Alert Indications, Safety, and Warnings

Medtronic HVAD™ System Advanced Heart Failure Management

The Medtronic HVAD™ System is a full-support, durable left ventricular assist device (VAD) that received the CE mark for a less-invasive thoracotomy approach, destination therapy, and bridge to transplant.

ABOUT HVAD THERAPY
HVAD device product shot
Alert Indications, Safety, and Warnings

Overview

DISCOVER WHY HVAD

The HVAD™ Pump is the world’s smallest commercially available, full-support, centrifugal VAD, enabling unmatched procedural versatility.1

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product design

Uniquely Designed

The HVAD Pump is engineered for reliability and durability.

The pump's passive maglev with hydrodynamic bearings means there's no need for electronic sensors or mechanical bearings. This results in a less complex system that eliminates friction, heat, and component wear.2

Dual motor stators enhance efficiency and provide redundancy to rotate the impeller.2

A patented, wide-blade impeller features three blood flow paths. These are designed to enhance blood flow and reduce blood trauma while reducing the time blood travels through the device.2

The unique, integrated inflow cannula design offers the flexibility to fit into smaller-framed patients and treat more complex patients.3-8 It also allows for stable inflow position, even with body habitus changes.9

Easy to Implant

  • The small size reduces the need for a pump pocket, which may lead to decreased bleeding and decreased blood product use.10
  • The design allows for less-invasive exchange and explant.10
  • A 10 mm outflow graft to the artery reduces the anastomotic size by approximately 50% compared to other devices. This leads to flexibility of arterial landing sites.10
Image of full heart with HVAD pump inserted
Medtronic HVAD Pump on light blue background

Device Features  

30% smaller than other devices11
20% lighter than other devices11
38% less displaced volume11

Medtronic patient Al, living with the HVAD system since 2018

Al

Living with the
HVAD System
since 2018

SMART TECHNOLOGY

Unique to the HVAD System is smart technology that enables clinicians to access and download data to gain insights into the pump’s performance. Autologs™ 1.3, the latest update to our advanced device management service, provides clinicians with faster access to important pump data, and deeper insights into the chronology of events.

Learn More about Autologs 1.3

LEARN ABOUT THE LATEST HVAD™ ENHANCEMENTS.

HVAD with waveforms and driveline

DISCOVER

WHAT'S NEW.

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SURGICAL VERSATILITY

Less-invasive  Thoracotomy Approach

The HVAD™ System was the first LVAD approved for the less-invasive thoracotomy approach12 and it is also the only full-support, durable VAD with clinical evidence to prove its safety and effectiveness when used in a thoracotomy approach. HVAD implantation via the less-invasive thoracotomy approach has resulted in improved quality of life, reduced adverse events, and an unprecedented survival rate.13, 14

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CLINICAL EVIDENCE

Revolve Data

The Registry to Evaluate the HeartWare Left Ventricular Assist System (ReVOLVE) was a multicenter registry that collected post-CE-mark clinical data on patients implanted with the HVAD System as a bridge to transplant (BTT). It demonstrated extended survival on the HVAD System:

  • 89% freedom from disabling stroke at six years15
  • 82% freedom from any stroke at six years15
  • 51% survival at seven years15

Thoracotomy Data

A recent analysis found that HVAD implantation via the less-invasive thoracotomy approach resulted in:

  • A 30% relative reduction in length of stay compared to sternotomy approach13
  • An absolute average reduction in cost of more than $50,000 compared to sternotomy approach16

The latest clinical evidence from the HVAD LATERAL Trial demonstrated a significant improvement in quality of life: 

  • 95% freedom from debilitating stroke14
  • 30% reduced length of stay13
  • 87% unprecedented survival at 2 years13
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ADDITIONAL RESOURCES

EDUCATION AND TRAINING RESOURCES

Interested in learning more about the HVAD System and the less-invasive thoracotomy approach? Medtronic offers educational programs designed for clinicians interested in expanding their knowledge of VAD therapy and the HVAD System. To learn more about these educational opportunities, please speak with your Medtronic sales representative or register to access Medtronic Academy. Once you are registered, login and search for MCS.

