aquamantys spine solutions - medeltip.com€™s advanced energy products deliver proprietary...

Aquamantys®

Spine Solutions

Medtronic’s advanced energy products deliver proprietary Transcollation® technology for hemostatic sealing of soft tissue and bone. Our Aquamantys® System is used across a wide range of surgical procedures, including orthopaedic reconstruction, spine surgery, orthopaedic trauma and surgical oncology. More than 650,000 patients have been treated with Transcollation technology since 1999. Our products are used in 14 of the top 17 hospitals listed in the U.S. News & World Report 2011-2012 Honor Roll of “America’s Best Hospitals.”1

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.2-4

• Posterior lumbar interbody fusion (PLIF)• Transforaminal lumbar interbody fusion (TLIF)• Anterior lumbar interbody fusion (ALIF)• Minimally invasive TLIF• Scoliosis surgery• Posterior cervical discectomy and fusion• Laminotomy, discectomy, decompression

• Reduces transfusion rates by minimizing intra-operative blood loss2-5

• May reduce the need for other blood management products during or after the procedure2,3

• Reduces post-operative incidence of hemarthrosis, which may lead to a reduction in pain and swelling3,6

• Successfully prevents and stops epidural bleeding near critical structures7

• Decreases surgical time and blood loss per level fused5,9,10

• May help improve visibility in the surgical field5,7,9

• Helps achieve hemostasis5

UNIQUE TECHNOLOGY

Advanced Energy

SPINE APPLICATIONS

CLINICAL VALUE

There are various methods currently employed to provide hemostasis during surgery. Tables 1 and 2 below represent hospital national-average costs for transfusions and length of stay (LOS) based on MedPAR data.10 Transcollation® technology reduces transfusion rates, which drives lower costs to the hospital.4,11

1. U.S. News & World Report - Best Hospital Rankings, 2011-2012. http://health.usnews.com/best-hospitals. 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. Performance has not been specifically established in all procedures.4. Marulanda GA, Krebs VE, et al. Hemostasis using a bipolar sealer in primary unilateral total knee arthroplasty. E-published in the American Journal of Orthopedics, 2009;

38(12):E179-183.5. 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.0b013e3182334ec5.6. Rosenberg AG. Reducing blood loss in total joint surgery with a saline-coupled bipolar sealing technology. J Arthroplasty 2007; 22:82-85. 7. Santiago, P. Controlling Epidural Bleeding and Improving Visibility During Spinal Surgery with a Novel Bipolar Sealing Technology: A Case Report. 2007, Medtronic White Paper. 8. Snyder BD, Hedequist DJ, Shannon EG. Hemostatic efficacy of bipolar wound sealer as adjunct to wound management in children with neuromuscular scoliosis (abstract).

Annual Meeting of the Pediatric Orthopaedic Society of North America, 2007.9. Small HN, Chisholm SD. Use of a New Bipolar Sealing Technology to Reduce Blood Loss During Instrumented Lumbar Fusion Surgery. 2009, Medtronic White Paper.10. Covance report; 2008 MedPAR database based on ICD-9-CM Codes for 100% of Medicare beneficiaries. 11. Performance has not been specifically established with the Aquamantys System.

References

© 2

011,

Med

tron

ic, I

nc. A

ll rig

hts

rese

rved

. Aqu

aman

tys®

and

Tra

nsco

llatio

n® a

re re

gist

ered

trad

emar

ks o

f Med

tron

ic, I

nc.

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

Mean LOS for spine surgery with and without a transfusion10

5.45

4.53

TABLE 1

Average costs of spine surgery with and without a transfusion10

With Transfusion Without Transfusion

$32k$29k

$40,000

$30,000

$20,000

$10,000

0


8

6

Day

s

4

2

0

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.1,2

• Reduces transfusion rates by minimizing intra- and post-operative blood loss1–4

• May reduce the need for other blood management products during and after surgery1,2

• Reducing allogenic blood transfusions may result in reduced post-operative complications5,6

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. E-published in 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. Performance has not been specifically established with the Aquamantys System.6. 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

© 2

011,

Med

tron

ic, I

nc. A

ll rig

hts

rese

rved

. Aqu

aman

tys®

and

Tra

nsco

llatio

n® a

re re

gist

ered

trad

emar

ks o

f Med

tron

ic, I

nc.




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.

• The Aquamantys Pump Generator remains an asset of Medtronic

• The Aquamantys Pump Generator is placed in the hospital under a no-charge placement agreement

• Medtronic performs all required servicing of the generator

• There are no:

- 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.

