A Medical Device Daily

The Department of Homeland Security’s Office for Domestic Preparedness has awarded a grant for “Physio-logic Assessment of Wildland Firefighters During Their Annual Pack Test” to Storm King Mountain Technologies (Camarillo, California) and VivoMetrics Government Services (Ventura, California).

The two companies will partner to gather and study high-resolution physiologic data on 500 wildland firefighters during their annual “pack test.” This is a test to determine fitness of wildland firefighters in which they wear a 45-pound pack and must walk 3.5 miles in 45 minutes or less. This year three firefighters died during a pack test in Montana.

The study will gather high-resolution physiologic data and traditional paramedic data gathered via VivoMetrics’ LifeShirt system in order to describe the physiologic res-ponse to the strenuous physical test given wildland firefighters.

The physiologic data will be used to establish guidelines for monitoring wildland firefighters during pack tests, training scenarios and deployment. The entire project must be completed in 12 months.

The primary objectives are to measure respiration, ECG, SpO2, body temperature, posture and activity as experienced by wildland firefighters over the course of a pack test; develop a greater understanding of the time course and scale of physiologic responses to the stress associated with a pack test; and develop guidelines for monitoring the physiological responses of wildland firefighters to help increase the likelihood of safely completing future pack tests, training scenarios and deployment.

The total grant amount is $748,699.

Jim Roth is president of Storm King Mountain Tech-nologies. Ten years ago, his brother, a wildland firefighter, and 12 others were tragically killed fighting a fire on Storm King Mountain in Colorado. Roth subsequently started his company of the same name, dedicated to improving safety for firefighters.

Noting that firefighters die every year during the pack test exercise, Storm King Mountain Technologies and VivoMetrics said the grant represents an opportunity for them to contribute to improving safety for such firefighters.

Codman & Shurtleff (Raynham, Massachusetts), a Johnson & Johnson (New Brunswick, New Jersey) company, said it has signed a development and licensing agreement with privately held Cranium Telemetrics (Hannover, Germany) and a supply agreement with Fraunhofer IMS (Duisberg, Germany), an independent “applied research” facility, for an implantable sensor chip that wirelessly monitors intracranial pressure (ICP). Terms of the transaction were not disclosed.

Codman will integrate the sensor technology into its shunt system for hydrocephalus, the Codman Hakim Programmable Valve System.

“This enhancement will help clinicians get information about their patient’s condition without having to do an invasive procedure,” said Glen Kashuba, Codman president. “This new programmable shunt system with integrated sensor will be the most technologically advanced product for managing hydrocephalus in the world.”

Currently, if a patient becomes symptomatic after a shunt is implanted, to get continuous ICP information, an invasive procedure must be performed to implant a sensor into the brain, where it can only remain for a limited time.

A second surgery is then performed to remove it, and the patient is hospitalized for the entire time.

Codman’s new system is intended to eliminate the need for additional surgeries and hospitalization.

In other grants/contracts news:

• etrials Worldwide (Morrisville, North Carolina) reported that Omnicare Clinical Research, a subsidiary of Omnicare (Covington, New York) and provider of drug development services to pharmaceutical, biotechnology and medical device companies, has signed a multi-year, subscription licensing agreement that will enable its clients to utilize etrials’ eClinical platform for collecting, monitoring and analyzing clinical trial data.

Omnicare will develop and tailor studies for its clients to improve patient enrollment, provide access to cleaner data faster and shorten study timelines.

etrials’ technologies will help meet the eClinical needs of Omnicare’s clients who conduct clinical trials of all sizes and complexities in a wide variety of therapeutic areas.

The companies already have begun work on two studies utilizing the eClinical suite of products.

• Wyndgate Technologies (Denver), a division of Global Med Technologies, has signed an agreement with Suncoast Communities Blood Bank (SCBB; Sarasota, Florida) to provide its SafeTrace Tx advanced transfusion management system. Terms were not disclosed. SCBB also recently purchased SafeTrace, Wyndgate’s donor management solution.

Mark Magenheim, CEO and medical director of Suncoast Communities Blood Bank, said, “Wyndgate has successfully developed software to manage the complexities of our transfusion service business. We were presented with the options and advantages of SafeTrace Tx after receiving notification that our current solution was being ‘sunsetted.’ We selected SafeTrace Tx for its comprehensive safety features, application capabilities, and central transfusion service.”