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THORACOTOMY CLINICAL EVIDENCE

The first VAD approved for the less-invasive thoracotomy approach.12

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Read the latest Data: Long-term survival

The ReVOLVE Study: An Analysis of Advanced Heart Failure Patients Receiving an LVAD as a Bridge to Transplantation

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HVAD product image on a grey background

HVAD Enhanced

Discover new enhancements to the HVAD System.

Discover HVAD

CLINICIAN  RESOURCES

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24-HOUR CLINICAL SUPPORT

Germany, Austria and Switzerland

+49 (0) 2159 8149 9008

REQUEST MORE INFORMATION

CONTACT US

References

1

HVAD System Instructions for Use. HeartWare Inc. Framingham, MA USA 07/18. HeartMate 3 Left Ventricular Assist System, Instructions for Use. Thoratec Corporation, Pleasanton, CA, USA (02/17).

2

Larose JA, Tamez D, Ashenuga M, Reyes C. Design concepts and principle of operation of the HeartWare ventricular assist system. ASAIO J. July-August 2010;56(4):285-289.

3

Abicht T, Gordon R, Meehan K, Stosor V, McCarthy P, McGee E Jr. Complex HeartMate II infection treated with pump exchange to HeartWare HVAD. ASAIO J. March-April 2013;59(2):188-192.

4

Gregoric ID, Cohn WE, Frazier OH. Diaphragmatic Implantation of the HeartWare Ventricular Assist Device. J Heart Lung Transplant. April 2011;30(4):467-470.

5

Takeda K, Ahmad U, Malaisrie SC, Lee R, McCarthy PM, McGee EC Jr. Successful implantation of HeartWare HVAD left ventricular assist device with concomitant ascending and sinus of valsalva aneurysms repair. J Artif Organs. June 2012;15(2):204-206.

6

Morshuis M, Boergermann J, Gummert J, Koster A. A modified technique for implantation of the HeartWare™ left ventricular assist device when using bivalirudin anticoagulation in patients with acute heparin-induced thrombocytopenia. Interact Cardiovasc Thorac Surg. August 2013;17(2):225-226.

7

Palmen M, Verwey HF, Haeck ML, Holman ER, Schalij MJ, Klautz RJ. Implantation of a left ventricular assist device in patients with a complex apical anatomy. Ann Thorac Surg. December 2012;94(6):2122-2125.

8

Sorensen EN, Hiivala NJ, Jeudy J, Rajagopal K, Griffith BP. Computed tomography correlates of inflow cannula malposition in a continuous-flow ventricular-assist-device. J Heart Lung Transplant. June 2013;32(6):654-657.

9

Huang J, Slaughter MS. HeartWare ventricular assist device placement with congenitally corrected transposition of the great arteries. J Thorac Cardiovasc Surg. February 2013;145(2):e23-25.

10

Sabashnikov A, Mohite PN, Zych B, et al. Outcomes in patients receiving Heartmate II versus HVAD left ventricular device as a bridge to transplantation. Transplant Proc. June 2014;46(5):1469-1475.

11

Data extrapolated based on source data from: HVAD System Instructions for Use. HeartWare Inc., Miami Lakes, MA, USA. July 2018. Left Ventricular Assist System, Instructions for Use. Thoratec Corporation, Pleasanton, CA, USA. October 2017.

12

HVAD thoracotomy approval comparison with competitor. October 2020. Medtronic data on file.

13

McGee E Jr, Danter M, Strueber M, et al. Evaluation of a lateral thoracotomy implant approach for a centrifugal-flow left ventricular assist device: The LATERAL clinical trial. J Heart Lung Transplant. April 2019;38(4):344-351.

14

Wieselthaler G, et al. Temporal Adverse Event Profile following LVAD Implantation via a Thoracotomy Approach: 2 Year Follow-up of the LATERAL Trial. Presented at ASAIO 2019; San Francisco, CA.

15

Zimpfer D, Fiane AE, Larbalestier R, et al. Long-Term Survival of Patients With Advanced Heart Failure Receiving an Left Ventricular Assist Device Intended as a Bridge to Transplantation: The Registry to Evaluate the HeartWare Left Ventricular Assist System. Circ Heart Fail. March 2020;13(3):e006252.

16

Mokadam NA, McGee E, Wieselthaler G, et al. Cost of Thoracotomy Approach: An Analysis of the LATERAL Trial. Ann Thorac Surg. November 2020;110(5):1512-1519.