Perfusion Solutions
 

Solutions

Medtronic is continually evaluating new technologies as well as potential business partnerships to extend more options to perfusionists, extracorporeal clinicians and blood management health care professionals.

Innovative Perfusion and Blood Management Solutions

The world of cardiovascular surgery is changing; there is more collaboration than ever as medical professionals around the world seek better patient outcomes. Medtronic is at the forefront of these discussions in partnership with thought leaders from the perfusion, surgery and anesthesiology communities to create solutions.

We are continually evaluating new technologies as well as potential business partnerships to extend more options to perfusionists, extracorporeal clinicians and blood management health care professionals. We are committed to continuing our tradition of pioneering new and unique solutions. Rely on Medtronic's solid track record of bringing you effective extracorporeal standards of care such as our Affinity® Oxygenation Systems, Carmeda® BioActive Surface, Bio-Pump® Plus centrifugal Blood Pump, Bio-Console® 560 Plus System, HMS Plus™ Hemostasis Management System and many more.

Rethinking Blood Conservation

The Medtronic RBC® Initiative is an evidence-based educational program that works with you to devise strategies and tactics to:

  • Reduce blood product usage
  • Help improve your patients' outcomes
  • Reduce the length of ICU and hospital stays
  • Minimize complications related to blood use

The RBC Initiative advocates a multi-modality approach to blood conservation to improve patient outcomes and reduce the financial burden of blood use-related complications. As a leader in blood management technologies, Medtronic is at the forefront of helping to implement effective blood conservation programs.

Blood is among the most vital patient-care resources used today, but it is not an endless resource. Over the past few decades, a number of factors have converged to turn blood use and blood conservation into matters that hospital administrators and medical professionals must urgently address. Cardiac surgery is particularly vulnerable. Transfusions for cardiac surgery use about 20% of the United States blood supply.1 Patients transfused during elective CABG surgery had twice the five-year mortality as those not transfused.2

For more information, contact your local Medtronic sales representative.

References

  1. Speiss BD. Transfusion and outcome in heart surgery. Ann Thorac Surg. 2002; 74(4):986-7.
  2. Engoren MC, Habib RH, Zacharias A, Schwann TA, Riordan CH, Durham SJ. Effect of blood transfusion on long-term survival after cardiac operation. Ann Thorac Surg. 2002; 74(4):1180-6.

Medtronic Resting Heart System

A New Way of Looking at Arrested Heart Surgery

Medtronic Perfusion Systems is dedicated to offering extracorporeal clinicians the benefits of devices that promote blood conservation. Our development of the Resting Heart® System is grounded in clinical results that demonstrate the benefits of lower hemodilution1-4, reduced complement activation5-6 and less blood contact with foreign surfaces when compared to a traditional circuit. Reduced hemodilution and blood activation lead to less postoperative transfusion. For clinicians and surgical teams concerned with blood conservation, mini circuits offer a compelling alternative. For certain patient populations refusing transfusion for reasons of faith or otherwise, the Resting Heart System has played an integral role. Learn more about how the St. Joseph Cardiac Surgery team used the Resting Heart System for a Jehovah's Witness patient:

A Clinical Case for the Resting Heart® System When Blood Transfusion is Not an Option (PDF, 2.2 MB)

rhs_setup_a-small

The Medtronic Resting Heart System is a low prime, reservoir-less, closed-to-air circuit designed to address the traditional challenges of cardiac surgery. It features active air removal technology, no blood-to-air interface, elimination of anti-foam agents and tip-to-tip Carmeda® BioActive Surface®*.

* Manufactured under license from Carmeda AB, Sweden. Carmeda is a registered trademark of Carmeda AB.

Important Safety Information

This product is coated with Carmeda® BioActive Surface under license from Carmeda AB and is licensed for use only as part of an extracorporeal blood circulation system or circuit which includes an oxygenator or blood pump.

Carmeda® is a registered trademark of Carmeda AB

Contraindication: The Medtronic Resting Heart Module is not intended for procedures in which high rates of pericardial or cardiotomy suction are necessary to manage acute disruptions in hemostasis. The addition of a venous reservoir system may be considered under those conditions.

The device is not indicated for patients with a body weight less than 10 kilograms.

The device is not designed, sold or intended for use except as indicated.

Indication: The Medtronic Resting Heart Module is indicated for use in surgical procedures requiring extracorporeal circulatory support, gas exchange, and thermal regulation. The device is indicated for use in procedures requiring blood flow rate of 1-6 lpm and lasting up to six hours. The system is indicated for use only with the Bio-Console.

