Medical Device Daily

In the future, ECG monitoring may be available to those heart patients requiring continuous monitoring in the form of a comfortable vest. Such a system wouldn’t require those pesky sticky electrodes taped to your chest, which can require shaving hair, or result in the skin irritation produced by typical Holter monitors.

Pamela Bunes, president/CEO of Signalife (Greenville, South Carolina), told Medical Device Daily that the company hopes to submit an application to the FDA within a month seeking clearance for such a product, a cardiac vest, described as looking somewhat like a sports bra.

“Given the nature of this product, the turnaround [time] is not extensive,” Bunes said, noting that the vest falls into the Class II device category.

The cardiac vest, which has been featured in a late 2006 NBC “Today Show” segment, has been “extensively” used in testing in the Champ Car World Series open cockpit racing, the company notes. During those tests, the ECG signals allowed physicians to evaluate data previously unavailable when captured in the very harsh environment of a race car.

Signalife said this is in contrast to current cardiac devices, where noise and artifact “distort ECG recordings in an ambulatory setting.”

The Signalife vest features electrodes about the size of a quarter embedded in a cloth fabric designed to provide an improved level of comfort.

Signalife was formed in 2003 under the name Recom Managed Systems and then changed its name to Signalife in November 2005 (Medical Device Daily, Nov. 11, 2005).

Its flagship technology was developed by Budimir Drakulic, Signalife’s chief technology officer in the early 1990s at the University of California Los Angeles (UCLA).

However, it was not until mid-2004 when the first lab prototype was completed. That was followed in late 2004 by the first units completed by the Battelle Memorial Institute (Columbus, Ohio), which “did all of the testing” for Signalife, Bunes said.

The company already has secured FDA clearance of its core product, the Fidelity 100, which uses 12 leads and 10 electrodes and offers ambulatory or resting ECG with what the company called a “clear amplified signal” and enables wireless transmission of data from a device worn on the body to a laptop computer.

But Bunes emphasized that Signalife is not a “one-product” company. She said its product is already FDA-cleared and the others in its pipeline range from the “very complex” to the “relatively simple.”

The Fidelity 100 technology is the basic system used in the cardiac vest being readied for FDA submission, as well as an over-the-counter product in the pipeline which will ultimately be planned for sale in pharmacies and big-name retailers.

The Fidelity 100 technology has been evaluated at Duke University (Durham, North Carolina) with data analyzed by the eECG Core Laboratory at the Duke Clinical Research Institute in the Device Implementation, Validation and Application (DIVA) Program for the company’s initial product, the Fidelity 100 Ambulatory EKG/ECG monitor. A total of 108 patients, with clinical indications for elective or possible percutaneous coronary intervention were recorded to provide “detailed documentation” of the device’s ability to detect and quantify transient ischemic episodes in comparison to conventional ECG devices (MDD, Feb. 7, 2006).

Bune said that although the results of the study were discussed this year at the American Heart Association (AHA; Dallas) Scientific Sessions in Chicago, Signalife is not detailing them prior to a paper expected to be published by a researcher.

For the cardiac vest’s use in the test with race drivers, Drakulic had the assistance of physicians from the Cleveland Clinic (Cleveland) as well as Champ Car Medical Chris Pinderski, Champ Car medical director, for more than a year. For the drivers, the vest is worn under their suits while they race at speeds of more than 200 miles per hour.

Bunes said of the use of Signalife’s technology with the Champ Car Program, “We were thrilled to have been selected for this study and look forward to future opportunities to apply our technology in the ambulatory heart monitoring industry.”

In addition to racing drivers, athletes from a variety of sports have offered their support for Signalife’s products.

But while its ambulatory devices may be useful to athletes and race drivers alike, Bunes told MDD that the “thing that is more compelling is you have a patient population,” that is large and well-defined and that these products address a large part of the $400 billion cardiac disease market.

Another company, VivoMetrics (Ventura, California) also has developed a vest, called the LifeShirt, which is designed to monitor for a variety of respiratory and cardiopulmonary functions, as opposed to purely cardiovascular data.

The LifeShirt has been used to study subjects as varied as soldiers on the battlefield to young children and parents who were affected by the 9/11 terror attacks, that study initiated in September 2005 (MDD, Sept. 13, 2005).

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