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Aquamantys™ Bipolar Sealers

Applications in Orthopaedics, Spine, Oncology, Neurosurgery, Thoracic, and Cardiac Implantable Electronic Devices

Overview

Aquamantys™ bipolar sealers use proprietary Transcollation™ technology, combining radiofrequency (RF) energy and saline to provide hemostatic sealing of soft tissue and bone without the smoke or char found in other methods. The combination of RF energy and saline allows the device to operate at approximately 100˚C — nearly 200˚C less than traditional electrosurgical devices.1 By controlling bleeding, Aquamantys™ bipolar sealers has been shown to significantly reduce the incidence of hematoma and reduce surgical time in a variety of procedures, and may reduce the need for hemostatic agents.1-5

Request more information or schedule a demo today, by calling 866-777-9400.

INDICATIONS

Aquamantys™ bipolar sealers are sterile, bipolar electrosurgical devices intended to be used in conjunction with the AEX™ generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site.

PRODUCT DETAILS

ACHIEVING HEMOSTATIS

These illustrations show how Aquamantys™ bipolar sealers achieve hemostasis with heat-induced collagen shrinkage in blood vessel walls.

Transcollation Illustration

Transcollation™

  1. RF energy and saline are applied to tissue.
  2. Heat-induced collagen shrinkage occurs.
  3. Vessels ˂1 mm may be occluded.

OBSERVED BENEFITS

Intra-operative

  • Significantly reduced total blood loss compared to traditional electrosurgery2
  • Improved visualization of the surgical site6
  • Reduced operating room time during infected total hip arthroplasty (THA) revisions. (157 vs 134 min, p=0.039)5
  • Reduced surgical time in spine surgery7
  • May reduce exposure to surgical smoke for surgeons and operating room staff8
  • May reduce the need for other hemostatic agents1

Patient

  • Reduced length of stay in primary THA by 12% (2.86 vs. 3.26 days, p < 0.0001)3
  • Increased number of patients discharged to home self-care following primary THA (33.6% vs. 24.1%, p < 0.0001)3
  • Less reduction in hemoglobin levels compared to traditional electrosurgery (3.4±1.3 vs. 3.0±1.2 g/dL, p=0.041)2
  • Reduced post-operative pain and swelling leading to reduced incidence of hemarthrosis9
  • 75% reduction in hematomas in THA (0.2% vs. 0.8%, p = 0.0024)3
  • Reduced blood transfusions compared to traditional electrosurgery (73%; 52% vs. 20%; p = 0.005)2
  • Reduced allogeneic blood transfusions may result in reduced post-operative infections and complications10
  • Reduced transfusion rates3 may contribute to reduced length of hospital stay

Economic

  • $740 savings per case on blood product costs due to lower transfusion rates11
  • More patients discharged to home or self-care vs. skilled nursing facilities or home health after hip arthroplasty — associated with a savings of $978–$4,486 to the healthcare system12
  • Reduced transfusion rates,3,4 which may lower costs to the hospital

Surgical applications of bleeding control

Orthopaedic

  • Total knee arthroplasty
  • Total hip arthroplasty
  • Total shoulder arthroplasty
  • Orthopaedic trauma procedures

Spine

  • Multilevel spinal fusion
  • Posterior cervical discectomy and fusion
  • Posterior lumbar interbody fusion (PLIF)
  • Anterior lumbar interbody fusion (ALIF)
  • Minimally invasive TLIF
  • Laminotomy, discectomy, and decompression

Surgical oncology

  • Hepatic resection
  • Distal pancreatectomy
  • Partial nephrectomy

Cardiac implantable electronic device procedures

  • Primary implants
  • Generator replacements/upgrades/
    capsulectomies

Neuro
(Indications for 2.3, EVS, Mini EVS, SBS, MIS FLEX, and MIS FLEX Mini)

  • Open craniotomy
  • Transsphenoidal procedures

Thoracic

  • Lung resection
  • Extrapleural pneumonectomy
  • Chest wall resection
  • Decortication
  • Mediastinal lymphadenectomy
  • Esophagectomy

Model Features

AEX Generator

AEX™ Generator

Powers all Aquamantys™ and PlasmaBlade™ devices and provides simultaneous activation of both technologies.

  • Touchscreen interface
  • Four memory settings
  • Lightweight
  • Rapid startup and priming
Aquamantys™ 6.0 Bipolar Sealer

Aquamantys™ 6.0 Bipolar Sealer

  • Delivers controlled thermal energy to tissue
  • Provides hemostatic sealing without the charring associated with standard electrosurgical devices
  • Dual electrode configuration enables painting motion to provide hemostatic sealing across broad planes of tissue
  • Bipolar technology alleviates need for grounding pad
Aquamantys 2.3 Bipolar Sealers

Aquamantys™ 2.3 Bipolar Sealers

  • Saline coupled electrodes allow hemostatic painting across broad planes of tissue to provide hemostatic sealing
  • 2.3 mm electrode width delivers more precise application of Transcollation technology
  • Bipolar technology alleviates need for grounding pad
Aquamantys MBS Bipolar Sealers

Aquamantys™ MBS Bipolar Sealers

  • Malleable shaft can be shaped to reach challenging areas
  • Built-in light for visualization of the surgical site
  • Large bipolar electrode configuration provides hemostatic sealing across broad planes of tissue
Aquamantys Endo VS 8.7R VATS Bipolar Sealer

