Medtronic PLC is discontinuing all implants of one of its most complex and costly heart-failure devices, the HeartWare Ventricular Assist Device, five years after the Minnesota device maker acquired the HVAD's maker in a $1.1 billion deal.
Medtronic and the U.S. Food and Drug Administration announced Thursday that the device should no longer be implanted following reports that the system — which circulates oxygenated blood when the patient's heart is failing — is associated with more deaths, strokes and device problems than a competing system made by Abbott Laboratories.
Medtronic has reported more than 100 patient complaints involving a delay or failure in restarting the devices' implantable blood pump, "which led to a total of 14 deaths and 13 pump removals," the FDA says. About 2,000 HVADs are currently implanted in the U.S., out of 4,000 implants worldwide.
"Medtronic initiated this action in light of a growing body of observational clinical comparisons indicating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD System," Medtronic said in its statement. "Considering these findings and the availability of alternative devices, Medtronic made the decision to stop the distribution and sale of the HVAD System."
The HVAD is intended for advanced-stage heart failure patients. Initially approved as a temporary "bridge" to full heart transplant, such devices are now allowed to be implanted as a "destination" therapy, with no intention of removing it.
Unlike implantable pacemakers and defibrillators, which restore a normal heart beat and cost several thousand to several tens of thousand dollars, a ventricular-assist device pumps a patient's blood for them and carries a six-figure price. A 2017 analysis found the mean cost of purchasing and implanting a ventricular assist device was $175,000.
Medtronic refers to its device as the Medtronic HVAD System, while the FDA calls it the HeartWare Ventricular Assist Device — named for its former manufacturer, HeartWare International, which Medtronic acquired in 2016.
The HeartWare system has been the subject of numerous serious recall actions over the years, including three Class I recalls this year, according to industry publication MedTech Dive.
For patients who already have the device implanted, Medtronic is not recommending it be removed because the risks of "explantation" may outweigh the benefits of surgical removal. Instead, the company recommends patients and physicians consult their guide to next steps, which is at Medtronic.com/HVADsafety.
"Medtronic reminds you to never disconnect your HVAD pump from two power sources at the same time and to always have a back-up controller and fully charged spare batteries available," the company advice says. "Medtronic will provide ongoing product support for the HVAD System and will ensure continued availability of peripherals, including the Pioneer controller."
The device controller is outside the body, while the pump is implanted. The company said it will continue to provide product support to patients, who may need support for "many years" to come.
Medtronic said its support program will include "financial assistance for eligible patients," though details are not yet available.
The company said it's working closely with one of its key competitors, Abbott Labs, "to help ensure that alternative treatment options are available for patients who may be candidates for a LVAD device." (Abbott refers to its device as an LVAD, or left-ventricular assist device.)
On Thursday, Abbott issued a statement confirming it is ready for an influx of new patients.
Financial analysts with SVB Leerink in Boston wrote that Medtronic's decision to end sales of the HVAD was not surprising, given that the system had seen revenue decline to $141 million in the most recent fiscal year, meaning its HVAD business was operating at a loss.
Removal of the system was already contemplated in Medtronic's financial guidance for fiscal 2022.
Medtronic shares were little changed Thursday, closing at $123.07.