LivaNova has received 510(k) clearance for a modification to its Heater-Cooler System 3T designed to reduce the likelihood of infection during open cardiac surgery.
In a statement posted Tuesday, LivaNova said it has implemented the design modification on devices already in use and will incorporate the changes on all new units.
- LivaNova shared the news the day before it issued its fourth quarter results. Sales fell 3.2% on a reported basis in the quarter, causing revenues to fall short of analyst expectations.
LivaNova has been working to improve its Heater-Cooler System 3T since evidence of a safety risk emerged in 2015. The device is used to warm or cool a patient during cardiac procedures. In 2015, it became clear that the water the device uses to heat or cool the patient could escape through a vent. If contaminated, the aerosolized water could infect the patient.
The discovery of the problem led LivaNova to modify the design of the device and offer a cleaning service to organizations with contaminated units. FDA said the changes “have been shown to reduce the risk of patient infection.”
LivaNova’s 510(k) submission covers a device that incorporates all of the corrections implemented by the company in recent years. In addition, the device comes with updated labeling and new, validated instructions for cleaning and disinfection.
FDA wants users of older versions of the device to immediately adopt the updated labeling. These organizations have had access to the vacuum canister and internal sealing design change LivaNova put in place to cut the risk of contamination since late 2018. At that time, LivaNova said it would contact users to arrange the modification of affected products.
The advice for organizations with devices manufactured before Sept. 2014 is different. FDA wants users of those older products to “strongly consider transitioning away from the use of these devices for open-cardiac surgery unless your device has been deep cleaned specifically by LivaNova.”
News of the 510(k) clearance emerged the day before LivaNova published its fourth quarter results. LivaNova posted fourth quarter sales of $288 million, down close to $10 million compared to the same period of 2018 and around $5 million short of the analyst consensus. CEO Damien McDonald attributed the results to “an unexpected component supplier issue for oxygenators and execution challenges in the Rest of World region relating to distribution model changes.”
LivaNova reported a fourth quarter operating loss of $144 million, in large part due to charges of $100 million tied to the discontinuation of its transcatheter mitral valve program. Litigation related to the Heater-Cooler System 3T accounted for another $33 million of the operating loss.