71 10 2438 Rev B Aquamantys System Brochure
2014-12-17
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Aquamantys® System
HELPING SURGEONS ACHIEVE HEMOSTASIS
Advanced Energy
Medtronic Advanced Energy is dedicated to developing
technology that provides benets to surgeons and their
patients. Our Aquamantys® System uses proprietary
Transcollation® technology, a combination of radio frequency
(RF) energy and saline, to provide hemostatic sealing of soft
tissue and bone during surgery.
The Aquamantys System delivers Transcollation technology
through an electrosurgical generator and handheld
disposable devices. These products are used across a wide
range of specialties, including spine surgery, orthopaedic
reconstruction, orthopaedic trauma and surgical oncology.
Aquamantys products are currently used in all of the top 18
hospitals listed in the U.S. News & World Report 2013-2014
Honor Roll of “America’s Best Hospitals.”1
Unique Technology
The combination of saline and RF energy in Transcollation
technology allows the device temperature to stay at
approximately 100°C – nearly 200°C less than traditional
devices. The lower device temperature produces a tissue
eect without the associated smoke and charring found in
other methods.
Step 3
Vessels up to 1 mm in diameter may be occluded
Step 1
RF energy and saline are applied to tissue
Step 2
Heat-induced shrinkage occurs
Hemostatic Sealing of Soft Tissue and
Bone to Reduce Blood Loss
1. Shoulder
3. Spine
2. Thoracic
4. Surgical Oncology
5. Hip
6. Muskuloskeletal Oncology
5
8
7
1
6
3
4
2
7. Knee
8. Trauma
Surgical Applications
Below is a list of surgical applications in which Transcollation® technology is commonly used.
Product Overview
Aquamantys® System
The Aquamantys System addresses the need of surgeons to achieve hemostasis during surgery.
It consists of a multi-use pump generator and single-use disposable handpieces.
2.3 Bipolar Sealer
Medium-sized electrodes provide more precise
application for hemostatic sealing
6.0 Bipolar Sealer
Large-sized electrodes provide hemostatic
sealing
of bleeding soft tissue and bone
Aquamantys Generator
Delivers Transcollation® technology,
with power settings from 20-200 watts
and 3 dierent ow rate settings
MBS Malleable Bipolar Sealer
with Light
Malleable shaft and built-in light allow access to
dicult-to-reach anatomy and provide illumination
during surgery
9.5 XL Bipolar Sealer
Cone-shaped electrode design aids in blunt
dissection and hemostatic sealing
Endo DBS 8.7 Dissecting
Bipolar Sealer
Laparosopic length device enables minimally
invasive procedures, with cone-shaped electrodes
to aid in blunt dissection
Please note that some devices are available on both Aquamantys and Aquamantys3 platforms. See ordering information for details (page 11).
Product Overview
Aquamantys®3 System
The Aquamantys3 System is the only multifunctional advanced energy platform that
combines Transcollation® technology with monopolar cutting functionality.
SBS 5.0 Sheathed Bipolar Sealer
Retractable sheath enables simultaneous retraction
and electrode use near sensitive tissue such as dura
and nerve roots (sheath closed) and hemostatic
sealing of soft tissue and bone (sheath open)
EVS Epidural Vein Sealer
Insulated shaft enables electrode use near sensitive
tissue such as dura and nerve roots
Mini EVS 3.4 Epidural Vein Sealer
3.4mm tip size for small epidural access points, and
insulated shaft enables simultaneous retraction
and electrode use near sensitive tissue such as dura
and nerve roots
Aquamantys3 Generator
Combines Transcollation technology and
electrosurgical cutting with a touch
screen interface and automatic hand-
piece recognition for optimized settings
BSC 9.1 Bipolar Sealer
with Cutting
Combines the benets of Transcollation technology
with monopolar electrosurgical cutting
8.2L Bipolar Sealer with Cutting
Combines Transcollation technology with monopolar
electrosurgical cutting
Clinical
-Reduces transfusion rates by
minimizing intra-operative
blood loss2-5
-Prevents and stops epidural
bleeding near critical
structures6,*
-May reduce post-operative
pancreatic leaks following distal
pancreatectomy7,*
Patient
-Reduces transfusion rates;2-5
reduced transfusions contribute
to reduced hospital length of
stay
8,**
-Helps to maintain hemoglobin
levels2,10,*
-May decrease complications
and reduce post-operative
patient morbidity4,*
Economic
-Reduces transfusion rates;2-5
reduced transfusions in turn
may lower costs to the hospital8,**
-Decreases surgical time9,*
-May reduce the need for other
hemostatic agents5,*
Benets
Economic Value
Transcollation® technology is an important evolution in providing hemostasis for patient care. We recognize that healthcare
providers have several options for managing patient blood loss perioperatively in conjunction with budget management.
