The decision is based on a growing body of observational clinical comparison, which showed a higher frequency of neurological adverse events with the system
Medtronic operational headquarters in Fridley, Minnesota, US. (Credit: Group29 at English Wikipedia)
Medical technology firm Medtronic has halted the distribution and sale of its Heartware Ventricular Assist Device (HVAD) system.
The company has urged physicians to stop using new implants of the HVAD system and focus on alternative means of durable mechanical circulatory support.
The decision is based on a growing body of observational clinical comparison, which showed a higher frequency of neurological adverse events and mortality linked to the system when compared to other commercially available devices.
According to the FDA, the action was implemented after the company secured more than 100 complaints involving delay or failure to restart the HVAD pump, including reports of 14 patient deaths and 13 cases where an explant was required.
In November 2012, the Medtronic HVAD system secured approval for commercial applications.
The device is already implanted in nearly 2,000 patients in the US and 4,000 worldwide.
At present, the system is indicated as a bridge to heart transplantation in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, as well as destination therapy in patients for whom a heart transplant is not planned.
The FDA’s Centre for Devices and Radiological Health cardiovascular devices office director Dr 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.”
The US federal agency has also advised patients who have the HVAD system to continue normal use of device components.
In December last year, Medtronic issued a voluntary recall for a subset of the HVAD pumps.