Medtronic’s decision to stop the sale and distribution of the HVAD follows its voluntary recall of a subset of the HVAD pumps in December 2020
Medtronic HeartWare HVAD pump in hand. (Credit: Medtronic.)
Medtronic has stopped the distribution and sale of its Heartware Ventricular Assist Device (HVAD) System and requested physicians to stop new implants of the device.
The HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure, and was first approved in the US, in November 2012.
It is currently approved to bridge heart transplantation in patients who are at risk of death from end-stage left ventricular heart failure, and for whom a heart transplant is not planned.
Medtronic’s decision to stop the sale and distribution of the HVAD follows its voluntary recall of a subset of the HVAD pumps in December 2020.
The decision is based on frequently reported adverse events and mortality with the system, along with complaints of delay and failure of the internal pump to restart.
Medtronic mechanical circulatory support business president Nnamdi Njoku said: “The Medtronic Mission guides us to always do what is in the best interests of patients and that is exactly what we are doing and will do for those impacted by this decision.
“There is nothing more important than the safety and well-being of patients. We recognise this information may be concerning for patients and their caregivers, and Medtronic is committed to supporting them in coordination with their physicians.”
The US Food and Drug Administration (FDA) has urged health care providers to refrain from implanting end-stage heart failure patients with Medtronic’s HVAD System.
It advised health care providers to follow the instructions provided in Medtronic’s Urgent Medical Device Communication Notification Letter.
FDA said that it will continue to monitor adverse events related to HVAD System and will update health care providers and the public with any further information.
The US regulator urged health care professionals and patients to report adverse events or safety problems with the Medtronic HVAD System.
In response to Medtronic’s decision to stop the sales of the HVAD system, Abbott announced that it can support the demand for mechanical circulatory support (MCS) devices for the treatment of advanced heart failure.
It is providing training and education programmes for physicians who will provide its Heartmate 3 Left Ventricular Assist System (LVAS) as an alternative.
FDA centre for devices and radiological health office of cardiovascular devices director Bram Zuckerman said: “The FDA’s highest priority is patient health and safety.
“We have been carefully monitoring the adverse events associated with this device and support its removal from the marketplace.
“The FDA is working closely with both Medtronic and Abbott to ensure patient care is optimized during this transition period and that there is an adequate supply of devices available to provide this patient population with options for end-stage heart failure treatment.”
Furthermore, Medtronic is developing an ongoing support programme for patients who already undergone HVAD implantation, caregivers, and health care professionals.