Clinical studies have shown that using the Aquamantys® System results in reduced blood loss and transfusion rates.2-5
Transfusions have been directly linked to additional hospital costs and length of stay (LOS).8,**
Tables 1 and 2 below
represent
hospital national-average costs and LOS for surgery with and without a transfusion based on MedPAR data.
Medtronic is committed to delivering improved clinical outcomes while saving money for hospitals. We can work with
your
institution to create a customized economic analysis. Contact your local sales representative for additional information.
Table 2
Mean LOS with and
without a transfusion8
5.67
4.27
5.45
9.00
4.79
3.53
4.53
7.00
8
10
6
4
2
0
Days
Hip Knee Spine Liver
With Transfusion Without Transfusion
Table 1
With Transfusion Without Transfusion
Average costs with and
without a transfusion8
$18k $17k
$32k
$51k
$16k $14k
$29k
$49k
$40,000
$50,000
$30,000
$20,000
$10,000
0Hip Knee Spine Liver
Clinical Publications and Results
Hip
Bipolar sealing in revision total hip
arthroplasty for infection: ecacy and
cost analysis. Kamath AF, Clement RC,
Derman PB, Garino JP, Lee GC. J Arthroplasty.
2012;27(7):1376-1381.
This study reviewing infected hip revision procedures demonstrated signicantly lower total
blood loss (998 mL vs. 1330 mL; p=0.038), change in hemoglobin (2.32 units vs. 3.99 units;
p=0.013) and OR time (134 min vs. 157.5 min; p=0.039) in the bipolar sealer group with a
cost-neutral to cost savings of $1300 based on OR space allocation.
Comparison of unilateral and rapidly
staged bilateral resurfacing arthroplasty.
Gross TP, Lu F, Webb L. Acta Orthop Belg. 2011;
77(2):203-210.
This study demonstrated that when a bipolar sealer is used as part of a comprehensive
blood management program, the following benets may be observed: (1) may be more
eective for preventing blood transfusion than a cell saver; and (2) may contribute
to minimizing cost and complications associated with intra-operative blood loss and
transfusions.
Marulanda et al. demonstrated a statistically signicant dierence in intra-operative
(p=0.002 andn
post-operative (p=0.001) blood loss using the Aquamantys® System. They
also demonstrated a reduction in both allogeneic and autologous transfusion rates from
28% to 23% and 24% to 12% respectively. Transfusions overall were signicantly reduced
from 53% to 20% (p=0.005).
Reductions in blood loss with a bipolar
sealer in total hip arthroplasty. Marulanda
GA, Ulrich SD, Seyler TM, Delanois RE, Mont MA.
Expert Rev Med Devices. 2008;5(2):125-131.
Numerous authors have reported on the clinical outcomes associated with the use of Transcollation® technology
in orthopaedic reconstruction, spine, and surgical oncology procedures. These studies have shown the use of
Transcollation technology to be associated with reduction in blood loss and transfusion rates.2-5 The following list
outlines some relevant study results.
Hemostasis using a bipolar sealer in
primary unilateral total knee arthroplasty.
Marulanda GA, Krebs VE, Bierbaum BE, et al.
