Current technologies:

Practice and Status

The list

The following is a chart of the status of the implantable devices that are available around the world.  This list and the approval status was current as of May 2008.  Be sure to check the Library for links to each of these devices, the companies who manufacture them and other clinical, research and manuscript links.

Device Manufacturer/Location Type Approval status
Novacor World Heart Corporation/ Oakland, CA Pulsatile Approved for use in North America, European Union (EU) and Japan
Levacor World Heart Corporation/Oakland, CA Fully magnetically suspended centrifugal pump Completed feasibility trials in EU, ready for US trials starting 2008
PVAD Thoratec Corporation/ Pleasanton, CA Pulsatile pneumatically driven device Approved for bridge to transplant and post-cardiotomy recovery
IVAD Thoratec Corporation/ Pleasanton, CA Pulsatile pneumatically driven device FDA approved in US 2004 for advanced heart failure patients
CentriMag Blood Pump Thoratec Corporation/ Pleasanton, CA External centrifugal pump FDA approved for use up to 6 hours, trial underway to approve for use up to 30 days
Heartmate XVE Thoratec Corporation/ Pleasanton, CA Pulsatile electrically actuated pump  Approved for use in North America/EU- FDA approved for DT
Heartmate II Thoratec Corporation/ Pleasanton, CA Rotor driven continuous axial flow with ball and cup bearings Approved for use in EU and FDA approved for bridge to transplant in USA in April 2008; DT trial patient enrollment complete.  DT trial patient follow up in progress.
Incor Berlin Heart/Wiesenweg, Germany Continuous flow by magnetically suspended axial flow rotor Approved for use in EU but currently has USA/Canadian representation to work with FDA and on emergent use cases
Excor Berlin Heart/Wiesenweg, Germany Biventricular Paracorporeal pulsative VAD Approved for use in EU
Excor Pediatric Berlin Heart/Wiesenweg, Germany Biventricular Paracorporeal pulsative VAD Approved for use in EU
Impella LP 2.5 Abiomed/Danvers, MA Percutaneous left ventricular impeller  pump FDA investigational device

EU CE approval

Impella LP 5.0 Abiomed/Danvers, MA Peripherally implanted left ventricular impeller pump FDA investigational device

EU CE approval

Impella LD Abiomed/Danvers, MA Surgically placed left ventricular impeller pump FDA investigational device

EU CE approval

Impella RD Abiomed/Danvers, MA Fully implantable right ventricular assist device FDA investigational device

EU CE approval

AB 5000 Abiomed/Danvers, MA Vacuum assisted pump Approved for uni or bi ventricular short term support
BVS 5000 Abiomed/Danvers, MA External ventricular support First device approved for all patients with reversible heart failure
AbioCor (AbioCor II in development) Abiomed/Danvers, MA Total battery-powered replacement heart 2006 FDA approval for commercial use under Humanitarian Device Exemption
Jarvik 2000 FlowMaker Jarvik Heart, Inc./New York, NY Continuous flow, axial rotor supported by ceramic bearings Approved in EU for bridge to transplant and life-time use and is currently in clinical trials in the USA to obtain FDA approval
 DeBakey VAD/DeBakey VAD Child MicroMed Cardiovascular, Inc/Houston, TX Continuous flow, axial rotor supported by ceramic bearings Approved in EU.  Child version is FDA approved for children in USA under the Humanitarian Device exemption.  Adult version is under clinical trials in USA.
VentrAssist Ventracor Corporation/ Australia Continuous flow, hydrodynamically suspended centrifugal rotor Approved in EU and Australia.  In clinical trials in USA
MTIHeartLVAD MiTiHeart Corporation/ Gaithersburg, MD Continuous flow, magnetically suspended rotor In pre-clinical animal trials
C-Pulse Sunshine Heart Inc,/NSW, Australia Pulsatilve, inflatable cuff around aorta Clinical trials in Australia and New Zealand in 2004-5; 2007 filed an FDA Investigational Device Exemption (IDE) to begin clinical feasibility trials
HVAD HeartWare/Sydney, Australia and Miramar, FL Continuous flow, Magnetic impeller In clinical trial in Australia and EU.  FDA IDE given in May 2008 and clinical trials set to begin.  Texas Heart Institute likely to be the first center once IRB is obtained.
MVAD HeartWare/Sydney, Australia and Miramar, FL Continuous flow, Magnetic impeller Pre-clinical trials in Australia and EU
DuraHeart Terumo Heart Inc. Magnetically suspended centrifugal pump 3/3/08 got conditional FDA approval to begin enrollment in clinical trials for bridge to transplant indication

 

Now that you have gotten an overview of the devices that are internationally available or in trials, let's continue by taking a closer look at each one.

 

Optional:          If you desire to open the quiz and complete it as you go along, click the DETOUR sign.  Your name is required before beginning the exercise.  Or, you can wait until you are through.  Your choice...

NEXT

 

 

 

Home          Introduction          Current Technologies          Novacor          Thoratec          Abiomed          Jarvik

Micromed         MiTiHeart         Ventracor        Sunshine Heart         HeartWare        Berlin Heart         Terumo Heart         Wrap-up      

Library

This website is not intended to dictate practice.  Rather, it is offered as an educational resource.  Neither the course authors nor perfusioneducationonline.com take responsibility for application of the content to clinical practice.  The clinician is expected to carefully consider all relevant literature and training to make informed clinical decisions.

Copyright 2008