Proteus Biomedical (Redwood City, California) certainly is not the only company looking at how to improve the measurement of cardiac performance in heart failure patients. But according to Andrew Thompson, CEO and co-founder, "everybody else" has come up with a new lead and/or a new procedure.

"We don't want to invent a new therapy," Thompson told Medical Device Daily. Proteus is more interested in using its cardiac electronic tomography (CET) and multi-sensor lead system to make existing therapies safer, more effective and higher-value, he said.

CET is an operator-independent modality developed by Proteus. The first product application, in the field of heart failure, is intended to improve outcomes by "objectively assessing the relative hemodynamic effect of lead placement sites during and after CRT device implantation, and by quantitatively tracking a range of standard cardiac synchrony and performance measures over time," the company said.

The technology is designed to be fully integrated into any existing cardiac rhythm management system, and used without requiring additional complex pressure sensors or invasive procedures, Proteus said. The technique works by tracking the three-dimensional displacement of cardiac regions using standard CRT systems that have been modified to incorporate Proteus sensing technology and software. The procedure takes a few minutes and can be performed on patients at rest or on a treadmill, the company said.

A CRT device implantation procedure runs upwards of $60,000 – about $30,000 for the device and roughly another $30,000 for the procedure – "and it doesn't work about half the time," Thompson said. "That's a problem."

On Thursday Proteus reported the start of its Resynchronization using Electric Tomography to Improve Myocardial Efficiency (RETIME) 2.0 study, designed to assess the performance of its CET technology in heart failure patients undergoing implantation of a CRT device.

The point of the study, Thompson said, is "to show that the technology that we've now tested very extensively in animals and a previous feasibility study in humans does what we say it does."

According to Proteus, data from pre-clinical studies and from its RETIME 1.0 study demonstrated that CET quantifies important aspects of cardiac performance using an automated, operator-independent technique that yields results comparable to Tissue Doppler Imaging. The company said the RETIME 2.0 study will evaluate the system's ability to provide "immediate, actionable physiologic feedback" to determine optimal pacing sites in individual patients by correlating CET data with left ventricular pressure catheter readings, the current gold standard for measuring hemodynamic performance.

The three-site study will enroll from 30 to 50 patients and should be finished by the end of the year, Thompson said. Participating sites include Ohio State University (Columbus), with William Abraham, MD, and Ayesha Hasan, MD, serving as co-investigators; the University of Southern California (Los Angeles), with Ray Matthews, MD, and Michael Cao, MD, as co-investigators; and Cardiocentro Ticino (Lugano, Switzerland), with Angelo Auricchio, MD, as investigator.

"Advances in technology are expanding the clinical utility of implanted networked devices to a much broader range of heart failure patients," said Abraham, a professor of internal medicine and director of the division of cardiovascular medicine at Ohio State. "Cardiac electric tomography offers potential value in improving the efficacy of CRT as well as polypharmacy by providing objective, longitudinal measures of cardiac performance such as contractility, synchrony, and output."

By integrating in-body computer, sensor and communications technologies into existing device and drug therapies Thompson said Proteus is "pioneering" a space the company terms intelligent medicine.

He compared the technology to the computer in a car that runs every aspect of the vehicle yet is completely invisible to the driver to describe how the company can build sensors and computers into existing devices and connect to a mobile computing platform for patients and their physicians can monitor how well their heart is working.

According to Proteus, heart failure afflicts 5 million Americans and more than 30 million people worldwide, and is the single largest expense for hospitalizations in the U.S., costing $30 billion a year.