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ISSYS Awarded NIST ATP for Advanced Medical Devices

Ypsilanti, MI --Integrated Sensing Systems, Inc. (ISSYS) announced today that it has been awarded $1.98 million from the National Institute of Standards and Technology's (NIST) Advanced Technology Program (ATP). The award is dedicated to developing wireless, batteryless, microfabricated pressure sensors that can be implanted in the body for direct and continuous monitoring of biologic fluid pressures.

The two specific targets of this project are sensors for patients affected by hydrocephalus and glaucoma. For more than one million Americans with hydrocephalus, "this project will mean better monitoring of cerebrospinal fluid pressure. In particular, it will alert these patients when their shunting systems fail, and allow them to get prompt medical treatment," said the project’s Principal Investigator, Dr. Collin Rich. By eliminating the uncertainty about shunt functionality, these sensors save patients from constant worry and eliminate over $1.5 billion annually in medical testing and treatment in the U.S. alone.

Prior to this project, the in-situ monitoring of fluid pressures in patients with hydrocephalus, glaucoma, chronic heart failure, valve failure, or urinary incontinence has been difficult, if not impossible, due to the large size and lack of biocompatibility of current sensors. "We intend to change that," said Dr. Rich. "We already make pressure sensors the size of a grain of rice, and we're taking those devices a few steps further. Our sensor will be a single, self-contained unit that does not need a battery, external catheter, leads, or antenna. Instead, the device will be powered and read by an external radiofrequency (RF) transceiver - a hand-held device capable of detecting the sensor's response from up to six inches away."

Once developed, the devices will be evaluated both in-vitro and in-vivo by teams at the University of Michigan's Kellogg Eye Center and The Cleveland Clinic Foundation for biocompatibility and clinical usefulness.

"We're very excited to have ATP's support," said Mr. Randall Grimes, the Director of Business Development. "Their involvement can take years off the development time and get this technology to those who need it as soon as possible. It also lets us tackle the question of MEMS (Microelectromechanical Systems) biocompatibility, potentially opening the door for a host of BioMEMS products."

Integrated Sensing Systems Inc. (ISSYS) is a leader in advanced micromachining technologies for semiconductor, industrial and medical applications. ISSYS produces these devices using its flexible manufacturing infrastructure established with assistance from Defense Advanced Project Research Agency (DARPA) MEMS Program. More information can be found at ISSYS' or NIST’s Web Sites at http://www.mems-issys.com/ or http://www.nist.gov/public_affairs/atp2000/00004324.htm.

National Institute of Standards and Technology (NIST) Single Company Advanced Technology Program
Implantable, Batteryless Microsensor with RF Telemetry for Chronic, Remote Monitoring of Biologic Pressures Duration: 3 years
November 2000 - November 2003

Project Abstract

The rapid growth of MEMS has fostered a whole host of new devices and technologies. MEMS is particularly well-suited to the fabrication of devices requiring the integration of precision mechanical and electrical components in a microscale package, such as is often required for biomedical devices.

This proposal aims to develop an innovative, wireless, monolithic, microfabricated pressure transducer for chronic, remote monitoring of biologic pressures. Pressure is read from the batteryless sensor by means of an external, handheld RF telemetry unit. The monolithic device design overcomes mechanical ruggedness and biocompatibility limitations of state-of-the-art hybrid systems reported elsewhere. The minimally-intrusive, grain-of-rice-sized package offers substantial flexibility in placement and orientation during implantation.

Targeted applications include direct monitoring of intracranial pressure for hydrocephalus patients and continuous monitoring of intraocular pressure for glaucoma therapy. As well, the device is suitable for remote monitoring of other biologic and non-biologic pressures.

Results gleaned from long-term biocompatibility testing of the device will also be useful for the development of other implantable, silicon-based microdevices.

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