Corventis completes enrollment for clinical trials of its MUSIC program

Sep 14 2009

Corventis, Inc., a developer of wireless cardiovascular solutions designed to enable early detection, prevention and treatment of cardiovascular conditions, announced today enrollment completion of the company’s MUSIC (Multi-Sensor Monitoring in Congestive Heart Failure) program consisting of 2 trials: the MUSIC Asia (180 patients) and the pivotal MUSIC study (362 patients). The MUSIC program – the goal of which is to develop and evaluate an algorithm to predict heart failure events – has enrolled a total of 542 patients in the international, multi-center prospective trials. Preliminary findings from the MUSIC Asia study were presented today at the 13^th Annual Scientific Meeting of the Heart Failure Society of America in Boston, Mass.

“Preventing acute heart failure events is a major challenge in cardiology today, but one that brings the potential to reduce hospitalizations and save lives,” said Inder Anand, MD, PhD, Director of the Heart Failure Program, Minneapolis VA Medical Center and Professor of Medicine, University of Minnesota, and MUSIC Asia Co-Principal Investigator. “As the first such investigation to employ an external, non-invasive, multi-sensor monitoring system with continuous collection capabilities, I am pleased with early results regarding the sensitivity and specificity of individual trends provided by the system. We look forward to exploring how the multi-sensor capabilities can further aid clinicians by providing advance warning of impending acute decompensation.”

The MUSIC program enrolled 542 heart failure patients in 32 centers across the United States and Asia. A non-invasive, multi-sensor adhesive device was applied to the patient’s chest and replaced weekly during the 90-day monitoring period.

The Corventis technology used in the study was a clinical prototype of the AVIVO^TM Mobile Patient Management System, a wireless system which collects heart rate, respiratory rate, fluid status, posture and activity data in patients away from the hospital. An unobtrusive, water-resistant device called PiiX™ is adhered to the patient’s skin to automatically collect and transmit physiological data. The patient carries a second device called zLink™ – similar in size and weight to a cell phone – which wirelessly sends the PiiX data to Corventis for analysis and display to healthcare professionals on a secure website at www.corventis.com.

“Corventis is committed to bringing technologically advanced and patient-friendly solutions to assist physicians in the management of heart failure patients across the globe,” said Corventis President and CEO, Ed Manicka, PhD. “The early results from MUSIC which show that a single noninvasive sensor can predict impending decompensation with a sensitivity of 89% is an exceptional first step. By incorporating the multi-sensor data collected in MUSIC to further augment the performance of our algorithms, our goal is to further enhance performance and thus bring a patient-friendly system that also delivers truly actionable information to clinicians treating patients with this complex condition.”

In the United States, more than five million Americans are suffering from heart failure, and each year more than one million patients are hospitalized with the condition. It is estimated that up to 50 percent of hospitalized heart failure patients will be readmitted within six months of discharge.