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St Jude Medical wins CE Mark for new cardiac pacemakers
May 15, 2009 (Datamonitor via COMTEX) --
St Jude Medical, a developer and manufacturer of cardiovascular medical devices, has obtained European CE Mark approval for its Accent RF pacemaker and Anthem RF cardiac resynchronization therapy pacemaker.
According to St Jude Medical, the Accent and Anthem product family features RF telemetry that enables secure, wireless communication between the implanted device and the programmer used by the clinician, making it the first integrated system of pacing devices with wireless telemetry from implant through follow-up.
Wireless communication is used when clinicians implant the device and during follow-up appointments, which can be performed in the office or via remote monitoring with the patient at home, allowing for more efficient and convenient care and device management.
The remote monitoring capabilities facilitated by the Accent RF and Anthem RF device product line will permit automated follow-up, and daily device safety checks with no patient action required. In addition to giving physicians fast access to device performance data, the wireless monitoring system will also allow physicians to compile a more complete patient record by easily transferring cardiac device data into electronic health records (EHRs), said St Jude Medical.
In addition, the Anthem RF cardiac resynchronization therapy pacemaker and Accent RF pacemaker include advanced automatic features that help to promote patient safety and efficiency for the clinician. The devices can be programmed to automatically monitor and adjust the level of electrical energy needed for stimulating the patient's heart, in the chambers where therapy is delivered; this includes up to three chambers for cardiac resynchronization therapy, the company added.
The Merlin.net Patient Care Network version 4.0, which will support the Accent RF and Anthem RF remote monitoring capabilities, is expected to be approved by mid-summer of 2009.
Eric Fain, president of the St Jude Medical cardiac rhythm management division, said: "The introduction of the Accent RF and Anthem RF products represents the next step taken by St Jude Medical in healthcare connectivity involving implantable devices.
"We designed the pacemakers in response to the physician and patient needs for intelligent products that streamline testing and follow-up, as well as to facilitate an exchange of information between the physician and patient. Using the remote monitoring capabilities, physicians will be able to stay abreast of device function and the patient's condition, enabling a more timely response to the patient's evolving needs."
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