HeartMate III™ Left Ventricular Assist Device (LVAD)
HeartMate III™ is an advanced left ventricular assist device (LVAD) approved for use in advanced heart failure patients who require short or long-term mechanical cardiovascular support such as bridge to transplant (BTT) or destination therapy (DT).
Developed by Thoratec Corporation, the device received European CE Mark in October 2015. St Jude Medical acquired Thoratec in the same month. Abbott added the tool to its portfolio as a result of acquiring St Jude Medical in January 2017.
A pre-market approval (PMA) application for the device was submitted to the US Food and Drug Administration (FDA) for short-term cardiac support in advanced heart failure patients in December 2016, with approval by the FDA for clinical use following in August 2017.
It received additional approval for long-term cardiac support such as DT in patients in October 2018.
The FDA approved an alternative, less-invasive surgical method for implanting the HeartMate III heart pump in patients in January 2020.
HeartMate III LVAD is an implantable circulatory support system comprising an LVAD pump, system controller and battery unit.
LVAD pump implants in the thorax of the patients, covered with a titanium shell. The pump weighs 200gm, measuring 50.3mm in diameter and 55.8mm in height, including inflow cannula, connecting the pump to the patient’s circulatory system. It operates at speeds of 3,000rpm and 9,000rpm. The functioning voltage of the pump is 10V to 17V, while power consumption is 4W.
The pump is connected to an external wearable system controller via a driveline that crosses the patient’s abdominal region. The system controller serves as a power and communication centre, providing information regarding the status of the pump and allowing clinicians to control and adjust its parameters.
The power cable connectors join external power devices such as mobile power unit, power module or 14V Lithium-Ion batteries to the system controller.
The system uses Full MagLev™ flow technology for maintaining consistent blood flow, reducing stress. HeartMate III is the first commercially-approved Full MagLev flow technology-based centrifugal-flow LVAD.
The technology fully levitates the device’s self-centring rotor by the magnetic forces, avoiding the need for hydrodynamic or mechanical bearings.
The technology reduces stasis, thrombus and other haemocompatibility-related adverse events in patients.
In a healthy human, the left ventricle of heart adequately pumps the blood to the entire body. However, after surviving heart failure, the left ventricle gets weakened, failing to pump blood to the whole body.
HeartMate III heart pump operates parallel to the heart and assists the weakened left ventricle in pumping blood to the aorta, increasing the blood flow mechanically. The pump can produce a blood flow rate up to 10lit / min.
The FDA approved the device based on a clinical study named MOMENTUM 3, the most extensive LVAD study in the world to determine patients’ need for short as well as long-term cardiac support. The study initially enrolled 294 patients and compared patient survival between the groups, using the HeartMate III LVAD and HeartMate II™ LVAS.
Approximately 86% of the patients implanted with HeartMate III LVAD showed six months of survival without any stroke or need for pump replacement, compared to 77% of patients using HeartMate II LVAS.
Among a total of 366 patients enrolled in the long-term clinical study, 77.9% using HeartMate III LVAD showed event-free survival for two years without any stroke or need for pump replacement, compared to 56.4% of the patients using HeartMate II LVAS.
At two years, the survival rate of the patients using HeartMate III LVAD was 82.8%. The full result of the MOMENTUM 3 clinical study demonstrated high event-free survival, low adverse event rates, and improved quality of life in patients using the HeartMate III LVAD device.
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