The VARD is indicated for use only with the AAR1000. The Bio-Pump+ Blood Pump in the Medtronic Resting Heart Module is indicated for use only with the Bio-Console. The Carmeda Affinity NT Oxygenator and Carmeda Affinity Arterial Filter in the Medtronic Resting Heart Module have the same indications for use as a Carmeda Affinity NT Oxygenator and Carmeda Affinity Arterial Filter used in other extracorporeal circuits.

Warning: Because the Resting Heart Module is a closed-loop circuit considerations must be made in the methodology for sequestering and re-infusing left ventricular vent and pericardial suction blood. A cell salvaging and washing system may be utilized. Depending on the volume of blood being salvages, it may be necessary to incorporate a Carmeda-coated cardiotomy reservoir into the circuit.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions For Use which accompany each product.

References

  1. Balachandran S, Cross MH, Karthikeyan S, Mulpur A, Hansbro SD, Hobson P. Retrograde autologous priming of the cardiopulmonary bypass circuit reduces blood transfusion after coronary artery surgery. Ann Thorac Surg. 2002 Jun;73(6):1912-8.
  2. Eising GP, Pfauder M, Niemeyer M, Tassani P, Schad H, Bauernschmitt R, Lange R. Retrograde autologous priming: is it useful in elective on-pump coronary artery bypass surgery? Ann Thorac Surg. 2003 Jan;75(1):23-7.
  3. Rosengart TK, DeBois W, O'Hara M, Helm R, Gomez M, Lang SJ, Altorki N, Ko W, Hartman GS, Isom OW, Krieger KH. Retrograde autologous priming for cardiopulmonary bypass: a safe and effective means of decreasing hemodilution and transfusion requirements. J Thorac Cardiovasc Surg. 1998 Feb;115(2):426-38.
  4. Shapira OM, Aldea GS, Treanor PR, Chartrand RM, DeAndrade KM, Lazar HL, Shemin RJ. Reduction of allogeneic blood transfusions after open heart operations by lowering cardiopulmonary bypass prime volume. Ann Thorac Surg. 1998 Mar;65(3):724-30.
  5. Svenmarker, S, et al. Use of heparin-bonded circuits in cardiopulmonary bypass improves clinical outcome. Scand Cardiovasc J 2002;35:241-246.
  6. Heyer EJ, et al. Heparin-bonded cardiopulmonary bypass circuits reduce cognitive dysfunction. J Cardiothorac Vasc Anesth 2002;16(1):37-42.

Perfusion Solutions for Pediatric Patients

Medtronic is committed from the very start to providing more options for pediatric patients undergoing cardiopulmonary bypass:

Biocompatible Surface Solutions

Medtronic's biocompatible surface technologies mimic critical properties of the vascular endothelium to provide thromboresistance and biocompatibility. Featuring Carmeda® BioActive Surface*, recognized as the "Gold Standard" in biocompatible surfaces, and Trillium® Biosurface†, Medtronic has nearly two decades of expertise and worldwide leadership in biocompatible surfaces for cardiopulmonary bypass circuits.

Carmeda BioActive Surface

The Gold Standard in Biosurfaces for Extracorporeal Circuits

Carmeda BioActive Surface is a durable, non-leaching End Point Attached heparin biosurface that mimics heparan sulfate naturally found on the vascular endothelium lining the circulatory system to provide thromboresistance and biocompatibility. Carmeda BioActive Surface is an important component of many cardiovascular surgery teams' strategies to minimize the deleterious effects of cardiopulmonary bypass, providing these endothelial-like characteristics:

Heparin

  • Non-leaching heparin molecules are covalently bonded into the surface using an End Point Attached method.
  • The End Point Attached method assures that the heparin active binding sites are properly oriented to remain free to participate in biological reactions, similar to the orientation of heparan sulfate molecules naturally found on the vascular endothelium.
  • A high degree of bioactivity is consistently delivered due to the unique Carmeda BioActive Surface chemistry and its sophisticated manufacturing process.

Negative Charge

Heparin in Carmeda BioActive Surface is naturally negatively charged. The vascular endothelium is also negatively charged.

Hydrophilicity

  • Hydrophilic priming layer is strongly bonded to the artificial surface.

Carmeda Bioactive Surface Peer-Reviewed Published Clinical And Scientific Findings:**

  • Reduced risk of bleeding through maintenance of natural hemostatic mechanisms1
  • Reduced blood transfusion requirements2,3
  • Prevents coagulation cascade activation at Factor XIIa4
  • This is earlier in the coagulation cascade than the production of thrombin
  • Thrombin inactivation5,6
  • Maintains platelet function7,8
  • Reduced leukocytosis,9 granulocyte activation,10,11,12 granular release by neutrophils13,14
  • Reduced complement activation 5,11,15,16
  • Improved cost savings related to improved clinical outcomes.17

Note:Citations with bold font represent clinical studies. Citations with standard font represent experimental in vitro and in vivo studies.

