Medical Device Daily National Editor

Distance monitoring of the heart is one of the fast-growth sectors of the medical device cardiac arena – at least technologically but not always economically, due to reimbursement barriers.

These systems come essentially in two flavors, home-based and ambulatory, the latter usually via Holter devices. Home-based systems comes in two sub-flavors: requiring the patient to be at home near a box or phone or other device infrastructure; or allowing movement outside the home but somehow tethered electronically to the home-based box and hardware.

eCardio Diagnostics (The Woodlands, Texas) has reported the rollout of its newest product, eVolution, a single-component cardiac monitoring system providing data concerning the heart's rhythms, automatically, on an ambulatory basis and with no need for patient activation or other compliance.

eVolution is designed to provide the advantages of both the home-based and ambulatory systems, according to the company or, conversely, avoid the disadvantages of both, thus indicating a clear advance in this technology and the basis for the name.

Rachael Moore, director of marketing and communications for eCArdio, told Medical Device Daily that eCardio provides "the whole gamut, from Holter monitoring to this daily extended device."

She said that Holter monitoring "has been around for the last 50 years," but the company has now is able to move beyond this traditional modality "to the new eVolution."

The specific advantages are that the system offers the long-term, continuous assessment provided by home-based monitors but with a single small device and enabling the type of patient mobility usually related to Holter systems, but even more flexible and patient-friendly.

Moore noted that the eVolution provides this monitoring automatically, requiring no patient compliance such as pressing a button or other action to send a data message. At the same time, the patient can send a message, if necessary, indicating some problem, with the push of a button or over a phone line.

The automated transference of data from an ambulatory patient and circumventing patient action is the system's main selling point to physicians, said Robert Jordan, executive vice president of the company.

The system, Jordan told MDD, essentially works as "a first set of eyes" to track the patient's heart function, whether indicating normal operation or signaling a problem and the need for some intervention.

eVolution records and transmits cardiac rhythm events to eCardio's 24-hour monitoring center in Houston, and with what the company calls "an exclusive auto-detecting algorithm" and micro-processor, the device provides real-time data analysis via digital rather than traditional analog technology.

Jordan explained that the waveform data is then translated by a certified cardiographic technician to create a physician report which is transmitted daily to a secure website which the physician can access from any PC.

In case of receiving a transmission indicating abnormal activity, an internet "action report" transmission is then followed by a phone call to the doctor, alerting him to check the website, with both technician report and waveform, to determine if intervention is required.

Jordan reports that the company currently receives 75,000 transmissions per month at its data center, though he declined offering the number of patents this represents.

He said that after a "soft launch" of the system over the net 30 days he expects the eVolution to provide about 24% of all transmissions to the company's data center.

Moore emphasized the eVolution as being a user-friendlier two-lead device vs. the standard Holter, which has six leads and requires being worn continuously for at least a two-day period and not taken off.

By comparison, eVolution the device itself about the size of a Blackberry, Jordan said can be easily removed for greater flexibility (bathing or getting dressed, for instance) and is usually worn for much longer period to collect more comprehensive data.

"Data over the last 10 years has shown," Moore said, "that critical arrhythmias aren't going to show up on a Holter if you just have it on for two days."

The eVolution can be worn up to 30 days, thus able to capture critical abnormalities, but is generally worn about 20 days, she said.

A final, frequently defining, advantage for the eVolution: The system is so designed that it falls under, and will be reimbursed, under standard ambulatory reimbursement codes.

eCardio said it will offer demonstrations of the eVolution at the annual scientific sessions of the American Heart Association (Dallas), Nov. 9-11 in New Orleans.

Earlier this year, eCardio launched what it called "an extended monitoring" device, the eTriggerPLUS, in conjunction with an extended monitoring service, and its first-generation of this type of device.

The company said that the eTriggerPLUS is a single component device that features eTimer automatic data capture which expands its flexibility for use in various patient therapies or clinical study applications, such as device monitoring, post-ablation follow-up, drug titration and the documentation of abnormal cardiac function.