July 12, CARDIODYNAMICS INTERNATIONAL CORP. (San Diego, CA) announced Wednesday it has submitted a 510(k) application to the FDA in an effort to market a remote monitoring system that enables cardiac data from kidney patients on dialysis to be transmitted to physicians' offices.

The BioZdTEL uses CardioDynamics' proprietary BioZ noninvasive impedance cardiography (ICG) technology to ollect hemodynamic measurements, including cardiac output, stroke volume, systemic vascular resistance and fluid status. That information then is transmitted to physicians via the Internet.

If cleared by the FDA, CardioDynamics plans to utilize the BioZdTEL exclusively in its DiTEC (Diagnostic, treatment and Education of Cardiac Disease) program that links kidney disease specialists with cardiologists.

"The DiTEC clinical program is designed to directly assist nephrologists by enhancing cardiac evaluation and disease management activity of the patient in the dialysis setting, thereby augmenting the overall cardiac care provided by the treating nephrologists, slowing cardiovascular disease progression and preventing urgent trips to the hospital for preventable cardiac events, such as congestive heart failure and intra-dialytic hypotension," Dr. John Strobeck, president of HEART-LUNG ASSOCIATES OF AMERICA (HLAA; Hawthorne, NJ), said in a statement issued by CardioDynamics.

In March CardioDynamics entered into an alliance with HLAA, in which CardioDynamics would provide its BioZ cardiography technology to dialysis centers that utilize the cardiology, diagnostic and disease management services of HLAA.

The alliance stemmed from concern among heart and kidney specialists that hypertension and heart failure are inadequately treated in dialysis patients. The American Heart Association and the National Kidney Foundation estimate that cardiovascular events account for half of dialysis patients' deaths, according to CardioDynamics. Traditionally, nephrologists have focused on the complexity of their patients' kidney disease and dialysis treatment and have not been able to adequately address the opportunities to prevent and intervene in cardiovascular complications, the company said.

Under the CardioDynamics-HLAA agreement, end-stage kidney disease patients who are at high risk for cardiac events are monitored with the BioZ impedance cardiography technology during each dialysis treatment, the companies said in the earlier report.

The BioZdTEL device would facilitate transmission of the patient data obtained through that monitoring, CardioDynamics said.

"The BioZdTEL development is an important step in the company's information technology strategy of linking physicians to physicians and patients to physicians, via the Internet, Michael K. Perry, CardioDynamics CEO, said in a statement.

"We believe the Internet and wireless technologies will be important drivers to facilitate change within healthcare, and we plan on being on the forefront of this emerging $25 billion Internet healthcare market. We are committed to the development of Internet-based ICG devices and discussion are in progress with leading medical monitoring companies for inclusion of our proprietary technology into their product offerings," he said.

According to CardioDynamics, more than one million patients worldwide suffer chronic kidney failure, which, if treated properly, requires dialysis treatments up to three times a week.

Shares of CardioDynamics trade on Nasdaq under the symbol CDIC.

CardioDynamics International Corp. is a medical technology and information solutions company. Its BioZ system noninvasively provides medical professionals with hemodynamic data.