LVAD Archives - Medical Design Sourcing

Another Medtronic HVAD recall is serious

Medtronic’s HVAD [Image courtesy of Medtronic]

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 month.

This time around, the Class I recall involves a potential welding defect affecting a specific lot of external batteries for the HVADs. Medtronic became aware of complaints that the battery had stopped providing power or failed to hold a charge. The medtech giant is retrieving the affected lot of batteries and replacing them.

“The wellbeing and experiences of patients implanted with the HVAD pump are vitally important to us. Although Medtronic no longer distributes the HVAD System, we are committed to…

Another Medtronic HVAD recall is serious

Medtronic’s HVAD [Image courtesy of Medtronic]A year after Medtronic ceded the LVAD market to Abbott, it has yet another Class I recall involving its HeartWare Ventricular Assist Device pumps still implanted in patients.

The FDA today designated a Medtronic recall involving the HVADs as Class I — its most serious level. It’s the second Class I recall designation for the HVADs this month.

This time around, the Class I recall involves a potential welding defect affecting a specific lot of external batteries for the HVADs. Medtronic became aware of complaints that the battery had stopped providing power or failed to hold a charge. The medtech giant is retrieving the affected lot of batteries and replacing them.

“The wellbeing and experiences of patients implanted with the HVAD pump are vitally important to us. Although Medtronic no longer distributes the HVAD System, we are committed to ongoing quality assessments and control measures to furt…

Medtronic has another serious HVAD recall

Medtronic’s HVAD [Image courtesy of Medtronic]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 figures are inaccurate.

The HVAD pump helps the heart continue to pump blood to the rest of the body, providing a bridge to cardiac transplants among people at risk of death from end-stage left ventricular heart failure. HVADs can also support heart tissue recovery and provide a destination therapy when there are no plans for new transplants.

The latest recall involves battery cables, data cables, adapter cables and controller 2.0 ports for HeartWare, according to FDA. Wear and tear of the connector plugs (power sources, data cable, and alarm adapter) can damage the controller …

Are Black patients not getting LVADs as quickly as white patients?

[Image from Wikimedia Commons]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 to help blood flow throughout the body — later in their disease progression when compared to white patients, ultimately resulting in worse health outcomes.

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Are Black patients not getting LVADs as quickly as white patients?

[Image from Wikimedia Commons]

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 to help blood flow throughout the body — later in their disease progression when compared to white patients, ultimately resulting in worse health outcomes.

MU School of Health Professions associate professor Adrianne Frech and fellow co-authors of the study analyzed data from the United Network for Organ Sharing (UNOS) that covered patients who received an LVAD as a temporary “bridge” solution to their heart failure while on a waiting list to receive a permanent heart transplant between 1999 and 2014.

Frech and the …

CMS proposes coverage updates that could increase access to VADs

Abbott’s HeartMate 3 LVAD [Image courtesy of Abbott]

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 meet the criteria for one.

“CMS’ proposed revisions to its national coverage determination (NCD) for ventricular assist devices are very promising for people living with advanced heart failure. Providing patients with greater access to this technology is important as heart pumps can have a critical impact on saving and improving quality of life. We look forward to CMS’ final decision in the months ahead,” Dr. Robert L. Kormos, divisional VP of global medical affairs for Heart Failur…