Am J Orthop (Belle Mead NJ). 2009;
38(12):E179-183.
This multi-center prospective randomized trial demonstrated that the amount of blood
loss and decrease in post-operative hemoglobin were signicantly lower in the bipolar
sealer group (p=0.0073 and p=0.0417 respectively).
Knee
Marulanda et al. in a 50 patient study demonstrated a signicant reduction in post-
operative and total blood loss in the bipolar sealer group (p=0.05 and p=0.02,
respectively), as well as an absence of tissue charring and smoke production.
Reductions in blood loss with use of a
bipolar sealer for hemostasis in primary
total knee arthroplasty. Marulanda GA,
Ragland PS, Seyler TM, Mont MA. Surg Technol
Int. 2005;14:281-286.
Aquamantys bipolar sealer in primary total
knee arthroplasty: experience with 3,172
consecutive knee replacements. Sah A,
Dearborn J. Poster presentation at American
Academy of Orthopaedic Surgeons Annual
Meeting. 2012; San Francisco, CA.
This study of sample size 3,172 in the bipolar sealer group and 667 in the electrocautery
group demonstrated several benets in the bipolar sealer group, including signicantly
lower knee drainage output (807 mL vs. 1290 mL; p<0.0001), a statistically higher
hematocrit at discharge (31.5 vs. 30.2; p<0.001), and a reduction in transfusions from
10% to 3%.
Clinical Publications and Results
Hepatic resection in 170 patients using saline-
cooled radiofrequency coagulation. Geller
DA, Tsung A, Maheshwari V, Rutstein LA, Fung JJ,
Marsh JW. HPB (Oxford). 2005;7:(3)208-213.
In a study of 170 patients at the University of Pittsburgh Medical Center, Geller et
al. reduced transfusion rates for liver resections to 3.5% when using Transcollation®
technology compared to published averages of 15-33% for large institutions.
Surgical Oncology
Open partial nephrectomy using saline-
enhanced monopolar radiofrequency device:
evaluation of novel surgical technique with
TissueLink DS3.0 dissecting sealer. Ilbeigi
P, Ahmed M, Szobota J, Munver R, Sawczuk IS.
Urology. 2005;65(3):578-582.
In a study of 22 open partial nephrectomies with hilar occlusion, data showed a 30-35%
(p=0.07) reduction in blood loss in the 11 cases treated with Transcollation technology.
In this retrospective study of 62 patients who underwent distal pancreatectomies
between 2002-2011, the results demonstrated a 75% decrease in post-operative leak
rates. When Transcollation technology was used, 10% of patients experienced leaks,
compared with 36% of patients with traditional stump closure methods.
Novel method of stump closure for distal
pancreatectomy with a 75% reduction in
pancreatic stula rate. Blanseld JA, Rapp
MM, Chokshi RJ, et al. J Gastrointest Surg. 2012;
16(3):524-528.
Spine
In this retrospective study of 100 patients undergoing posterior spinal fusion for idiopathic
scoliosis, baseline characteristics between groups were similar except for the number of
levels fused, which was larger in the bipolar sealer group. The results showed that bipolar
sealer patients experienced statistically signicantly lower total peri-operative blood
loss including post-op drain output, intra-operative cell saver transfusion volume, intra-
operative or post-operative transfusion rate, and total blood volume transfused.
Use of bipolar sealer device reduces blood
loss and transfusions in posterior spinal
fusion for adolescent idiopathic scoliosis.
Gordon Z, Son-Hing JP , Poe-Kochert
C, Thompson GH. J Pediatr Orthop.
2013;33(7):700-706.
Hemostasis with a bipolar sealer during
surgical correction of adolescent
idiopathic scoliosis. Mankin KP, Moore CA,
Miller LE, Block JE. J Spinal Disord Tech. 2012;
25(5):259-263.
