Device Brand List for User S Guide Reference

Manual of Operations Version 3.0

Appendix K: Device Brand List - Page 1 of 1

Device Brand List

1. Approved Durable Devices (potential for patient discharge): These devices should be enteredinto INTERMACS except in rare circumstances where a patient with an approved device is in the control arm of an FDA approval study.

CompanyDevicePosition

Abiomed, Inc. AbioCor TAHTAH

Berlin Heart, Inc.Berlin Heart EXCOR PediatricL/R

Micromed Technology, Inc. MicroMed DeBakey VAD – ChildL

SynCardia Systems, Inc. SynCardiaTAH

Thoratec Corporation HeartMate II LVASL

HeartMate IPL

HeartMate VEL

HeartMate XVEL

Thoratec IVADL/R

Thoratec PVADL/R

HeartWare, Inc. NovaCor PCL

NovaCor PCqL

HeartWare HVADL/R

2. Approved Temporary Devices: These devices should not be entered into INTERMACS (unless they are simultaneously implanted with a durable device orimplanted after a durable device). They do not meet the INTERMACS definition for “potential patient discharge”.

Company DevicePosition

Abiomed, Inc. Abiomed AB5000L/R

Abiomed BVS 5000L/R

CardiacAssist, Inc. Tandem HeartL/R

Thoratec Corp. Thoratec CentrimagL/R

Medtronic Biomedicus, Inc. BiomedicusR

Sorin GroupRevolutionL/R

3. Unapproved Durable Devices:(potential for patient discharge): These devices should not be entered into INTERMACS.

Company DevicePosition

Arrow International, Inc. Arrow LionheartL

CorAideL

Berlin Heart, Inc.Berlin Heart EXCOR AdultL/R

Berlin Heart INCORL/R

EVAHEART Medical USA, Inc.EvaheartL

Heartware, Inc.HeartwareL

Jarvik Heart, Inc.Jarvik 2000L

Medos Medizintechnik AGMedosL/R

L-VAD Technology, Inc.LVAD TechnologiesL

MicroMed Technology, Inc.MicroMed DeBakey VADL

Terumo Heart, Inc.Terumo DuraheartL

Toyobo, Co.ToyoboL

Ventracor, Inc.Ventracor VentrAssistL

4. Unapproved Temporary Devices: These devices should not be entered into INTERMACS.

CompanyDevicePosition

AbioMed, Inc.Impella RecoverL/R

Orqis Medical CorporationOrqis CancionL/R

Version 2.4 Version date 12/4/2013