ENT use No warnings, contraindications or
adverse events directly related to ENT use. Adverse reaction: Burning has been
reported with other SURGICEL® products were applied after nasal polyp removal.
Headache, burning, stinging, and sneezing in epistaxis and other rhinological
procedures, and stinging when SURGICEL® product was applied on surface wounds
(varicose ulcerations, dermabrasions, and donor sites) have also been reported.
Absorption profile Arista™ AH absorption time: approximately 24–48 hours.
ASURGICEL® Powder fully absorbs within 7 to 14 days. When used properly in
minimal amounts, SURGICEL® Powder is absorbed from the sites of implantation
with practically no tissue reaction. Absorption depends on several factors,
including the amount used, degree of saturation with blood, and the tissue bed.
Product Method of action Arista™ AH particles are hydrophilic molecular sieves
that enhance natural hemostasis by concentrating blood solids such as platelets,
red blood cells, and blood proteins on the particle surfaces to form a gelled
matrix. The concentrated gel matrix provides a barrier to further blood loss and
is formed regardless of the patient’s coagulation status. The concentration of
clotting factors and platelets in the gel serves to enhance normal clotting
reactions and creates stable hemostatic plugs. The absorption process begins
immediately and is dependent on several factors, including the amount applied
and site of use. The mechanism of action whereby SURGICEL® Powder (oxidized
regenerated cellulose) accelerates clotting is not completely understood, but it
appears to be a physical effect rather than any alteration of the normal
physiologic clotting mechanism. After SURGICEL® Powder has been saturated with
blood, it swells into a brownish or black gelatinous mass which aids in the
formation of a clot, thereby serving as a hemostatic adjunct in the control of
local hemorrhage. Foreign body 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 Foreign body reactions have been
reported with other products from the SURGICEL® Family of Absorbable Hemostats.

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REFERENCES

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.

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.
v 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.

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