During posterior spinal fusion surgery for deformity, this study showed a signicant
decrease in estimated blood loss in the bipolar sealer group whether measured in total
(435 ± 192mL, compared with 1009 ± 392 mL in the control group; p<0.001) or per level
fused (39 ± 17 mL, compared with 95 ± 33 mL in the control group; p<0.001). In turn, this
decreased blood loss resulted in a signicantly reduced risk of transfusion (p=0.014).
Bipolar sealing technology to control
bleeding in pediatric spine surgery: a
retrospective study. Snyder BD, Hedequist
D, Shannon E. Poster presentation at Pediatric
Orthopaedic Society of North America Annual
Meeting. 2007;Hollywood, FL.
This 42 patient study in severe neuromuscular scoliosis demonstrated a reduced
operative blood loss, a decrease in the amount of blood transfused, and reduction in
overall operative time when the bipolar sealer was used as an adjunct to the author’s
conventional blood management strategy.
Top Hospitals
Johns Hopkins Hospital
Baltimore, MD
Massachusetts General Hospital
Boston, MA
Mayo Clinic
Rochester, MN
Cleveland Clinic
Cleveland, OH
UCLA Medical Center
Los Angeles, CA
Northwestern Memorial Hospital
Chicago, IL
New York-Presbyterian University Hospital of Columbia
and Cornell
New York, NY
UCSF Medical Center
San Francisco, CA
Brigham and Women’s Hospital
Boston, MA
UPMC-University of Pittsburgh Medical Center
Pittsburgh, PA
Hospital of the University of Pennsylvania
Philadelphia, PA
Duke University Medical Center
Durham, NC
Cedars-Sinai Medical Center
Los Angeles, CA
NYU Langone Medical Center
New York, NY
Barnes-Jewish Hospital/Washington University
St. Louis, MO
Indiana University Health Center
Indianapolis, IN
Thomas Jeerson University Hospital
Philadelphia, PA
University Hospitals Case Medical Center
Cleveland, OH
All of the top 18 hospitals in U.S. News & World Report’s 2013-2014 Honor Roll of “America’s
Best Hospitals” are using Transcollation® technology1
Please note that facilities on this list currently use Transcollation technology in at least one specialty but not necessarily in all specialties .
Ordering Information
Description Catalog Number
Aquamantys® 6.0 Bipolar Sealer ................................................................................................................................... 23-112-1
Aquamantys 2.3 Bipolar Sealer...................................................................................................................................... 23-113-1
Aquamantys EVS Epidural Vein Sealer ...................................................................................................................... 23-121-1
Aquamantys MBS Malleable Bipolar Sealer with Light .................................................................................. 23-301-1
Aquamantys SBS 5.0 Sheathed Bipolar Sealer ..................................................................................................... 23-312-1
Aquamantys 9.5 XL Bipolar Sealer ............................................................................................................................... 23-313-1
Aquamantys Mini EVS 3.4 Epidural Vein Sealer ................................................................................................... 23-314-1
Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer ..................................................................................... 23-317-1
Aquamantys Pump Generator ...................................................................................................................................... 40-402-1
Description Catalog Number
Aquamantys3 8.2L Bipolar Sealer with Cutting ................................................................................................. 25-102-1
Aquamantys3 BSC 9.1L Bipolar Sealer with Cutting ........................................................................................ 25-105-1
Aquamantys3 BSC 9.1S Bipolar Sealer with Cutting ........................................................................................ 25-106-1
Aquamantys3 6.0 Bipolar Sealer ................................................................................................................................... 23-305-1
Aquamantys3 2.3 Bipolar Sealer ................................................................................................................................... 23-306-1
Aquamantys3 MBS Malleable Bipolar Sealer with Light ............................................................................... 23-307-1
Aquamantys3 9.5 XL Bipolar Sealer ............................................................................................................................ 23-316-1
Aquamantys3 Pump Generator ................................................................................................................................... 40-404-1
© 2014 Medtronic Advanced Energy LLC. All rights reserved. Printed in USA. Aquamantys®, the Aquamantys®
logo, and Transcollation® are registered trademarks of Medtronic Advanced Energy LLC.
