VAD’s & Device Availability List
A ventricular assist device (VAD) is a mechanical circulatory device that is used to partially or completely replace the function of a failing heart. Some VADs are intended for short term use, typically for patients recovering from heart attacks or heart surgery, while others are intended for long-term use (months to years and in some cases for life), typically for patients suffering from advanced congestive heart failure.
VADs are distinct from artificial hearts, which are designed to completely take over cardiac function and generally require the removal of the patient’s heart. VADs are designed to assist either the right (RVAD) or left (LVAD) ventricle, or both at once (BiVAD). The type that is used depends primarily on the underlying heart disease and the pulmonary arterial resistance that determines the load on the right ventricle.
LVADs are most commonly used, but when pulmonary arterial resistance is high, right ventricular assistance may become necessary. Long term VADs are normally used to keep patients alive with a good quality of life while they wait for a heart transplantation (known as a “bridge to transplantation”). However, LVADs are sometimes used as destination therapy, meaning they will never undergo heart transplant, and sometimes as a bridge to recovery.[1][2]
In the last few years, VADs have improved significantly in terms of providing survival and quality of life among recipients.[3]
This is a partial list and may never be complete
Referenced additions are welcome
| Device | Manufacturer | Type | Approval Status as of July 2010 |
|---|---|---|---|
| Novacor | World Heart | Pulsatile. | Was approved for use in North America, European Union and Japan. Now defunct and no longer supported by the manufacturer. (Heartware completed acquisition August 2012) |
| HeartMate XVE | Thoratec | Pulsatile | FDA approval for BTT in 2001 and DT in 2003. CE Mark Authorized. Rarely used anymore due to reliability concerns. |
| HeartMate II | Thoratec | Rotor driven continuous axial flow, ball and cup bearings. | Approved for use in North America and EU. CE Mark Authorized. FDA approval for BTT in April 2008. Recently approved by FDA in the US for Destination Therapy (as at January 2010). |
| HeartMate III | Thoratec | Continuous flow driven by a magnetically suspended axial flow rotor. | Widespread use |
| Incor | Berlin Heart | Continuous flow driven by a magnetically suspended axial flow rotor. | Approved for use in European Union. Used on humanitarian approvals on case by case basis in the US. Entered clinical trials in the US in 2009. |
| Excor Pediatric | Berlin Heart | External membrane pump device designed for children. | Approved for use in European Union. FDA granted Humanitarian Device Exemption for US in December 2011. |
| Jarvik 2000 | Jarvik Heart | Continuous flow, axial rotor supported by ceramic bearings. | Currently used in the United States as a bridge to heart transplant under an FDA-approved clinical investigation. In Europe, the Jarvik 2000 has earned CE Mark certification for both bridge-to-transplant and lifetime use. Child version currently being developed. |
| MicroMed DeBakey VAD | MicroMed | Continuous flow driven by axial rotor supported by ceramic bearings. | Approved for use in the European Union. The child version is approved by the FDA for use in children in USA. Undergoing clinical trials in USA for FDA approval. |
| VentrAssist | Ventracor[41] | Continuous flow driven by a hydrodynamically suspended centrifugal rotor. | Approved for use in European Union and Australia. Company declared bankrupt while clinical trials for FDA approval were underway in 2009. Company now dissolved and intellectual property sold to Thoratec. |
| MTIHeartLVAD | MiTiHeart Corporation | Continuous flow driven by a magnetically suspended centrifugal rotor. | Yet to start clinical trials. |
| C-Pulse | Sunshine Heart | Pulsatile, driven by an inflatable cuff around the aorta. | Currently in clinical trials in the US and Australia. |
| HVAD | HeartWare | Miniature “third generation” device with centrifugal blood path and hydromagnetically suspended rotor that may be placed in the pericardial space. | Obtained CE Mark for distribution in Europe, January 2009. Initiated US BTT trial in October 2008 (completed February 2010) and US DT trial in August 2010 (enrolment completed May 2012). |
| MVAD | HeartWare | HeartWare’s MVAD Pump is a development-stage miniature ventricular assist device, approximately one-third the size of HeartWare’s HVAD pump. | HeartWare Completed GLP Studies (September 2011). |
| DuraHeart | Terumo | Magnetically levitated centrifugal pump. | CE approved, US FDA trials underway as at January 2010. |
| Thoratec PVAD (Paracorporeal Ventricular Assist Device) | Thoratec | Pulsatile system includes three major components: Blood pump, cannulae and pneumatic driver (dual drive console or portable VAD driver). | CE Mark Authorized. Received FDA approval for BTT in 1995 and for post-cardiotomy recovery (open heart surgery) in 1998. |
| IVAD – Implantable Ventricular Assist Device | Thoratec | Pulsatile system includes three major components: Blood pump, cannulae and pneumatic driver (dual drive console or portable VAD driver). | CE Mark Authorized. Received FDA approval for BTT in 2004. Authorized only for internal implant, not for paracorporeal implant due to reliability issues. |
