|St. Jude is launching its Accent MRI pacemaker in Japan.--Courtesy of St. Jude|
St. Jude Medical ($STJ) won Japanese approval for an MRI-friendly pacemaker and lead, the only combo cleared for full-body scans on the country's market, the company said.
The Accent MRI pacemaker and the Tendril MRI lead allow physicians to set custom parameters for each patient before undergoing an MRI, programing the device to alter its function during the procedure and switch back once the scan is complete, St. Jude said.
Medtronic ($MDT) was first on the Japanese market with an MRI-safe pacer, launching the Advisa DR MRI SureScan in October, but Accent MRI's customizability and wider indication will allow St. Jude to snatch a share of local demand, Senior Vice President William Phillips said.
"The Accent MRI pacemaker has many advantages over what is currently available for patients," Phillips said in a statement. "The sophisticated pacemaker functionality and labeling of full-body MRI scans are especially important for patients who may need an MRI scan in the chest and abdominal area."
Accent MRI's Japanese debut has come right on schedule, as St. Jude plans to launch more than 20 new products this year in an effort to bolster some faltering revenues. The Minnesota devicemaker is still in the throes of an ongoing slump in cardiac rhythm management sales, and, last quarter, the business slipped 8%, with ICD sales dropping 5% and pacemaker revenue plummeting 12%.
For the year, St. Jude expects its CRM revenue to come in about 4% under 2012, but the company has faith its MRI-safe entré into Japan will pad sales, and it's plotting to launch the world's first lead-less pacemaker in Europe later this year. St. Jude is in the midst of an FDA-targeted trial for Accent MRI, studying about 800 patients with the goal of U.S. approval.
- read the announcement
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