Feature | February 28, 2012

FDA Approves Trial Using Jarvik 2000 Heart as a Destination Therapy

Device to Provide Long-term, Permanent Support for Heart Failure Patients Who are Not Eligible for Transplant

The Jarvik 2000 heart includes the blood pump inside the natural heart (white arrow), the internal cable (blue arrow), the behind-the-ear connector (green arrow) the belt worn controller (yellow arrow), the belt worn battery (grey arrow), and the external cables (black).

February 27, 2012 – Jarvik Heart Inc. announced conditional U.S. Food and Drug Administration (FDA) approval of its pivotal trial for evaluation of the Jarvik 2000 heart for destination therapy (DT). Use of the device for DT means that it will provide long-term, permanent support to end-stage congestive heart failure patients who are not candidates for heart transplant.

The approval permits 50 medical centers to participate in the study. Each medical center may begin enrolling patients immediately upon approval by their institutional review board.

The trial will randomize up to 350 study subjects to either the treatment group, in which patients receive the Jarvik 2000 intraventricular heart assist device, or the control group, in which patients receive the HeartMate II left ventricular assist device (LVAD), the most widely used FDA-approved LVAD for DT. Patients will be followed for two years to assess primary endpoint success, generally defined as survival free of disabling complications. If the data analysis at two years, or at a prior interim analysis, establishes non-inferiority of the Jarvik 2000 compared to the control, the trial will be judged successful.

Patients will be followed for another year and the rates of serious infection related to the power cable and pump pocket will be analyzed for the three years since implant. The analysis will determine if the Jarvik 2000, which uses a behind-the-ear power cable and has no pump pocket, is superior to the HeartMate II, which uses an abdominal cable and has an abdominal pump pocket.

The Jarvik 2000 has been used to treat late-stage heart failure in more than 500 patients in the United States, Europe and Asia. The Jarvik 2000 model with the behind-the-ear connector has supported more than 200 patients in Europe for DT, including the longest survival of any heart assist device patient in the world, for seven and a half years.

The bridge-to-transplant model of the Jarvik 2000 has a power cable that exits the abdominal wall — the same position used with the HeartMate II and HeartWare VADs. The behind-the-ear cable, which will be used in this study, may have significant quality-of-life advantages over abdominal cables. It requires practically no care of the cable exit site and, unlike abdominal cables, does not require frequent redressing with sterile bandages that may require expensive home nursing. Jarvik 2000 patients with the behind-the-ear connector may shower and bathe normally and can even go swimming. In Europe, these patients have had low rates of infection, and there have been no failures of the internal cables and no mechanical failures of the Jarvik 2000 blood pump or its bearings. Long-term bench durability tests project high reliability of the device for 10 years or more.

Prior to full FDA approval of the trial, the company must submit additional information concerning statistical analysis and conduct of the study, as well as some additional engineering data.

Jarvik Heart has also completed enrollment of the primary cohort of 150 patients in the U.S. Bridge-to-Transplant Pivotal Study and is nearing completion of the follow-up period. Only two patients have yet to reach outcome.  The results in the study patients who received the most recent Jarvik 2000 model, using patented cone bearings, are expected to show a substantial improvement in the primary endpoint compared to the pin bearing design used earlier in the BTT study. Only cone bearings will be used in the DT trial.

Jarvik Heart is continuing research on new developments including child size and tiny infant size pumps with the support of the National Institutes of Health under the PumpKIN program (Pumps for Kids, Infants and Neonates).

For more information: www.jarvikheart.com

 

Related Content

Medtronic HeartWare HVAD System Approved for Destination Therapy
Technology | Ventricular Assist Devices (VAD) | October 04, 2017
October 4, 2017 — Medtronic received U.S.
Abiomed Receives FDA PMA Approval for Impella RP for Right Heart Failure
Technology | Ventricular Assist Devices (VAD) | September 28, 2017
Abiomed Inc. recently received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP ...
Abbott Receives FDA Approval for HeartMate 3 Left Ventricular Assist System
Technology | Ventricular Assist Devices (VAD) | August 29, 2017
Abbott announced it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left...
Pre-PCI Impella 2.5 Insertion Improves Survival in Left Main Coronary Artery Heart Attacks
News | Ventricular Assist Devices (VAD) | June 30, 2017
Abiomed Inc. announced the recent publication of a peer-reviewed retrospective study on hemodynamic support with the...
Heartware HVAD recall for its ventricular assist device from Medtronic
Feature | Ventricular Assist Devices (VAD) | May 05, 2017
May 5, 2017 — Medtronic Mechanical Circulatory Support is expanding its recall of its HeartWare Ventricular Assist De
Videos | Ventricular Assist Devices (VAD) | April 14, 2017
A discussion with William O'Neill, M.D., FACC, FSCAI, medical director of the Center for Structural Heart Disease at
Henry Ford Hospital, Detroit Cardiogenic Shock Initiative, Impella pump, ACC.17 clinical study
News | Ventricular Assist Devices (VAD) | April 03, 2017
Hospitals can dramatically increase heart attack survival rates in patients suffering cardiogenic shock by providing...
Metro Detroit cardiologists, increased heart attack survival rate, Impella heart pump, Detroit Cardiogenic Shock Initiative
News | Ventricular Assist Devices (VAD) | March 09, 2017
Metro Detroit cardiologists from five health systems have joined together to increase residents’ survival rate from...
Impella 2.5 heart pump, high-risk PCI, HRPCI, acute kidney injury risk, AKI, Circulation Research study, Abiomed
News | Ventricular Assist Devices (VAD) | March 09, 2017
A new study published in Circulation Research finds use of hemodynamic support with the Impella 2.5 heart pump during...
James Ward, LVAD surgery, left ventricular assist device, UAB, University of Alabama at Birmingham
News | Ventricular Assist Devices (VAD) | March 08, 2017
Congestive heart failure patients at the University of Alabama at Birmingham (UAB) now have reason for optimism with a...
Overlay Init