71-10-2438 2.14 Rev B
Medtronic Advanced Energy LLC
180 International Drive
Portsmouth, NH 03801
USA
www.medtronicadvancedenergy.com
Tel: (866) 777-9400
Fax: (866) 222-0900
For further information, please call 866-777-9400 or 603-742-1515.
You may also consult our website:
www.medtronicadvancedenergy.com
International Telephone Numbers
Adriatic Regional Oce 385-1-488-1120
Australia 1800-668-670
Baltic Regional Oce 37-1-67560226
Belgium 32-2456-09-09
Canada 1800-217-1617
China 86-21-50800998
Czech Republic 420-2-9657-9580
France 33-470-679-800
Germany 49-2159-8149-209
Greece 30-210-67-79-099
Hong Kong 852-2919-1312
Hungary 36-30-5052987
India 91-22-26836733
Israel 972-9-972-4400
Italy 39-02-24137-324
Japan 81-6-4795-1506
Korea 82-2-3404-3600
Lebanon 961-1-370-670
Luxembourg 32-2456-09-09
Netherlands 31-45-566-8800
Poland 48-22-465-6942
Russian Federation 7-495-580-73-77
Singapore 65-6776-6255
South Africa 27-11-466-1820
Spain 34-91-625-05-40
Taiwan 886-2-2183-6000
UK 44-1923-205-166
USA 1-603-742-1515
Rx only. For a listing of indications, contraindications, precautions, and warnings, please refer to the Instructions For Use (IFU) that accompany Aquamantys and Aquamantys3 disposable
devices and/or the Aquamantys and Aquamantys3 System User Guide.
References
1. U.S. News & World Report - Best Hospital Rankings, 2013-2014. http://health.usnews.com/best-hospitals. Data on le at Medtronic Advanced Energy.
2. Marulanda GA, Ulrich SD, Seyler TM, Delanois RE, Mont MA. Reductions in blood loss with a bipolar sealer in total hip arthroplasty. Expert Rev Med Devices. 2008;5(2):125-131.
3. Marulanda GA, Ragland PS, Seyler TM, Mont MA. Reductions in blood loss with use of a bipolar sealer for hemostasis in primary total knee arthroplasty. Surg Technol Int. 2005;14:281-286.
4. Mankin KP, Moore CA, Miller LE, Block JE. Hemostasis with a bipolar sealer during surgical correction of adolescent idiopathic scoliosis. J Spinal Disord Tech. 2012;25(5):259-263.
5. Geller DA, Tsung A, Maheshwari V, Rutstein LA, Fung JJ, Marsh JW. Hepatic resection in 170 patients using saline-cooled radiofrequency coagulation. HPB (Oxford). 2005;7(3):208-213.
6. Santiago P. Controlling epidural bleeding and improving visibility during spinal surgery with a novel bipolar sealing technology: a case report. Company funded, non-peer-reviewed
Medtronic white paper, 2009.
7. Blanseld JA, Rapp MM, Chokshi RJ, Woll NL, Hunsinger MA, Sheldon DG, Shabahang MM. Novel method of stump closure for distal pancreatectomy with a 75% reduction in
pancreatic stula rate. J Gastrointest Surg. 2012;16(3):524-528.
8. Covance report; 2008 MedPAR database based on ICD-9-CM Codes for 100% of Medicare beneciaries.
9. Snyder BD, Hedequist D, Shannon E. Bipolar sealing technology to control bleeding in pediatric spine surgery: a retrospective study. Poster presentation at Pediatric Orthopaedic
Society of North America Annual Meeting. 2007;Hollywood, FL.
10. Marulanda GA, Krebs Ve, Bierbaum BE, et al. Hemostasis using a bipolar sealer in primary unilateral total knee arthroplasty. Am J Orthop (Belle Mead NJ). 2009;38(12):E179-183.
* Performance has not been specically established in all procedures.
** Performance has not been specically established with the Aquamantys® System.
