Medtronic (NYSE:MDT) announced today that it has stopped distributing and selling its HeartWare Ventricular Assist Device (HVAD) system. Fridley, Minn.-baed Medtronic this morning issued a notice to physicians informing them to stop new implants of the HVAD system and to transition to an alternative means of durable mechanical circulatory support, according to a news release. […]
LVAD
Medtronic has another serious HVAD recall
The FDA is reporting 12 deaths related to a recall of Medtronic (NYSE:MDT) HeartWare Ventricular Assist Device controller ports. The recall — which Medtronic initiated on Feb. 26 and FDA designated as Class I — is related to 855 complaints and eight reports of injuries, according to the FDA. Medtronic said today that the FDA’s […]
Are Black patients not getting LVADs as quickly as white patients?
Researchers from the University of Missouri conducted a study that found disparities in treating Black and white patients with advanced heart failure. According to a news release, the study found that Black patients with advanced heart failure were more likely to receive a left ventricular assist device (LVAD) — a pump implanted into the chest […]
CMS proposes coverage updates that could increase access to VADs
The Centers for Medicare & Medicaid Services (CMS) today proposed coverage policy updates meant to increase access to VADs and artificial hearts. The policy updates, if approved, could be good news for major VAD makers Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) — as well as people with heart failure who are waiting for a heart transplant or don’t […]
Abbott LVAD wins FDA approval for implantation without open heart surgery
Abbott (NYSE:ABT) today announced that FDA has approved implantation of its HeartMate 3 LVAD via lateral thoracotomy — a less invasive approach than open-heart surgery. The approval comes about a year and a half after Medtronic (NYSE:MDT) won a similar approval for the competing HeartWare HVAD pump. Lateral thoracotomy involves a surgeon making an incision between a person’s […]
