2016
When the HeartWare deal was announced in 2016, Medtronic projected the ventricular assist device market at about $800 million, with high-single-digit to low-double-digit growth after 2017. The product brought in $141 million of revenue during Medtronic’s fiscal year 2021.

HeartWare® Left Ventricular Assist Devices (HVAD)The HeartWare® Left Ventricular Assist System (LVAS) is a third-generation continuous flow blood pump for the treatment of advanced heart failure. It features a miniaturized centrifugal pump, which is small enough to be implanted above the diaphragm in all patients.

centrifugal
The HeartWare HVAD® is a type of “artificial heart” pump that is surgically implanted inside the chest and is connected directly to the heart to help provide mechanical support to a failing heart. Using centrifugal force, the pump continuously pulls blood from the left ventricle and sends it to the aorta.

Although ECMO provided for prompt resuscitation and resolution of organ injury and provided time to perform a transplant evaluation, the implantable LVAD provided a means for lower-risk, long-term circulatory support and rehabilitation.

Medtronic
Medtronic has acquired HeartWare International, Inc., developer of miniaturized left ventricular assist devices (LVADs) for the treatment of heart failure, for $1.1 billion. The deal provides a shot in the arm for the struggling HeartWare, and gives Medtronic a foothold in the promising LVAD market.

There are 2 types of FDA-approved LVADs: pulsatile and nonpulsatile, also known as continuous-flow LVADs. Pulsatile LVADs mimic the natural rhythmic action of the heart, while continuous-flow LVADs use a motor at fixed speeds, leading to constant ejection of blood to the systemic circulation.

After three strikes in just the last six months, Medtronic’s implantable heart pump is out. The company issued (PDF) an urgent message Thursday notifying doctors and patients that it would immediately stop selling and distributing the HeartWare Ventricular Assist Device, or HVAD.

Medtronic acquired the pump as part of its $1.1 billion acquisition of HeartWare International in 2016. The device helps patients suffering from heart failure pump blood through their bodies.

The ENDURANCE trial demonstrated noninferiority of the intrapericardial centrifugal-flow HeartWare HVAD compared to the axial-flow HeartMate II left ventricular assist device (LVAD) regarding survival in patients with advanced heart failure ineligible for heart transplantation, but stroke was more common.

Both Bridge to Transplant (BTT) therapy and Destination Therapy (DT) use the HeartMate 3. Doctors implant the HeartMate 3 by surgery through the sternum (or chest). This is called a sternotomy. Or doctors may use a , which is a less invasive .

Each left ventricular assist device (LVAD) helps your failing heart to pump blood to the rest of your body. (Blood carries oxygen, which we need to live.)

Data from 3 institutions revealed an abrupt increase in HeartMate II (Thoratec) pump thrombosis starting in 2011, associated with 48% mortality at 6 months without transplantation or pump exchange.