Sorin Group (BIT:SRN) said it won CE Mark approval in the European Union for its Kora 100 DR and SR pacemakers.
Milan-based Sorin said the devices feature an automatic MRI mode when implanted with the Sorin Beflex pacing lead. This allows the device to safely operate during an MRI examination when the Kora 100 detects the scanner’s magnetic field, according to a press release.
“The Kora 100 pacing system with the automatic MRI mode provides benefits to our patients, the cardiology practice, and to my colleagues in radiology. Because the pacemaker only operates in MRI mode during the actual MRI procedure, I can be more flexible in scheduling my pre-MRI visits. Since the pacemaker automatically switches back to the pre-programmed settings without further intervention, the radiologists can be confident about patient safety after the imaging procedure,” Dr. Harald Mayr of Landesklinikum St. Pölten, Austria, said in prepared remarks.
It’s the latest in a string of regulatory wins for the Italian medical device maker across the pond. Sorin won CE Mark approval for its Perceval sutureless aortic valve and its Solo Smart aortic heart valve last month.
In October, Sorin’s 3rd-quarter profits soared some 7,200% on sales growth of 12.4% as it finalized its recovery from a pair of earthquakes last year.
Milan-based Sorin reported profits of €14.6 million, or $20.2 million, on sales of €180.3 million, or $249.0 million, for the 3 months ended Sept. 30. Adjusted to exclude 1-time items, profits were €15.7 million, or $21.7 million.