HEARTWARE HVAD SYSTEM

Advanced Heart Failure Management

  

PROVEN. TRUSTED. COMMITTED.

Forty-five percent of all heart transplants are bridged to transplant with a ventricular assist device (VAD).1 The Medtronic commitment to advance the treatment of end-stage heart failure has never been stronger.

The HeartWare™ HVAD™ System is the most widely studied implanted centrifugal ventricular device.2-5

Over 2,000 patients are enrolled in HeartWare HVAD trials.

As many as 350 hospitals trust the HeartWare HVAD System. It's used in 47 countries and serves more than 15,000 patients worldwide.*

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.

THE HVAD ADVANTAGE

Medtronic is pleased to announce what no other company can — the HeartWare HVAD System is the only full-support, durable VAD FDA-approved for a less invasive thoracotomy approach.

The HeartWare HVAD Pump is the world's smallest, commercially available, full-support centrifugal VAD designed to be implanted completely within the pericardial space.6

The unique integrated inflow cannula design offers the flexibility to fit into smaller framed patients and treat more complex patients.7-13 It also allows for stable inflow position even with body habitus changes.14

HVAD LATERAL, the first trial to examine VAD implantation via thoracotomy, demonstrated that the HVAD System is safe and effective at 1-year follow-up, when implanted utilizing this technique. All primary and secondary endpoints were met.15

HeartWare HVAD System Now Approved for Both Sternotomy and Thoracotomy

UNIQUELY DESIGNED

The HeartWare™ 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.16

Dual motor stators enhance efficiency and provide redundancy to rotate the impeller.16

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.16

Easy to Implant

  • The small size reduces the need for a pump pocket, which may lead to decreased bleeding and decreased blood product use17
  • The design allows for less invasive exchange and explant17
  • A 10mm outflow graft to the artery reduces the anastomotic size by approximately 50% compared to other devices. This leads to flexibility of arterial landing sites17
HeartWare HVAD Heart Pump

*

Source data on file with Medtronic as of February 2018.


1

Lund, L, et al. For the International Society for Heart and Lung Transplantation, The Registry of the International Society for Heart and Lung Transplantation. Thirty-second Official Adult Heart Transplantation Report – 2015; Focus Theme: Early Graft Failure, J Heart Lung Transplant. 2015;34:1244-1254.

2

Rogers, J, et al. Intrapericardial left ventricular assist device for advanced heart failure. NEJM 2017;376:451-460.

3

Aaronson, KD, et al. Use of an intrapericardial, continuous-flow, centrifugal pump in patients awaiting heart transplantation. Circulation 2012;125(25): 3191–3200.

4

Strueber, M, et al. Multi-center evaluation of an intrapericardial left ventricular assist system. JACC 2011;57: 1375-1382.

5

Slaughter, M, et al. HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transpl 2013;32: 675–683.

6

HVAD System Instructions for Use. HeartWare Inc. Framingham, MA USA 01/17. HeartMate 3 Left Ventricular Assist System, Instructions for Use. Thoratec Corporation, Pleasanton, CA, USA (2/2015).

7

Abicht, T, et al. Complex HeartMate II infection treated with pump exchange to HeartWare HVAD, ASAIO J. 2013;59:188-192.

8

Gregoric, I, et al, Diaphragmatic implantation of the HeartWare Ventricular Assist Device. J Heart Lung Transpl. 2011;30: 467-70.

9

Takeda, K, et al. Diaphragmatic implantation of the HeartWare ventricular assist device. J Heart Lung Transpl. 2011;30: 467-70.

10

Garcia, S, et al. Successful replacement of a Heart Assist 5 ventricular assist device with a HeartWare without removal of the original sewing/attachment rings: how to do it. Interact Cardiovasc Thorac Surg. 2013;16(6):888-889.

11

Palmen, M, et al. Implantation of a left ventricular assist device in patients with a complex apical anatomy. Ann Thorac Surg 2012;94: 2122-2125.

12

Morshuis, M, et al. A modified technique for implantation of the HeartWareTM left ventricular assist device when using bivalirudin anticoagulation in patients with acute heparin-induced thrombocytopenia. Interactive CardioVascular and Thoracic Surgery (2013) 1-2 doi:10.1093/icvts/ivt187.

13

Huang, J, et al. HeartWare ventricular assist device placement with congenitally corrected transposition of the great arteries. J Thorac and Cardiovasc Surg. 2013;145(2)e23-25. Epub ahead of print 6 Dec 2012: doi:10.1016/j.jtcvs.2012.11.008.

14

Sorensen EN, et al, Computed tomography correlates of inflow cannula malposition in a continuous-flow ventricular-assist-device. J Heart Lung Transpl 2013;32 (6):654-657.

15

Source data from HVAD LATERAL Study on file with Medtronic as of March 2018.

16

LaRose, J, et al. Design concepts and principal of operation of the HeartWare Ventricular Assist System. 2010. ASAIO:285-9.

17

Sabashnikov, a, et al. Outcomes in patients receiving Heartmate II versus HVAD left ventricular device as a bridge to transplantation. Transplant Proc. 2014;46:1469-75.