• Medtronic performs all required servicing of the generator• Medtronic performs all required servicing of the generator

- Minimum disposable purchase requirements for use- Minimum disposable purchase requirements for use

• Medtronic performs all required servicing of the generator• Medtronic performs all required servicing of the generator

- Minimum disposable purchase requirements for use- Minimum disposable purchase requirements for use

Transcollation technology provides broad tissue-surface hemostasis in a rapid and controlled manner with thepotential to save costs compared to traditional blood management methods.1

Aquamantys® System’sClinical Value

CLINICAL BENEFITS

- Successfully prevents and stops epidural bleeding near critical structures2

- Reduces transfusion rates by minimizing intra-operative blood loss1,3-5

- May help improve visibility in the surgical field2,5,6

- Reducing allogeneic blood transfusions may result in reduced post-operative complications7,8

- Decreases surgical time and blood loss per level fused5,6,9

- May reduce the need for other blood management products before and after the procedure1,3

- Reduces transfusion rates, which contributes to hospital cost savings1,3,4,7,10

ECONOMIC BENEFITS

Transcollation technology provides broad tissue-surface hemostasis in a rapid and controlled manner with theTranscollation technology provides broad tissue-surface hemostasis in a rapid and controlled manner with theTranscollation technology provides broad tissue-surface hemostasis in a rapid and controlled manner with theTranscollation technology provides broad tissue-surface hemostasis in a rapid and controlled manner with theTranscollation technology provides broad tissue-surface hemostasis in a rapid and controlled manner with theTranscollation technology provides broad tissue-surface hemostasis in a rapid and controlled manner with theTranscollation technology provides broad tissue-surface hemostasis in a rapid and controlled manner with the

PATIENT BENEFITS

- Helps to maintain hemoglobin levels4

- Reduces transfusion rates by minimizing intra-operative blood loss1,3-5

- Reduced transfusion rates contribute to reduced hospital length of stay11

References

© 2

011,

Med

tron

ic, I

nc. A

ll rig

hts

rese

rved

. Aqu

aman

tys®

and

Tra

nsco

llatio

n® a

re re

gist

ered

trad

emar

ks o

f Med

tron

ic, I

nc.




1. Marulanda GA, Ulrich SD, et al. Reductions in blood loss with a bipolar sealer in total hip arthroplasty. Expert Rev Med Devices 2008; 5:125-131.2. Santiago, P. Controlling Epidural Bleeding and Improving Visibility During Spinal Surgery with a Novel Bipolar Sealing Technology: A Case Report. 2007, Medtronic White Paper.3. Performance has not been specifically established in all procedures.4. Marulanda GA, Krebs VE, et al. Hemostasis using a bipolar sealer in primary unilateral total knee arthroplasty. E-published in the American Journal of Orthopedics, 2009;

38(12):E179-183.5. 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.0b013e3182334ec5.6. Snyder BD, Hedequist DJ, Shannon EG, Hemostatic efficacy of bipolar wound sealer as adjunct to wound management in children with neuromuscular scoliosis (abstract).

Annual Meeting of the Pediatric Orthopaedic Society of North America, 2007.7. Performance has not been specifically established with the Aquamantys® System.8. Bierbaum BE, et al. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am 1999; 81:2-10.9. Small HN, Chisholm SD. Use of a New Bipolar Sealing Technology to Reduce Blood Loss During Instrumented Lumbar Fusion Surgery. 2009, Medtronic White Paper. 10. Covance report; 2008 MedPAR database based on ICD-9-CM Codes for 100% of Medicare beneficiaries.11. Covance MedPAR report; length of stay has not been specifically correlated with the Aquamantys System.

TRANSCOLLATION® technology simultaneously delivers 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.

Aquamantys® System’sEconomic Value

Transcollation® technology is an important evolution in providing hemostasis for patient care. We recognize that healthcare providers (HCPs) have several options for managing patient hemoglobin levels perioperatively in conjunction with budget management. Medtronic is committed to delivering improved clinical outcomes while saving hospitals money.

We also recognize there are various methods currently employed to provide hemostasis during surgery. Tables 1 and 2 below represent hospital national-average costs for transfusions and length of stay (LOS) for spine surgery based on MedPAR data.1 Transcollation technology has been shown to provide clinical benefits by reducing blood transfusions and the use of other blood management products, thereby contributing to hospital cost savings.2,3

TABLE 1

Average costs of spine surgery with and without a transfusion1


$32k$29k

$40,000

$30,000

$20,000

$10,000

0

TABLE 2

Mean LOS for spine surgery with and without a transfusion1

5.45

4.53


8

6

Day

s

4

2

0

1. Covance report; 2008 MedPAR database based on ICD-9-CM Codes for 100% of Medicare beneficiaries.2. Performance has not been specifically established with the Aquamantys System.3. 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. 4. Bierbaum BE, et al. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am 1999; 81:2-10.5. 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.0b013e3182334ec5.6. Performance has not been specifically established in all procedures.

References

© 2

011,

Med

tron

ic, I

nc. A

ll rig

hts

rese

rved

. Aqu

aman

tys®

and

Tra

nsco

llatio

n® a

re re

gist

ered

trad

emar

ks o

f Med

tron

ic, I

nc.




