aquamantys surgical oncology solutions - medeltip.com · aquamantys® surgical oncology solutions....

Aquamantys® SurgicalOncology Solutions

Medtronic’s advanced energy products deliver proprietary Transcollation® technology for hemostatic sealing of softtissue and bone. Our Aquamantys® System is used across a wide range of surgical procedures, including orthopaedicreconstruction, spine surgery, orthopaedic trauma, and surgical oncology. More than 650,000 patients have beentreated with Transcollation technology since 1999, and our products are used in:

• 15 of the top 17 hospitals in the US News & World Report 2011-2012 Honor Roll of “America’s Best Hospitals” 1

• 8 of the top 10 US cancer hospitals1

The Aquamantys System combines radiofrequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management products.2

• Liver resections• Pancreatectomies• Partial nephrectomies

• Reduces transfusion rates during and after liver resections2

• May reduce the need for other blood management products during or after the procedure2

• Reduces need for renal clamping in partial nephrectomies3

• May reduce post-operative pancreatic leaks following distal pancreatectomy4,5

Advanced Energy

UNIQUE TECHNOLOGY

SUrGICaL ONCOLOGY aPPLICaTIONS

CLINICaL BENEFITS

Transcollation® technology reduces transfusion rates,2 which in turn may lower costs to the hospital.6,7 Transfusions can add up to $2000 in total costs for a patient during the course of an inpatient hospital stay, as illustrated in the tables below.

1. U.S. News & World Report - Best Hospital Rankings, 2011-2012. http://health.usnews.com/best-hospitals.2. Geller DA, Tsung A, Maheshwari V, Rutstein LA, Fung JJ, Marsh JW. Hepatic resection in 170 patients using saline-cooled radiofrequency coagulation. HPB 2005; 7: 208–213.3. Urena R, Mendez F, Woods M, Thomas R, Davis R. Laparoscopic partial nephrectomy of solid renal masses without hilar clamping using monopolar radiofrequency device.

Journal of Urology, 2004; 171(3):1054-6.4. Performance has been demonstrated in a pre-clinical model.5. Truty MJ, Sawyer MD, Que FG. Decreasing pancreatic leak after distal pancreatectomy: saline-coupled radiofrequency ablation in a porcine model. Gastrointest Surg 2007;

1:998-1007.6. Covance report; 2009 MedPAR database based on ICD-9-CM Codes for 100% of Medicare beneficiaries.7. Performance has not been specifically established with the Aquamantys System.8. Covance MedPAR report; length of stay has not been specifically correlated with the Aquamantys System.

References

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Caution: Federal Law (USA) restricts these devices to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, and warnings, please refer to the Instructions For Use (IFU) that accompany Aquamantys disposable devices and/or the Aquamantys System User Guide.

Medtronic Advanced Energy, LLCMedtronic USA, Inc.180 International DrivePortsmouth, NH 03801USAwww.medtronic.com/advancedenergyTel: (866) 777-9400Fax: (866) 222-0900

For further information, please call 866-777-9400.You may also consult our website:www.medtronic.com/advancedenergy

ECONOMIC VaLUE

TaBLE 2

Average hospital length of stay for liversurgery with and without a transfusion6,8

TaBLE 1

Average costs of liver surgery with and without a transfusion6,7

With Transfusion Without Transfusion With Transfusion Without Transfusion

0

$51K

9.00

7.00

$49K$50,000

$40,000

$30,000

$20,000

$10,000

8

10

6

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2

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Aquamantys® Systemand Transcollation® Technology

The Aquamantys System delivers patented Transcollation technology to quickly stop bleeding and reduce blood loss during

and after surgery.1-4 Transcollation technology is a combination of radiofrequency (RF) energy and saline that provides

hemostatic sealing of soft tissue and bone. It has been clinically shown to lower transfusion rates and may reduce the need

for other blood management products during and after surgery.5

• Reduces transfusion rates during and after liver resections5

• May reduce the need for other blood management products during or after the procedure5

• Reduces need for renal clamping in partial nephrectomies6

• May reduce post-operative pancreatic leaks following distal pancreatectomy7,8

Step 3Vessels <1 mm may be occluded, reducing bleeding

Step 1 RF energy and saline is applied to tissue

Step 2 Heat-induced shrinkage occurs

Transcollation technology integrates RF energy and

saline to deliver controlled thermal energy to tissue. The

coupling of saline and RF energy allows the device

temperature to stay at approximately 100°C – nearly

200°C less than conventional devices. This produces a

tissue effect without the associated charring found in

other methods.

