A Medical Device Daily
Medtronic (Minneapolis) reported the start of a nationwide trial to examine the relationship between the company's OptiVol Fluid Status Monitoring technology and the ability to predict worsening heart failure. The trial will assess whether more frequent (monthly vs. quarterly) review of patient data results in earlier clinical intervention.
OptiVol fluid status monitoring uses low-level electrical pulses that travel across the thoracic cavity (the chest area encompassing the lungs and heart) to measure the level of resistance, indicating fluid in the chest – a common sign of heart failure.
Since normal fluid levels vary from patient to patient, and fluid accumulation can be either slow or rapid, OptiVol's ability to measure fluid status trends over time in conjunction with other key device trends and physiologic measures available in Medtronic's Cardiac Compass Reports can provide the opportunity to intervene before patient symptoms develop.
"Medtronic has been the pioneer in the development of tools to aid in the early detection of worsening heart failure," said Marshall Stanton, MD, VP of clinical research for the company's Cardiac Rhythm Disease Management business. "The goal of this new trial, called OptiVol Care Pathway, is to provide physicians with clinical evidence to understand the role and application of comprehensive diagnostics, including fluid status monitoring, in managing heart failure patients."