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International News In Brief

St. Jude Brio pulled from overseas markets. Another U.K. metal-on-metal hip alert. More international device news.

St. Jude Medical Inc. has temporarily pulled its Brio deep brain stimulation implantable pulse generator off the market in Europe, Australia and Latin America due to a “fixable” problem, the firm said April 2. The device, launched in 2010, treats symptoms in patients with Parkinson’s disease. St. Jude received 11 reports of Brio “exhibiting lower than expected impedance of readings leading to therapy degradation.” In eight of the patients, the device was explanted and a new one was implanted, the company said. Currently, 400 patients have the device in Europe. St. Jude has issued a product field corrective action and expects Brio to be unavailable for 60-90 days while the problem is addressed, but hopes for it to be available again “as soon as possible, subject to any applicable regulatory approvals.” The product has not received U.S. approval.

The U.K.’s Medicines and Healthcare products Regulatory Agency issued a medical device alert to surgeons April 2 urging them to stop implanting MITCH TRH total hip replacement cups/heads...

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