Hemostatic Sealing of Soft Tissue and Bone to Reduce Blood Loss

HOW IT WORKS

OVERVIEW

KEY BENEFITS

1. Performance has not been specifically established in all procedures.2. Marulanda GA, Ulrich SD, et al. Reductions in blood loss with a bipolar sealer in total hip arthroplasty. Expert Rev Med Devices 2008; 5:125-131.3. Marulanda GA, Krebs VE, et al. Hemostasis using a bipolar sealer in primary unilateral total knee arthroplasty. American Journal of Orthopedics 2009; 38(12):E179-183. 4. Mankin KP, Moore CA, Miller LE, Block JE. Hemostasis with a bipolar sealer during surgical correction of adolescent idiopathic scoliosis. E-published in Journal of Spinal

Disorders & Techniques, October 2011. doi:10.1097/BSD.0b013e3182334ec5.5. Geller DA, Tsung A, Maheshwari V, Rutstein LA, Fung JJ, Marsh JW. Hepatic resection in 170 patients using saline-cooled radiofrequency coagulation. HPB 2005; 7: 208–213.6. Urena R, Mendez F, Woods M, Thomas R, Davis R. Laparoscopic partial nephrectomy of solid renal masses without hilar clamping using monopolar radiofrequency device.


1:998-1007.

References




Aquamantys® Pump Generator Placement Overview

The Aquamantys System consists of a multi-use pump generator and single-use disposable handpieces. Through

our no-charge placement agreement, Medtronic provides the generator to the customer at no cost. In addition, the

customer agrees to purchase as needed the disposable handpieces used during each procedure.

•TheAquamantysPumpGeneratorremainsanassetofMedtronic

•TheAquamantysPumpGeneratorisplacedinthehospitalunderano-chargeplacementagreement

•Medtronicperformsallrequiredservicingofthegenerator

•Thereareno:

- Monthly usage fees

- Incremental charges on disposable instruments

- Minimum disposable purchase requirements for use

of the generator(s)

Please contact your local sales representative for additional

information and details.

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Aquamantys® System’sClinical Value in Surgical Oncology Procedures

The Aquamantys System uses Transcollation® technology, which provides broad tissue-surface hemostasis in a rapid and controlled manner. Transcollation technology has been clinically proven to reduce transfusion rates during and after surgery.1 MedPAR data has shown that reduced transfusion rates contribute to lower costs for hospitals2 and reduced length of stay for patients.3

CliniCal Benefits

- Reduces blood transfusions during and after liver resections1

- Reduces need for renal clamping in partial nephrectomies4

- May reduce post-operative pancreatic leaks following distal pancreatectomy5,6

- May reduce the need for other blood management products before or after the procedure1

- Reduces transfusion rates,1 which in turn may lower costs to the hospital2,7

eConomiC Benefits Patient Benefits

- Reduces transfusion rates during and after liver resections1

- Reduced transfusion rates may prevent related post-operative complications, thus reducing hospital length of stay1,3

References




1. Geller DA, Tsung A, Maheshwari V, Rutstein LA, Fung JJ, Marsh JW. Hepatic resection in 170 patients using saline-cooled radiofrequency coagulation. HPB 2005; 7:208–213.2. Covance report; 2009 MedPAR database based on ICD-9-CM Codes for 100% of Medicare beneficiaries.3. Covance MedPAR report; length of stay has not been specifically correlated with the Aquamantys System.4. Urena R, Mendez F, Woods M, Thomas R, Davis R. Laparoscopic partial nephrectomy of solid renal masses without hilar clamping using monopolar radiofrequency device.


1:998-1007. 7. Performance has not been specifically established with the Aquamantys System.

Transcollation® technology combines radiofrequency (RF) energy and saline for hemostatic sealing of soft tissue and bone at the surgical site. Vessels up to 1 mm

in diameter may be occluded, reducing bleeding.