* Manufactured under license from Carmeda AB, Sweden. Carmeda is a registered trademark of Carmeda AB.
** Select published articles

References
  1. Larm O, et al. A new non-thrombogenic surface prepared by selective covalent binding of heparin via a modified reducing terminal residue. Biomat Med Dev Art Org 1983;11:161-8.
  2. Svenmarker S, et al. Neurological and general outcome in low-risk coronary artery bypass patients using heparin coated circuits. Eur J Cardiothorac Surg 2001;19:47-53.
  3. Mahoney CB, et al. Transfusion after coronary artery bypass surgery: the impact of heparin bonded circuits. Eur J Cardiothorac Surg 1999;16:206-210.
  4. Elgue G, et al. Effect of surface-immobilized heparin on the activation of adsorbed Factor XII. Artif Organs 1993;17:721-726.
  5. Videm V, et al. In-vitro comparison of the heparin-coated and uncoated oxygenator circuits and 50% reduction of heparin dose. J Thorac Cardiovasc Surg 1991;101:654-6.
  6. Larm O, et al. An approach to anti-thrombosis by surface modification. Progress in Artificial Organs 1985. Cleveland: ISAIO Press 1986;313-8.
  7. Olsson P. Non-thrombogenic systems for extracorporeal gas exchange. Int J Artif Organs 1990;13:9.
  8. Larsson R, et al. The search for thromboresistance using immobilized heparin. Blood in contact with natural and artificial surfaces. Ann NY Acad Sci 1987;516:102-115.
  9. Belboul A, et al. Does heparin coating improve biocompatibility?: A study on complement, blood cells and postoperative morbidity during cardiac surgery. Perfusion 1997;12:385-391.
  10. Borowiec J, et al. Effects of heparin-coating of cardiopulmonary bypass circuits on leukocytes during simulated extracorporeal circulation. Cardiovasc Surg 1997;5:568-73.
  11. Kagisaki K, et al. Biocompatibility of heparin-coated circuits in pediatric cardiopulmonary bypass. Artif Organs 1997;21:836-40.
  12. Lundblad R, et al. Endothelin-1 and neutrophil activation during heparin-coated cardiopulmonary bypass. Ann Thorac Surg 1997;63:1361-7.
  13. Videm V, et al. Reduced granulocyte activation with heparin coated device in an invitro model of cardiopulmonary bypass. Artif Organs 1991;15:90-5.
  14. Borowiec J, et all. Heparin-coated circuits reduce activation of granulocytes during cardiopulmonary bypass - a clinical study. J Thor Cardiovasc Surg 1992;104:642-7.
  15. Fukutomi M, et al. Changes in platelet, granulocyte, and complement activation during cardiopulmonary bypass using heparin-coated equipment. Artif Organs 1996;20:767-76.
  16. Mollnew T, et al. Formation of C5a during cardiopulmonary bypass. Ann Thorac Surg 1991;52:92-7.
  17. Mahoney CB. Heparin-bonded circuits: clinical outcomes and costs. Perfusion 1998;13:192-204.

Trillium Biosurface

Triple Endothelial-like Action for Biocompatibility

Trillium Biosurface†  provides endothelial-like benefits for routine use during cardiopulmonary bypass procedures.

Heparin

Non-leaching heparin molecules are covalently bonded into the surface to provide anticoagulant and additional beneficial effects as heparan sulfate does in the natural endothelium.

Negative Charge

  • Sulphate and sulfonate groups are incorporated into the Trillium functional layer to mimic the negative charge of vascular endothelium.
  • Research demonstrates that negatively-charged sulphonated polymers:
    • Repel the negatively-charged platelets1-3
    • Inhibit thrombin by binding to antithrombin in a heparin-like manner4-6
    • May impair additional processes required for thrombus formation7-8
  • Heparin in Trillium Biosurface is naturally negatively charged.

Hydrophilicity

  • Polyethylene oxide (PEO) polymer is extremely hydrophilic along its entire chain, creating an "insulating" water layer structure between the blood and artificial surface to resist cell adhesion and protein deposition.
  • PEO-water interface has very low free energy and therefore a low driving force for protein adsorption or platelet adhesion.9,10
  • PEO chains are in continuous motion, due to their flexible molecular structure. The dynamic hydrated surface created by PEO chains is believed to repel proteins and platelets.11,12
  • Hydrophilic priming layer is strongly bonded to the artificial surface.

