St. Jude Medical, Inc. (NYSE:STJ) today announced European CE Mark approval of its USB cellular adaptor for the Merlin@home™ transmitter, a system that allows important patient data from an implantable cardiac device to be wirelessly downloaded and securely transmitted via telephone for review by a physician. The new USB adaptor allows patients using a Merlin@home transmitter to transfer data to their physician over the cellular network, in addition to the existing landline service previously available.
“The USB Cellular Adapter expands the global reach of the Merlin.net PCN to new markets, particularly those markets that rely heavily on cellular technology”
“The USB cellular adaptor allows patients who frequently travel or relocate to be free of the restrictions of a traditional telephone line,” said Dr. Helen Høgh Petersen, of Rigshospitalet in Copenhagen, Denmark. “This addition to the remote monitoring system helps to ensure that patients can stay connected with their device follow-up clinic wherever they may live or travel.”
The USB cellular adaptor is a small device that plugs into new and existing Merlin@home transmitters. The transmitter typically sits on a patient’s bedside table and wirelessly communicates with the patient’s device during the night. Regularly scheduled follow-up appointments and daily device checks occur without any patient interaction required. This connectivity allows patients to limit the need for unnecessary visits to their physician’s office, but also allows physicians to more quickly become aware of any changes with the patient’s condition or device.
The Merlin@home transmitter is transportable and can transmit device data from anywhere with a mobile signal or landline and electrical power. The transmitter supports all radio-frequency (RF) St. Jude Medical implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), and the Accent™ RF pacemaker and Anthem™ RF CRT-P (cardiac resynchronization therapy pacemaker). The Accent RF pacemaker and Anthem CRT-P are the first and only pacemakers that provide complete remote and in-clinic follow-ups via wireless communication. The data from these devices are transmitted from the patient to the physician via the Merlin.net™ Patient Care Network (PCN), an Internet-based repository of patient and device data.
The need for data communication over the cellular network is particularly significant in Europe. According to a 2008 Eurobarometer E-communications Household Survey, nearly a quarter (24%) of all European households had only mobile phone access, and the mobile-only rate was even higher in the 12 newest European Union Member States (39%).
“The USB Cellular Adapter expands the global reach of the Merlin.net PCN to new markets, particularly those markets that rely heavily on cellular technology,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “This technology provides a reliable, secure transmission option that allows both patients and clinicians to experience the value of connectivity.”
Implantable cardiac devices are designed to capture and record information about device performance and patient heart rhythms that is vital to patient care. Merlin.net PCN organizes this information for fast analysis and easy review and allows data to be sent directly to a clinic's or a hospital's EHR system so the data can be included in the patient’s comprehensive personal health record. Alerts can also be set up by the physician, based on their preferences, notifying them of any urgent changes with the patient’s condition or device.
The data transferred using the Merlin@home device is fully encrypted and meets or exceeds all applicable national data privacy and security requirements in every country where we use the Merlin.net PCN. In addition, BSI Management Systems, an international standards, testing, registration and certification organization, has awarded St. Jude Medical the information security certification ISO/IEC 27001:2005. This ISO certification, a stringent worldwide information security standard, recognizes that St. Jude Medical’s Merlin.net PCN has established processes and standards that maintain the strictest levels of confidentiality, integrity and availability for its customers. The Merlin.net PCN is the first medical device data network to be recognized with this certification.
The Merlin.net PCN was also recognized as a silver winner of the 2009 Medical Design Excellence Awards, an award competition that is organized and presented by Canon Communications LLC and is the only awards program that exclusively recognizes contributions and advances in the design of medical products.
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