Lake Oswego, OR - The first wireless communication system for remote monitoring of implantable pacemakers won FDA approval yesterday. The Biotronik Home Monitoring System allows a Biotronik pacemaker to automatically transmit critical data about the patient's current condition to his or her physician's office, anytime, anywhere.
Like other pacemakers, the Biotronik pacemaker records the heartbeat of the patient, plus any significant cardiac events such as sustained ventricular tachycardia, and the activity of the pacemaker itself. A transmitter in the Biotronik machine can send this information to a special receiver that then makes a cellular phone call to a central computer at Biotronik (Lake Oswego, OR) and downloads the data. That data is then faxed as a full report directly to the doctor's office. The entire process occurs without the patient's involvement.
How often the pacemaker transmits data is up to the doctor according to the patient's needs. The only limitation is the limited transmission range of the pacemaker. The receiver must be within 6 feet of the patient in order to receive the data. The receiver is roughly the size of a cell phone and can be carried around easily if needed.
In order to ensure smooth, uncorrupted data transmission, Biotronik is taking advantage of the Medical Implant Communication Service (MICS), a range of radiofrequency bandwidth dedicated for use by implanted medical products. MICS is regulated by the Federal Communication Commission, and provides an isolated pathway for transmission free of environmental interference. To further safeguard the integrity and privacy of the data, Biotronik will be using multiple proprietary security and encryption protocols.
Although the system has won FDA approval, Biotronik is going to restrict the first 100 sales to patients at 10 medical centers that will study the ease and effectiveness of the system in a real-world situation.
For now, the system is only available with Biotronik's dual chamber, rate-responsive pacemakers, at a cost of around $5000. Biotronik expects to have the system available for use with implantable cardiac defibrillators in 2002.
Heartwire from Medscape © 2001
Cite this: FDA approves Biotronik Home Monitoring System pacemaker - Medscape - Oct 12, 2001.