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| Puritan Bennett 980 Ventilator--Courtesy of Covidien |
Covidien ($COV) won CE mark approval in Europe for its new acute care ventilation system.
The Puritan Bennett 980 ventilator incorporates innovative technology that helps clinicians monitor patients' breathing. The device includes a user interface with a customizable display screen, an integrated expiratory filtration system and advanced synchrony tools that help physicians control settings. Patients ranging from neonatal to adult can use the ventilator.
"We are excited to introduce our next-generation acute ventilation platform, the Puritan Bennett 980 ventilator," said Cristiano Franzi, president of Covidien Europe, in a statement. "Building on Covidien's strong legacy of innovation, the Puritan Bennett 980 ventilator will provide clinicians with a simple, safe and smart way to care for patients."
Approval for the device marks a positive development after Covidien experienced a string of failures related to its ventilator products: In May 2013, the FDA slapped Covidien with a Class I tag for battery packs used with its Newport HT70 ventilators. The company had recalled the battery packs one month prior after discovering that certain lots failed to charge or prematurely reverted to emergency backup power, putting patients at risk for injury or death.
Earlier this year, Covidien was hit with another Class I label for a software issue in one of its ventilators. The company had launched a voluntary recall of its Puritan Bennett 840 Series ventilator in December 2013 after finding that a software problem could trigger a diagnostic code that would shut the device down, leaving patients to breathe on their own.
Despite regulatory setbacks, Covidien is trying to bounce back: In February 2014, the company closed its $860 million buyout of Given Imaging, gaining coveted access to Given's PillCam endoscopic capsule. The acquisition was also part of the company's greater plan of expanding its presence in specialty markets, Bryan Hanson, group president of the company's Medical Devices and U.S. arm, said in an earlier statement.
The company's Puritan Bennett 980 ventilator was also approved for commercial distribution in the U.S., Japan and Canada. If all goes according to plan, the device will be available for sale in those countries as well as the European Union in upcoming months, the company said in a statement.
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