Aquamantys™ Endo VS 8.7R VATS Bipolar Sealer

  • Thoracoscopic length enables minimally invasive procedures
  • Bipolar design alleviates the need for grounding pad
  • Provides hemostatic sealing while reducing char
  • Rounded electrodes allow broad plane hemostasis on chest wall
Aquamantys SBS 5.0 Sheathed Bipolar Sealer

Aquamantys™ 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)
  • Hemostatic sealing of soft tissue and bone (sheath open)
  • Flat-tipped electrodes allow compression of epidural veins
Aquamantys Epidural Vein Sealer (EVS)

Aquamantys™ Epidural Vein Sealer (EVS)

  • Insulated shaft enables electrode use near sensitive tissue such as dura and nerve roots
  • 4.0 mm tip accommodates small epidural access points
  • Flat bipolar electrodes allow compression of epidural veins
Aquamantys Mini Epidural Vein Sealer

Aquamantys™ Mini Epidural Vein Sealer

  • Insulated shaft enables simultaneous retraction and electrode use near sensitive tissue such as dura and nerve roots
  • 3.4mm tip size for small epidural access points
Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer

Aquamantys™ Endo DBS 8.7 Dissecting Bipolar Sealer

  • Laparoscopic length enables minimally invasive procedures
  • Bipolar electrodes alleviate need for grounding pad
  • Cone-shaped electrodes aid blunt dissection
  • Provides hemostatic sealing while reducing char    
Aquamantys 9.5 XL Bipolar Sealer

Aquamantys™ 9.5 XL Bipolar Sealer

  • Cone-shaped electrodes aid blunt dissection
  • Large bipolar electrode configuration allows hemostatic sealing across broad planes of tissue
  • Bipolar electrodes alleviate need for grounding pad    
      
Aquamantys MIS Flex And MIS Flex Mini

Aquamantys™ MIS FLEX AND MIS FLEX MINI bipolar sealers

  • Shaft is malleable throughout its entire length to achieve hemostasis in a variety of orientations
  • Adjustable bayonetted shaft and tip configuration enables access to critical structures in minimally invasive surgical procedures
  • Minimal profile of electrode housing for improved visibility
  • Rounded electrodes and additional saline ports minimize coagulum buildup on electrode tips
  • Electrode spacing allows for hemostasis of 1 mm diameter vessel
  • MIS FLEX has a shaft length of 7 in and MIS FLEX Mini has a shaft length of 4 in

Manuals and Technical Guides

Find these technical manuals in the Medtronic Manual Library, in the product labeling supplied with each device, or by calling Medtronic at 800-961-9055.

  • AEX™ Generator Operator's Manual
  • AEX™ Generator Preventative Maintenance Guide
  • Aquamantys™ 2.3 and 6.0 Bipolar Sealers Instructions for Use
  • Aquamantys™ 9.5XL Bipolar Sealer Instructions for Use
  • Aquamantys™ Epidural Vein Sealer (EVS) Instructions for Use
  • Aquamantys™ Mini Epidural Vein Sealer (EVS) Instructions for Use
  • Aquamantys™ SBS 5.0 Sheathed Bipolar Sealer Instructions for Use
  • Aquamantys™ Endo VS 8.7R VATS Bipolar Sealer Instructions for Use
  • Aquamantys™ Endo DBS 8.7 Dissecting Bipolar Sealer Instructions for Use
  • Aquamantys™ MIS FLEX and MIS FLEX Mini Bipolar Sealer Instructions for Use

Rx only. Refer to product instruction manual/package insert for instructions, warnings, precautions and contraindications.

1

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.

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

Ackerman SJ, Tapia CI, Baik R, Pivec R, Mont MA. Use of a bipolar sealer in total hip arthroplasty: medical resource use and costs using a hospital administrative database. Orthopedics 2014;37(5):e472-481.

4

Weeden SH, Schmidt RH, Isabell G. Hemostatic efficacy of a bipolar sealing device in minimally invasive total knee arthroplasty. J Bone Joint Surg Br Proceedings 2009; 91-B:45.

5

Clement RC, Kamath AF, Derman PB, et al. Bipolar sealing in revision total hip arthroplasty for infection: efficacy and cost analysis. J Arthroplasty 2012;27(7):1376-1381.

6

Procyk S. The Transcollation: Short Hospitals Stay and Accelerated Recovery in Total Hip and Knee Arthroplasties Using a Radiofrequency Bipolar Sealer - an Innovative Approach in the Conceptualization of the Surgical Gesture. Natl Acad of Surg 2015:15(2):87-97.

7

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.

8

Data on file. Report 81-10-5683.

9

Rosenberg AG. Reducing blood loss in total joint surgery with a saline-coupled bipolar sealing technology. J Arthroplasty 2007;22(4 Suppl 1):82-85.

10

Bierbaum BE, Callaghan JJ, Galante JO, Rubash HE, Tooms RE, Welch RB. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am. 1999;81(1):2-10.

11

Frank S, Dackiw E, Kebaish K. Radiofrequency bipolar hemostatic sealer reduces blood loss, transfusion requirements, and cost for patients undergoing multilevel spinal fusion surgery. J Orthop Surg Res. 2014 Jul 5;9:50-56. 

12

Nichols CI, Vose JG. Clinical Outcomes and Costs Within 90 Days of Primary or Revision Total Joint Arthroplasty. The Journal of Arthroplasty. 2016;31(7):1-7.