Alert Indications, Safety, and Warnings

HeartWare™ HVAD™ System Advanced Heart Failure Management

The HeartWare™ HVAD™ System is a full-support, durable ventricular assist device (VAD) that is FDA-approved for a less-invasive thoracotomy approach, destination therapy, and bridge to transplant.

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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 information

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

therapy advancements

IMAGINE WHAT'S NEXT

We continually learn and innovate, further advancing the treatment of end-stage heart failure. We are always striving to improve patient outcomes and the clinical experience of your practice.11

18,000+ Patient implants worldwide

350 hospitals 56 countries trust the  hvad system

2,000+ Patients enrolled in clinical trials

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.

SEE EDUCATION OFFERINGS

THORACOTOMY CLINICAL EVIDENCE

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

LEARN MORE

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

VIEW PUBLICATION

ECONOMIC IMPACT

Cost of Thoracotomy Approach: An Analysis of the LATERAL Trial

READ ABSTRACT

CLINICIAN  RESOURCES

contact information

24-HOUR CLINICAL SUPPORT

United States
888-494-6365

Germany, Austria, and Switzerland
+49 (0) 2159 8149 9008

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

Source data on file with Medtronic as of July 2019.