In January, Abbott announced the FDA approval of its HeartMate 3 left ventricular assist device (LVAD) via a less-invasive approach than open heart surgery, following a similar approval of Medtronic’s HeartWare HVAD pump almost one year ago.
GlobalData estimates that the mechanical circulatory support devices market for heart failure will reach $1.5bn by 2028 and the LVAD market will grow at a compound annual growth rate of approximately 6%. While the number of patients with end-stage heart failure continues to grow each year, GlobalData estimates that less than 5% are on a mechanical circulatory support device. Given the invasive nature of implanting an LVAD through open surgery, only a small percentage of patients are eligible to undergo the intervention.
A lateral thoracotomy involves an incision made between a person’s ribs to access the heart, as opposed to open surgery. This less-invasive approach results in fewer complications, less bleeding, and shortened recovery time, which may result in a rapid expansion of the patient pool as more patients will be able to receive an LVAD. With the FDA approval for implantation via lateral thoracotomy, GlobalData anticipates that smaller manufacturers may experience even more trouble maintaining their market share as Abbott and Medtronic will further dominate the LVAD market by providing a less-invasive treatment option.
The lateral thoracotomy approach provides the opportunity for more patients to receive an LVAD. While Medtronic had a head start in obtaining the FDA approval, Abbott’s HeartMate 3 was the market leader in 2019. GlobalData predicts that now that both companies are able to implant the device using a less-invasive approach, the market leader will be determined by which device demonstrates superiority in patient outcomes.