Medtronic is developing a fully-implantable left ventricular assist device. The Dublin-based company announced Tuesday it had received breakthrough device designation for the technology.
Current LVAD systems, including the HVAD Medtronic inherited when it acquired HeartWare International for $1.1 billion in 2016, are connected to a driveline cable that extends outside the body to a controller. This is then connected to power sources (AC or DC adapter, batteries).
Medtronic’s new LVAD is being designed to be fully implanted inside the body. News of the development of the new LVAD system comes a little more than a year after Medtronic won approval for a less-invasive implant approach of its HVAD system.
FDA’s nod would allow for the HVAD to be implanted through thoracotomy, a small lateral, surgical incision between the patient's ribs on the left side of the chest. Approval for the implantation was fueled by data from the LATERAL prospective clinical trial, in which 144 patients, with end-stage heart failure who were eligible for a heart transplant, were enrolled at 26 centers in the U.S. and Canada.
The technology isn’t available anywhere.
It hasn’t been smooth sailing for the HVAD. A month after Medtronic acquired HeartWare FDA designated two of HVAD’s recalls as Class I. A year later, Medtronic expanded the recall, and initiated a new recall of a driveline splice kit used to repair the HVAD's driveline once an electrical break has been identified.
The biggest competitor to the medtech giant’s LVAD technology is Abbott Laboratories’ HeartMate. Abbott inherited the HeartMate device through its $25 billion acquisition of St. Jude Medical. The St. Paul, MN-based company obtained HeartMate through its acquisition of Thoratec in 2015 for about $3.4 billion.
At one point Thoratec once tried to acquire HeartWare but backed off because the deal was challenged by the Federal Trade Commission.