Trillium Biosurface Peer-Reviewed Published Clinical and Scientific Findings:*

  • Decreased likelihood to require blood products13
    • Platelet count preservation14-18
    • Affords the same protective effects on circulating platelet count drops as adding albumin to the prime15
  • Less platelet activation17
  • Less granulocyte activation17
  • Less complement activation after protamine administration16
  • Fewer circuit clots and no renal emboli18
  • Select published articles

† Technology licensed under agreement from BioInteractions, Limited, United Kingdom.

References
  1. Okkema AZ, et al. Physical and blood contacting characteristics of propyl sulphonate grafted biomer. Biomaterials 1991;12:3-12.
  2. Grasel TG, et al. Properties and biological interactions of polyurethane aniomers: effect of sulfonate incorporation. J Biomed Mater Res 1989;311-338.
  3. Lelah MD, et al. Polyether-urethane ionomers: surface property/ex vivo blood compatibility relationships. J Colloid Interface Sci 1985;104:422-439.
  4. Silver JH, et al. Anticoagulant effects of sulphonated polyurethanes. Biomaterials 1992;13:339-343.
  5. Charef S, et al. Heparin-like functionalized polymer surfaces: discrimination between catalytic and adsorption processes during the course of thrombin inhibition. Biomaterials 1996;17:903-912.
  6. Han DK, et al. Heparin-like anticoagulant activity of sulphonated poly(ethelene oxide) and sulphonated poly(ethylene oxide)-grafted polyurethane. Biomaterials 1995;16:467-471.
  7. Silver JH, et al. Anticoagulant effects of sulphonated polyurethanes. Biomaterials 1992;13:339-343.
  8. Santerre JP, et al. Effect of sulfonation of segmented polyurethanes on the transient adsorption of fibrinogen from plasma: possible correlation with anticoagulant behaviour. J Biomed Mater Res 1992;26:39-57.
  9. Lee JH, et al. Blood compatibility of polyethylene oxide surfaces. Prog Polym Sci 1995;20:1043-1079.
  10. Lee JH, et al. Platelet adhesion onto segmented polyurethane film surfaces modified by addition and crosslinking of PEO-containing block copolymers. Biomaterials 2000;21:683-691.
  11. Lee JH, et al. Blood compatibility of polyethylene oxide surfaces. Prog Polym Sci 1995;20:1043-1079.
  12. Lee JH, et al. Platelet adhesion onto segmented polyurethane film surfaces modified by addition and crosslinking of PEO-containing block copolymers. Biomaterials 2000;21:683-691.
  13. Dickinson T, et al. Trillium® -coated oxygenators in adult open-heart surgery: a prospective randomized trial. JECT 2002;34;248-253.
  14. Palanzo DA, et al. Effect of Carmeda¨ BioActive Surface coating versus Trillium® Biopassive Surface coating of the oxygenator on circulating platelet count drop during cardiopulmonary bypass. Perfusion 2001;16:279-283.
  15. Palanzo DA, et al. Effect of Trillium® Biopassive Surface coating of the oxygenator on platelet count drop during cardiopulmonary bypass. Perfusion 1999;14:473-479.
  16. Cazzaniga A, et al. Trillium® biopassive surface: a new Biocompatible treatment for extracorporeal circulation circuits. Int J Artif Organs 2000;23:319-24.
  17. Baksaas ST, et al. In vitro evaluation of new surface coatings for extracorporeal circulation. Perfusion 1999;14:11-19.
  18. Tevaearai HT, et al. Trillium coating of cardiopulmonary bypass circuits improves biocompatibility. Int J Artif Organs 1999;22:629-634.

Information, Safety, and Warnings

Carmeda BioActive Surface and Trillium Biosurface

Contraindication: This device used for any other purposes than for the indicated use is the responsibility of the user.

Warning: A strict anticoagulation protocol should be followed and anticoagulation should be routinely monitored during all procedures. The benefits of extracorporeal support must be weighed against the risk of systematic anticoagulation and must be assessed by the prescribing physician.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions For Use which accompany each product.

Custom Packs

Medtronic delivers customized perfusion circuits to your hospital or institution in a timely and cost effective manner. We are globally positioned to respond to the needs of our customers. Manufacturing and and fulfillment services are coordinated out of our strategically located, state-of-the-art Tijuana, Mexico and Kerkrade, The Netherlands facilities.

Our proprietary and flexible planning process ensures that we listen and respond to your needs. We offer several customer programs to meet your needs and the needs of the environment, by offering the finest quality components assembled to your exact specifications and packaged with consideration to setup efficiency and respect for the environment. Our world-renowned Gold Program offers one of the fastest delivery timeframes of product from specification design to utilization in the OR to meet the challenge of cardiopulmonary bypass.

Options:

*From cannula tip to cannula tip, Medtronic Custom Perfusion Systems can be designed with Carmeda® BioActive Surface or Trillium® BioSurface.

Last updated: 26 Feb 2013

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