Abbott’s problems with its HeartMate LVADs continue to grow, this time involving system monitors. In an urgent field safety notice recently published in Germany, Abbott said it has received 299 complaints of the HeartMate system monitor screen displaying atypical behavior. The company added that there have been no reports of serious adverse health consequences. The […]
LVAD
Abbott has another serious LVAD recall
The FDA today labeled Abbott’s recall of some HeartMate II and HeartMate 3 left ventricular assist systems (LVAS) as Class I, the most serious kind. Abbott issued the recall of the HeartMate II and HeartMate 3 LVAS due to an issue known as extrinsic outflow graft obstruction (EOGO). The issue happens when biological material builds […]
CorWave raises $64M as it prepares to manufacture its LVAD
CorWave announced today that its Series C round has brought in a total €61M ($64 million) to fund entry into clinical trials and initial manufacturing of its wave membrane LVAD. The French LVAD developer said it will soon inaugurate manufacturing at its facility on the banks of the Seine River in Clichy. The French government’s […]
LVADs save lives: So why aren’t more available?
Abbott says its HeartMate 3 LVAD is clinically proven to extend life by five years or more — but thousands of people in the U.S. still die of heart failure within a year. Kyree Miller, a 30-year-old college student, navigated seven long years of heart failure with the assistance of an Abbott HeartMate left ventricular […]
Another Medtronic HVAD recall is serious
A year after Medtronic ceded the LVAD market to Abbott, it has yet another Class I recall involving HeartWare Ventricular Assist Device pumps still implanted in patients. The FDA today designated a Medtronic recall involving the HVADs as Class I, the most serious level. It’s the second Class I recall designation for the HVADs this […]
Medtronic stops sales of its HVAD system
Medtronic (NYSE:MDT) announced today that it has stopped distributing and selling its HeartWare Ventricular Assist Device (HVAD) system. Fridley, Minn.-based 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. […]
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 […]