par John R. Fischer
, Senior Reporter | June 09, 2021
Medtronic has pulled its HeartWare ventricular assist device (HVAD) system off the market following growing evidence that connects the implant to higher rates of neurological adverse events.
Designed to provide hemodynamic support in patients with advanced, refractory left ventricular heart failure, the company has told physicians to stop using new implants for the HVAD system and instead use alternative mechanical circulatory options.
“There is nothing more important than the safety and well-being of patients. We recognize this information may be concerning for patients and their caregivers, and Medtronic is committed to supporting them in coordination with their physicians,” said Nnamdi Njoku, president of the mechanical circulatory support business, which is part of the cardiovascular portfolio at Medtronic, in a statement.
The FDA has also issued its own warning. "We have been carefully monitoring the adverse events associated with this device and support its removal from the marketplace," said Dr. Bram Zuckerman, director of the office of cardiovascular devices in the FDA’s Center for Devices and Radiological Health.
Observational clinical comparisons have linked the HVAD system more than other circulatory support devices to adverse neurological incidents, including stroke and mortality. The company also previously issued an Urgent Medical Device Communication to inform physicians that the HVAD pump may experience a delay in restarting or fail to restart after it stops. This can lead to heart conditions worsening and put patients at risk for heart attacks, hospitalization and death.
For those who have been implanted with an HVAD, a support program will be set up by the company for them and their caregivers. Developed by an independent panel of clinician advisors, the program will help ensure ongoing care and safety for the approximately 4,000 HVAD patients. The panel will also provide patient management recommendations to help reduce risk for stroke and other possible issues associated with the system.
Elective explants of the device are not recommended due to the risks associated with explanation potentially outweighing the benefits.
The company is working with the FDA and other regulatory bodies worldwide to inform providers of its decision to halt sales and distribution of its HVAD device. It is also working with stakeholders, including Abbott, developer of the HeartMate 3 LVAD device, to ensure alternative treatment options are available to patients who may be candidates for LVAD implants.
In a separate announcement, Abbott said it has the "capacity and supply" to support the expanded need for its HeartMate 3 solution following the withdrawal of Medtronic's HVAD device. "Ensuring continued access to these devices is critical for patients," said Mike Pederson, senior vice president of Abbott's electrophysiology and heart failure business. "We are working to ensure that physicians have the support and training they need as they further adopt HeartMate 3 to improve outcomes for their advanced heart failure patients."
The HVAD system and associated accessories drew in $141 million in the fiscal year 2021 for the company. It’s withdrawal from the market is expected to be neutral to slightly accretive to Medtronic's fiscal year 2022 non-GAAP diluted earnings per share.