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Aquamantys® System’sEconomic Value: Lowering Costs by Simplifying Hemostasis

Transcollation® technology achieves hemostasis during liver surgery, resulting in reduced transfusion rates.1 Using Transcollation technology during surgical oncology procedures may also reduce the need for other blood management products such as topical hemostats and energy-based devices.1 Blood transfusions add costs to surgical procedures through both the direct cost of blood products and the associated increase in average length of stay (LOS) as shown in the tables below.

Table 1

Average costs of liver surgery with and without a transfusion2,3

With Transfusion Without Transfusion

Table 2

Average LOS of liver surgery with and without a transfusion2,4

With Transfusion Without Transfusion

$51k

9.00

7.00

$49k

$40,000

$50,000

$30,000

$20,000

$10,000

0

8

10

6

Day

s

4

2

0

1. Geller DA, Tsung A, Maheshwari V, Rutstein LA, Fung JJ, Marsh JW. Hepatic resection in 170 patients using saline-cooled radiofrequency coagulation. HPB 2005; 7: 208–213.2. Performance has not been specifically established with the Aquamantys System.3. Covance report; 2009 MedPAR database based on ICD-9-CM Codes for 100% of Medicare beneficiaries. Data on file.4. Covance MedPAR report; length of stay has not been specifically correlated with the Aquamantys System.5. Bierbaum BE, et al. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am 1999; 81:2-10.

References




Aquamantys® System’s Impact on Transfusion Rates and Blood LossTransfusions are known to be one of the factors to increase the likelihood of post-surgical complications3 and frequently contribute to increased length of stay.2,5 Transcollation® technology has been clinically shown to reduce blood transfusion rates during and after liver resections.1

Economic Impact of Aquamantys System on Procedure Costs

By reducing transfusion rates, the Aquamantys® System may reduce or eliminate other methods of blood management such as energy-based devices and topical hemostats.1

Medtronic can help you create a customized economic analysis. Please contact your local sales representative for more information.

MedPAR national averagetransfusion rates3

Transfusion rates withTranscollation® technology1

23.2%

3.5%

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Select Surgical Oncology Publications

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 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.

In a pre-clinical study, three Mayo Clinic surgeons reduced post-op pancreatic leaks to 5.5% in the group treated with Transcollation technology compared to 42% in the control group.

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): 578-82.

Decreasing Pancreatic Leak after Distal Pancreatectomy: Saline-coupled Radiofrequency Ablation in a Porcine Model. Truty MJ, Sawyer MD, Que FG. J Gastrointest Surg 2007; 1:998-1007.

Hepatic Resection in 170 Patients Using Saline-cooled Radiofrequency Coagulation. Geller DA, Tsung A, Maheshwari V, Rutstein LA, Fung JJ, Marsh JW. HPB 2005; 7: 208–213.




Surgical Oncology Bibliography

Kawashita Y, Iwata T, Kanetaka K, Ono S, Kawahara Y, Fujisawa H, Yoshida T, Miyahara S, Eto S, Kanematsu T. Laparoscopy-assisted right hepatectomy in a case of Fasciola hepatica. Surg Laparosc Endosc Percutan Tech. 2011 Feb;21(1):e54-8.

Kobayashi S, Nagano H, Marubashi S, Wada H, Eguchi H, Takeda Y, Tanemura M, Sekimoto M, Doki Y, Mori M. A single-incision laparoscopic hepatectomy for hepatocellular carcinoma: initial experience in a Japanese patient. Minim Invasive Ther Allied Technol. 2010 Dec;19(6):367-71.

Lee KF, Wong J, Ng W, Cheung YS, Lai P. Feasibility of liver resection without the use of the routine Pringle manoeuver: an analysis of 248 consecutive cases. HPB (Oxford). 2009 Jun;11(4):332-8.

El Moghazy WM, Hedaya MS, Kaido T, Egawa H, Uemoto S, Takada Y. Two different methods for donor hepatic transection: Cavitron Ultrasonic Surgical Aspirator with bipolar cautery versus Cavitron Ultrasonic Surgical Aspirator with radiofrequency coagulator–A randomized controlled trial. Liver Transpl. 2009 Jan;15(1):102-5.

Kaneko H, Otsuka Y, Tsuchiya M, Tamura A, Katagiri T, Yamazaki K. Application of devices for safe laparoscopic hepatectomy. HPB (Oxford). 2008;10(4):219-24.

