Medical Devices of interest to Skyaid -2000

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Medical Device Announcements of interest to Skyaid added12/24/00

From http://www.mdbinfonet.com/pnews.asp

Medtronic Announces FDA Clearance of New Generation GEM Defibrillators 12/15/00

Medtronic, Inc., announced that the FDA has approved commercial release in the U.S. of the first model in a new generation of its implantable cardioverter-defibrillators (ICDs). The Medtronic GEM® III DR ICD (Dual Chamber Model 7275), used with Medtronic Sprint™ defibrillation leads and the Medtronic 9790 programmer, inaugurates a family of implantable systems with advances in detection, device longevity, and diagnostic capabilities. The system is designed to treat potentially lethal heart rhythms such as sudden cardiac arrest. The new dual-chamber GEM III DR device is intended for patients with conditions requiring that sensing take place in the upper chamber of the heart as well as in the lower chamber to assure that the device circuitry correctly evaluate arrhythmias to prevent inappropriate therapeutic impulses.

Medtronic is awaiting FDA clearance of the single-chamber GEM III VR (Model 7231) for use with patients who do not require upper-chamber sensing and pacing. The FDA is also reviewing the GEM III AT system for managing tachyarrhythmias in both upper and lower chambers of the heart. Medtronic, Inc.'s Internet address is www.medtronic.com.

New Medtronic System Connects Doctors and Heart Patients Via Internet 9/15/00 no real-time alarms

Medtronic, Inc., announced the first use of its new patient management system designed to capture critical physiologic information from a heart failure patient's implanted medical device in his or her home and deliver it to the attending physician via the Internet. The new Medtronic.com Patient Management System for heart failure patients employs the Medtronic Chronicle® device that is intended to continuously sense and collect valuable information such as intracardiac pressures, heart rate, and physical activity from a proprietary sensor placed directly in the heart's chamber. The patient periodically downloads this information to a home-based device that transmits this critical physiologic data securely over the Internet to the Medtronic Patient Management Network. Physicians can access the network via a website at any time and review screens that present summary information from the latest download, trend information, and detailed records from specified times or problem episodes. The Chronicle Patient Management System is currently undergoing investigational trials in the United States and Europe, and is not yet approved for commercial sale.

Medtronic also announced that two world-class information technology companies would help deploy the Patient Management Network. UUNET will provide network services and Exodus Communications™, Inc. will host and manage the Patient Management System's applications and servers. These companies supplement a previously announced strategic relationship with Microsoft, which is providing the platform technologies Medtronic is using to build and run the Patient Management Network. For more information, see: www.medtronic.com.

Protocol Introduces FlexNet and Micropaq 3/15/00

Protocol Systems Inc., has introduced the FlexNet™ wireless patient monitoring network, which provides vital signs data and patient information, including secure access over the Internet. FlexNet links multiple devices such as wireless portable monitors and ambulatory telemetry monitors, to central surveillance workstations and/or to remote PCs via the Internet. Unlike traditional RF telemetry, which can exhibit bandwidth limitations when supporting multiple patients, monitoring devices, and vital signs parameters, FlexNet can facilitate the communication of multiple monitoring devices. It is fully configured with a comprehensive complement of vital signs parameters including heart rate, ECG, pulse oximetry, noninvasive and invasive blood pressure, respiration, and capnography. In addition, other devices such as Internet protocol (IP) telephones, personal digital assistants (PDAs), and wireless PCs can be simultaneously supported on the same wireless FlexNet LAN and/or WAN.

Protocol has also introduced the wireless Micropaq™ ambulatory patient monitor. The Micropaq monitor combines the functionality and form of a patient-worn telemetry monitor with the display, alarms, and parameters of a standalone portable vital signs monitor. It is principally designed for use in cardiac care with ambulatory patients connected wirelessly to Protocol's FlexNet™ network and the Acuity® central nursing workstation. However, the monitor is also appropriate for a number of monitoring applications outside of cardiac care because it provides a liquid crystal display (LCD) of vital signs data and will operate outside of the wireless network. The Micropaq monitor can be used as a portable or spot-check monitor on hospital medical-surgical floors or as a basic transport monitor when critical care patients are moved from one hospital department to another.

The Micropaq is extremely rugged; it is waterproof and weighs less than one pound with its batteries. It uses rechargeable lithium ion batteries that provide 18 to 30 hours of operation depending upon use. Protocol has also incorporated Masimo signal extraction technology (SET®) pulse oximetry into the Micropaq. This patented adaptive filtering technology provides accuracy of pulse oximetry measurements even in the presence of patient motion artifact and low perfusion.

Protocol expects FlexNet and Micropaq to be available for customer shipments in the fourth quarter of 2000 pending FDA clearance. A later version of Micropaq, including a noninvasive blood pressure option featuring Protocol's Smartcuff™ patient motion artifact resistant technology, is expected next year.