Aquamantys® System’s Impact on Transfusion Rates and Blood LossTransfusions are known to increase the likelihood of post-surgical complications and frequently contribute to increased length of stay.1,2,4 Transcollation® technology has been clinically shown to reduce blood transfusion rates by minimizing intra-operative blood loss during spine surgery.5,6

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.3,6

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

Transfusion rate without Transcollation technology5

Transfusion rate withTranscollation® technology5,6

6%

0%

Select Spine Publications

Phase I Preliminary results indicate 22 patients have been enrolled with a mean loss of hemoglobin of 82 g ± 6 g (mean ± SE). Though the blinding has not been broken, the results suggest a trend towards decreased hemoglobin loss in patients treated with Tissuelink (70.95 g ± 6.8 g, n = 11) compared to patients treated with traditional electrocautery and sealants (93.9 g ± 8.9, n = 11, p = 0.054). For the study to be appropriately powered, at least 64 patients need to be randomized in order to detect 25% reduction in intraoperative blood loss (p = 0.05, power = 0.90).

Phase IPhase IPreliminary results indicate 22 patients have been enrolled with a mean Preliminary results indicate 22 patients have been enrolled with a mean loss of hemoglobin of 82 g ± 6 g (mean ± SE). Though the blinding loss of hemoglobin of 82 g ± 6 g (mean ± SE). Though the blinding has not been broken, the results suggest a trend towards decreased has not been broken, the results suggest a trend towards decreased hemoglobin loss in patients treated with Tissuelink (70.95 g ± 6.8 g, hemoglobin loss in patients treated with Tissuelink (70.95 g ± 6.8 g, n = 11) compared to patients treated with traditional electrocautery n = 11) compared to patients treated with traditional electrocautery and sealants (93.9 g ± 8.9, n = 11, p = 0.054). For the study to be and sealants (93.9 g ± 8.9, n = 11, p = 0.054). For the study to be appropriately powered, at least 64 patients need to be randomized in appropriately powered, at least 64 patients need to be randomized in order to detect 25% reduction in intraoperative blood loss (p = 0.05, order to detect 25% reduction in intraoperative blood loss (p = 0.05, power = 0.90). power = 0.90).

Prospective, Randomized, Double-Blinded Study of Tissuelink Versus Traditional Electrocautery and Sealants for Intraoperative Hemostasis During Spinal Surgery. Diesen DL, Sabesan V, Broomer B, Richardson WJ, White W, Hill SE. SABM Abstracts: Transfusion, Vol. 48, September 2008.

Hemostasis with a bipolar sealer during surgical correction of adolescent idiopathic scoliosis. Mankin KP, Moore CA, Miller LE, Block JE. E-published in Journal of Spinal Disorders & Techniques, October 2011. doi:10.1097/BSD.0b013e3182334ec5

During posterior spinal fusion surgery for deformity, this study showed a significant 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 significantly 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. Presented in part at the Annual Meeting of the Pediatric Orthopaedic Society of North America; Hollywood, Fl., May 23-26, 2007.

This 70 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.

© 2

011,

Med

tron

ic, I

nc. A

ll rig

hts

rese

rved

. Aqu

aman

tys®

and

Tra

nsco

llatio

n® a

re re

gist

ered

trad

emar

ks o

f Med

tron

ic, I

nc.




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

Barnes-Jewish Hospital at Washington UniversitySt. Louis, MO

Cleveland ClinicCleveland, OH

Duke University Medical CenterDurham, NC

Hospital for Special SurgeryNew York, NY

Johns Hopkins HospitalBaltimore, MD

Mayo ClinicRochester, MN

Medical University of South CarolinaCharleston, SC

Methodist Hospital Houston, TX

Mount Sinai Medical CenterNew York, NY

New York - Presbyterian UniversityHospital of Columbia and CornellNew York, NY

Northwestern Memorial HospitalChicago, IL

NYU Medical CenterNew York, NY

Ronald Reagan UCLA Medical Center Los Angeles, CA

Rush Presbyterian HospitalChicago, IL

Stanford Hospital and ClinicsPalo Alto, CA

University of California, San FranciscoMedical CenterSan Francisco, CA

University of Pennsylvania Health SystemPhiladelphia, PA

UPMC - University of Pittsburgh Medical CenterPittsburgh, PA

Vanderbilt University Medical CenterNashville, TN

Yale-New Haven HospitalNew Haven, CT

Top Hospitals UsingTranscollation® Technology

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

References

© 2

011,

Med

tron

ic, I

nc. A

ll rig

hts

rese

rved

. Aqu

aman

tys®

and

Tra

nsco

llatio

n® a

re re

gist

ered

trad

emar

ks o

f Med

tron

ic, I

nc.




14 of the top 17 hospitals in the Honor Roll of “America’s Best Hospitals,” US News & World Report, 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

Mount Sinai Medical Center, New York, NY

Stanford Hospital and Clinics, Stanford, CA

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



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.

© 2

011,

Med

tron

ic, I

nc. A

ll rig

hts

rese

rved

. Aqu

aman

tys®

logo

and

Tra

nsco

llatio

n® a

re re

gist

ered

trad

emar

ks o

f Med

tron

ic, I

nc.

71-1

0-22

97

1

0.11

Rev

A

aquamantys spine solutions - medeltip.com€™s advanced energy products deliver proprietary...

Documents