Xia F, Wang S, Ma K, Feng X, Su Y, Dong J. The use of saline-linked radiofrequency dissecting sealer for liver transection in patients with cirrhosis. J Surg Res. 2008 Sep;149(1):110-4.

McGahan JP, Khatri VP. Imaging findings after liver resection by using radiofrequency paren-chymal coagulation devices: initial experiences. Radiology. 2008 Jun;247(3):896-902.

Wøjdemann M, Riber C, Burcharth F. [New liver surgery techniques. Few complications and more advantages?]. Ugeskr Laeger. 2008 Apr 14;170(16):1342-5. Danish.

Poon RT. Current techniques of liver transection. HPB (Oxford) 2007;9(3):166-73.

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):208-13.

Hutchins R, Bertucci M. Experience with TissueLink--radiofrequency-assisted parenchymal division. Dig Surg. 2007;24(4):318-21.

Coleman J, Singh A, Pinto P, Phillips J, Pritchard W, Wray-Cahen D, Wood BJ. Radiofrequency-assisted laparoscopic partial nephrectomy: clinical and histologic results. J Endourol. 2007 Jun;21(6):600-5.

Truty MJ, Sawyer MD, Que FG. Decreasing pancreatic leak after distal pancreatectomy: saline-coupled radiofrequency ablation in a porcine model. J Gastrointest Surg. 2007 Aug;11(8):998-1007.

Wei W, Guo RP, Shi M, Zhong C, Yu WS, Li JQ. [The value of TissueLink hemostatic sealer in hepatectomy for hepatocellular carcinoma]. Ai Zheng. 2006 Nov;25(11):1443-6. Chinese.

Passariello M, Almenrader N, Coccetti B. Hyperthermia during surgery with TissueLink. Paediatr Anaesth. 2006 Oct;16(10):1099-100.

Di Carlo I, Sofia M, Toro A, Barbagallo F, Guastella G. [Colorectal liver metastases resected with safe margin achieved by Tissuelink Monopolar Floating Ball]. Suppl Tumori. 2005 May-Jun;4(3):S37-8. Italian.

Di Carlo I, Toro A, Sofia M, Sparatore F, Galia A, Vasta D, Patanè D, Malfa PA, Corsale G, Siciliano R. [Use of the Floating Ball for hepatic resection in cirrhotic patients affected by hepatocel-lular carcinoma]. G Chir. 2005 Aug-Sep;26(8-9):321-7. Italian.

Fioole B, van der Bilt JD, Elias SG, de Hoog J, Borel Rinkes IH. Precoagulation minimizes blood loss during standardized hepatic resection in an experimental model. Br J Surg. 2005 Nov;92(11):1409-16.

Clayman RV. TissueLink device for laparoscopic nephron-sparing surgery. J Urol. 2005 Oct;174(4 Pt 1):1248-9.

Cuschieri A. Laparoscopic liver resections. J Minim Access Surg. 2005 Sep;1(3):99-109.

Sprunger J, Herrell SD. Partial laparoscopic nephrectomy using monopolar saline-coupled radiofrequency device: animal model and tissue effect characterization. J Endourol. 2005 May;19(4):513-9.

Herrell SD, Levin BM. Laparoscopic partial nephrectomy: use of the TissueLink hemostatic dissection device. J Endourol. 2005 May;19(4):446-9; discussion 449-50.

Vanlangendonck R, Venkatesh R, Vulin C, Quayle S, Morrissey K, Landman J. Laparoscopic ureterocalicostomy: development of a technique simplified by application of Nitinol clips and a wet monopolar electrosurgery device. J Endourol. 2005 Mar;19(2):225-9.

Ilbeigi P, Ahmed M, Szobota J, Munver R, Sawczuk IS. Open partial nephrectomy using saline-enhanced monopolar radiofrequency device: evaluation of novel surgical technique with TissueLink DS3.0 Dissecting Sealer. Urology. 2005 Mar;65(3):578-82.

Tan YH, Young MD, L’Esperance JO, Preminger GM, Albala DM. Hand-assisted laparoscopic partial nephrectomy without hilar vascular clamping using a saline-cooled, high-density monopolar radiofrequency device. J Endourol. 2004 Nov;18(9):883-7.

