Jarvik Heart
Jarvik Heart develops advanced ventricular assist devices, including the Jarvik 2000® and the Jarvik 2015 15mm VAD, designed to support patients with severe heart conditions.
Jarvik 2000® Ventricular Assist Device
The Jarvik 2000® Ventricular Assist Device is engineered to enhance the weakened heart's blood output and help restore normal blood flow throughout the body. The device has been successfully implanted in over 1000 patients globally. It features an external controller allowing manual adjustment of pump speed to accommodate various activity levels. The pump can be powered for 8-10 hours on a single rechargeable Lithium-ion battery pack, with the external equipment weighing less than three pounds. Available in both abdominal and post-auricular connector models, the device can be implanted without a heart-lung bypass machine and is designed to grant reliable heart support for a decade or longer.
Jarvik 2015 15mm Ventricular Assist Device
The Jarvik 2015 15mm Ventricular Assist Device is specifically designed for pediatric patients. Nearly the size of a AA battery, this device is the only completely implantable VAD for small children. It is currently undergoing clinical trials in the United States. The device aims to support young patients with critical heart conditions, providing a means to manage severe heart dysfunction effectively. The compactness and specialized design underline its suitability for pediatric use, making it a significant development in pediatric cardiac care.
Regulatory Approvals and Certifications
The Jarvik 2000® Ventricular Assist Device has garnered various regulatory approvals and certifications worldwide. It has received CE Mark certification in Europe for both bridge-to-transplant and lifetime use. In Japan, it is approved by the PMDA for bridge-to-transplant usage. Within the United States, the device remains investigational but has been employed in over 200 patients suffering from heart failure. The device is also in clinical trials in the U.S. for lifetime use. These certifications emphasize the device's credibility and the broad regulatory recognition of its safety and efficacy.
Design and Features of the Jarvik 2000®
The Jarvik 2000® is designed to minimize patient reliance on mechanical support while enhancing the heart's recovery after surgery. Its small size allows it to fit inside the left ventricle, contrasting with larger VADs that require a pump pocket. The valveless design includes a bullet-shaped titanium shell, two ceramic bearings, and a rotor. The manual control system is user-friendly, enabling patients to adjust the pump speed and avoid unsafe extremes. The device can be implanted without a heart-lung bypass machine, and clinical experiences confirm its ease of implantation and sustained performance over time.
Bridge-to-Transplant and Lifetime Use
The Jarvik 2000® serves dual functions as a bridge-to-transplant and for lifetime support. It helps critically ill patients awaiting heart transplants maintain adequate heart function. Additionally, it has the potential to provide a bridge to recovery for rare but severe heart failure conditions. In Europe, the device is CE Mark approved for lifetime use, offering long-term support to patients with heart conditions. The design focuses on sustaining reliable heart function for extended periods, thereby reducing the need for additional mechanical interventions.