The Swedish medical device giant signed a consent decree with the FDA’s Center for Devices & Radiological Health that means a temporary halt for some products made at its Atrium Medical operation in Hudson, N.H., according to the company and court documents, although Atrium can continue making products deemed "medically necessary" by the FDA. The closure is expected to hit Getinge’s operating profits by about $61 million, or 500 million kroner, the company confirmed today.
"Patients must be assured that medical devices are safe, effective and high quality," acting director of CDRH’s Office of Compliance Jan Welch said in a statement. "The FDA will remain vigilant in bringing companies that do not meet our regulatory requirements back to a sustainable state of compliance."
The ruling means Atrium’s ProLite, ProLoop and C-QUR hernia meshes, its Flixene vascular graft and its Ivena vascular patch will be off the market until the issues are resolved, the FDA said.
“We have learned from this experience, and this agreement with the FDA provides us with a clear path forward," CEO Johan Malmquist said in prepared remarks. "We have taken this situation very seriously and have committed substantial investments into the quality management system. The remediation work is well underway and has already led to significant improvements."
News of the consent decree sent Getinge shares up 3.6% to about $28.38 (219.50 kr) in early trading today. Getinge acquired Atrium in 2011 for $680 million.
The settlement stems from FDA inspections in 2012 and 2013 at Atrium’s Granite State facilities and at plants in Wayne, N.J., and in Hechingen and Rastatt, Germany, according to filings with the U.S. District Court for New Hampshire. Inspections at the Atrium plant in 2013, after an October 2012 warning letter, still found problems, according to the filings.
Inspections at the New Jersey plant during the same period in 2013, following warning letters in 2010, also turned up violations, as did FDA inspections in Hechingen and Rastatt during September 2013. The German plant inspections resulted in Form 483 warnings to Maquet, according to the filings.
Maquet Cardiovascular is still facing a warning letter issued Dec. 4, 2014, for marketing its CardioHelp extracorporeal membrane oxygenation without pre-market approval from the FDA. The agency requested that CardioHelp, which was cleared via 510(k) in 2011, be taken off the U.S. market until its PMA requirements are met.