Certain pacemakers and implantable defibrillators made by Medtronic Inc. (NYSE:MDT) can’t be sold in the U.S., but the company can’t figure out why.
The Fridley, Minn.-based company received a warning letter from the Food & Drug Administration a year ago, regarding the devices’ manufacture, that’s still blocking their sale.
Medtronic CEO Bill Hawkins told The Wall Street Journal that his company is "’in constant dialogue with FDA’ but [doesn’t] have insight into where the agency is in its review process." Medtronic has given the FDA lots of information in response to issues raised by the agency, Hawkins said, and "they’re reviewing all that data and we’re waiting for them to make a decision."
The FDA’s Nov. 2009 warning letter said that Medtronic’s "methods used in, or the facilities or controls used for, [the devices’] manufacture, packing, storage or installation are not in conformity with the Current Good Manufacturing Practice requirements of the Quality System regulation." The agency later re-inspection the Minnesota facility, but Medtronic is still waiting for a response, according to the Journal.
The pacemakers in question, which are designed to work safely in MRI scanners, and implantable defibrillators designed to reduce unnecessary shocks, are both approved for sale in Europe.
In other Medtronic news, the company yesterday completed its takeover of Eatontown, N.J.-based bone-regenerative products maker Osteotech Inc. for about $123 million in cash, according to the company.
Medtronic Biologics general manager Tom McGuiness called the deal, which the company announced in August, "an important step in building a broader business in regenerative biologics."
“The acquisition complements our bone healing portfolio and will expand our current presence in spine, orthopedic trauma and dental into new treatment areas,” McGuiness said in prepared remarks.
The medical devices giant, which has announced acquisition deals for nine different companies since 2009, has had trouble turning its new portfolio additions into profits. Its first-quarter sales rose just 2 percent, prompting the company to reduce its sales and profit forecasts for 2011, and some analysts suspect Medtronic will further lower that guidance when the company reports second-quarter earnings next week.