HEARTWARE HVAD SYSTEM

Advanced Heart Failure Management

  

Learn from VAD Therapy experts as they discuss new data, trends, and implanting techniques in Mechanical Circulatory Support.

The Only VAD approved for Less-Invasive Thoracotomy

The HeartWare™ HVAD™ Pump is the world's smallest, commercially available, full-support centrifugal VAD designed to be implanted completely within the pericardial space.1 The HeartWare HVAD System is the only full-support, durable VAD FDA-approved for a less invasive thoracotomy approach, as well as both destination therapy and bridge to transplant.

87% SURVIVAL AT TWO YEARS WITH THORACOTOMY

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.2

The primary endpoint was a composite of six-month survival free of disabling stroke (i.e. modified Rankin score ≥ 4 assessed 12 weeks post-event), while alive on the originally implanted device and free from disabling stroke, transplanted by month six or explanted due to left ventricular recovery by month six. Success is defined as non-inferiority of thoracotomy compared to sternotomy. Success was met if the lower bound of the one-sided exact 95% confidence limit was greater than 77.5%.

LATERAL demonstrated an 87% event-free survival rate at two years on device support.3

KAPLAN-MEIER SURVIVAL3

kaplan-meier chart displaying event-free 87% survival of HVAD patients enrolled in LATERAL study

30% REDUCED LENGTH OF STAY VIA THORACOTOMY

The pre-specified secondary endpoint in LATERAL was an improvement in the mean length of initial hospital stay as compared to a performance goal of median sternotomy subjects: 18 ± 12 days for thoracotomy compared to 26 days for median sternotomy.

LATERAL also showed a 30% reduction in length of stay for enrolled patients implanted via thoracotomy compared to HVAD's previous BTT CAP trial, which only used the traditional sternotomy approach.4 The 14 day median length of stay for thoracotomy patients in LATERAL was 6 days shorter than in the BTT CAP trial (20).

LENGTH OF INITIAL HOSPITAL STAY (DAYS)

chart displaying 30% reduction in length of stay for patients implanted via thoracotomy in LATERAL study as compared to patients implanted via sternotomy in BTT CAP

Learn from VAD Therapy experts as they discuss new data, trends, and implanting techniques in Mechanical Circulatory Support.

ADVANTAGE HVAD

Over 2,000 patients are enrolled in HeartWare HVAD trials.5

As many as 350 hospitals trust the HeartWare HVAD System. It's used in 47 countries and serves more than 17,000 patients worldwide.5

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.

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.6

Dual motor stators enhance efficiency and provide redundancy to rotate the impeller.6

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.6

The unique integrated inflow cannula design offers the flexibility to fit into smaller framed patients and treat more complex patients.7-12 It also allows for stable inflow position even with body habitus changes.13

Easy to Implant

  • The small size reduces the need for a pump pocket, which may lead to decreased bleeding and decreased blood product use14
  • The design allows for less invasive exchange and explant14
  • 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 sites14
HeartWare HVAD Heart Pump
1

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).

2

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.

3

Strüber presentation at ISHLT 2018, Nice, France.

4

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

5

Source data on file with Medtronic as of October 2018.

6

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

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

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.

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

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.

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

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.