Medtronic has announced that the company is discontinuing the supply and marketing of its HeartWare ventricular assist device (HVAD) due to a high incidence of neurological adverse events.
The HVAD system is indicated for hemodynamic support in advanced, refractory left ventricular heart failure patients. It is used either as a bridge to cardiac transplantation, myocardial recovery or as destination treatment in those patients with no transplantation planned.
Medtronic’s decision follows more than 100 complaints that the company received on the delay or failure to restart the HVAD pump. These complaints include 14 deaths and 13 cases of explant.
The company is currently creating a support programme for patients with an HVAD implant as well as for the care providers and healthcare experts involved in their care.
An independent team of clinician advisors is developing the programme with a focus on the ongoing care and safety of patients with the HVAD system.
The company also alerted doctors to stop new implants of the system and shift to an alternate option of durable mechanical circulatory support.
There are nearly 2,000 patients in the US who are implanted with the HVAD and 4,000 globally, Medtronic noted.
The plan to discontinue the HVAD system is based on observational clinical comparisons showing an increased incidence of neurological adverse events, such as stroke, as well as mortality with the device, versus other available circulatory support devices.
Medtronic mechanical circulatory support business president Nnamdi Njoku said: “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.”
This announcement follows Medtronic’s decision to stop the sale of HVAD.
Last month, Medtronic received CE mark for its Evolut PRO+ TAVI System in Europe to treat patients with symptomatic severe aortic stenosis.