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| 3T Heater-Cooler System--Courtesy of Sorin Group |
Shares of London's LivaNova are down more than 8% since it was hit by a dreaded Dec. 29 FDA warning letter related to its Arvada, CO, and Munich, Germany, facilities. The company went into damage-control mode, explaining the (admittedly dense) letter to jittery investors and claiming that the "FDA's concerns can be resolved without a material impact on the company's financial results."
The FDA said an inspection of the Munich facility revealed several violations of its Quality System regulation related to manufacturing of 3T Heater-Cooler thermal regulators. They include failure to establish and maintain procedures for the documentation or approval of design changes before their implementation, failure to validate a manufacturing process for disinfection and failure to adequately develop and maintain written medical device reporting procedures about adverse events and device-related injuries.
The warning letter was issued as a result of an August 2015 inspection of the facility that resulted in a Form 483 being issued by the agency, which identified two observed nonconformities with certain regulatory requirements, according to the company release. The letter responded to LivaNova's apparently nonsatisfactory response to the Form 483 and listed new alleged violations.
LivaNova, recently formed from merger of cardiology specialist Sorin Group and neuromodulation specialist Cyberonics, said less than 1% of 2016 sales could be impacted by the warning letter.
"The Company will continue to work diligently to remediate FDA's inspectional observations for the Munich facility as well as the additional issues identified in the Warning Letter. The Company takes these matters seriously and intends to respond timely and fully to FDA's requests," LivaNova said in a statement.
It stressed that the warning letter does not affect other devices or any premarket approval applications, and that the FDA did not request users to stop using the 3T Heater-Cooler.
Used in conjunction with heart-lung machines during invasive cardiac surgery requiring cessation of the heart, the 3T Heater-Cooler is used to warm or cool the blood so that it stays at an appropriate temperature during the operation.
The product website shows that in June, Sorin issued a field safety notice providing updated instructions for 3T Heater-Cooler disinfection and maintenance due to the possibility of bacterial contamination of the device.
- read the release
- read FDA's warning letter
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