Stern JA, Simon SD, Ferrigni RG, Andrews PE. TissueLink device for laparoscopic nephron-sparing surgery. J Endourol. 2004 Jun;18(5): 455-6.

Di Carlo I, Barbagallo F, Toro A, Sofia M, Guastella T, Latteri F. Hepatic resections using a water-cooled, high-density, monopolar device: a new technology for safer surgery.J Gastrointest Surg. 2004 Jul-Aug;8(5):596-600.

Topp SA, McClurken M, Lipson D, Upadhya GA, Ritter JH, Linehan D, Strasberg SM. Saline-linked surface radiofrequency ablation: factors affecting steam popping and depth of injury in the pig liver. Ann Surg. 2004 Apr;239(4):518-27.

Urena R, Mendez F, Woods M, Thomas R, Davis R. Laparoscopic partial nephrectomy of solid renal masses without hilar clamping using a monopolar radio frequency device. J Urol. 2004 Mar;171(3):1054-6.

Simon SD, Ferrigni RG, Novicki DE, Lamm DL, Swanson SS, Andrews PE. Mayo ClinicScottsdale experience with laparoscopic nephron sparing surgery for renal tumors. J Urol. 2003 Jun;169(6):2059-62.

Sundaram CP, Rehman J, Venkatesh R, Lee D, Rageb MM, Kibel A, Landman J. Hemostatic laparoscopic partial nephrectomy assisted by a water-cooled, high-density, monopolar device without renal vascular control. Urology. 2003 May;61(5):906-9.

Lin E, Gonzalez R, Venkatesh KR, Mattar SG, Bowers SP, Fugate KM, Heffron TG, Smith CD. Can current technology be integrated to facilitate laparoscopic living donor hepatectomy? Surg Endosc. 2003 May;17(5):750-3. Epub 2003 Mar 6.

Yim AP, Rendina EA, Hazelrigg SR, Chow LT, Lee TW, Wan S, Arifi AA. A new technological approach to nonanatomical pulmonary resection: saline enhanced thermal sealing. Ann Thorac Surg. 2002 Nov;74(5):1671-6.

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Please note that facilities on this list currently use Transcollation technology in at least one specialty, but not necessarily in all specialties.

15 of the top 17 hospitals in the US News & World Report 2011-2012 Honor Roll of “America’s Best Hospitals” are using Transcollation technology1

Johns Hopkins Hospital, Baltimore, MD

Massachusetts General Hospital, Boston, MA

Mayo Clinic, Rochester, MN

Cleveland Clinic, Cleveland, OH

Ronald Reagan UCLA Medical Center, Los Angeles, CA

New York-Presbyterian University Hospital of Columbia and Cornell, New York, NY

University of California, San Francisco Medical Center, San Francisco, CA

Duke University Medical Center, Durham, NC

Hospital of the University of Pennsylvania, Philadelphia, PA

Barnes-Jewish Hospital/Washington University, St. Louis, MO

UPMC-University of Pittsburgh Medical Center, Pittsburgh, PA

University of Michigan Hospitals and Health Centers, Ann Arbor, MI

Vanderbilt University Medical Center, Nashville, TN

Mount Sinai Medical Center, New York, NY

Stanford Hospital and Clinics, Stanford, CA

Top Hospitals Using Transcollation® Technology

References

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8 of the top 10 Hospitals for Cancer in “America’s Best Hospitals” from US News & World Report are using Transcollation® technology1

University of Texas M.D. Anderson Cancer Center, Houston, TX

Memorial Sloan-Kettering Cancer Center, New York, NY

Johns Hopkins Hospital, Baltimore, MD

Mayo Clinic, Rochester, MN

Massachusetts General Hospital, Boston, MA

University of California, San Francisco Medical Center, San Francisco, CA

Cleveland Clinic, Cleveland, OH

Ronald Reagan UCLA Medical Center, Los Angeles, CA

1. U.S. News & World Report - Best Hospital Rankings, 2011-2012. http://health.usnews.com/best-hospitals.



Caution: Federal Law (USA) restricts these devices to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, and warnings, please refer to theInstructions For Use (IFU) that accompany Aquamantys disposable devices and/or the Aquamantys System User Guide.

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aquamantys surgical oncology solutions - medeltip.com · aquamantys® surgical oncology solutions....

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