Boston Scientific enrols first patient in multisensor CRT clinical trial
12 July 2010
Boston Scientific Corporation (NYSE: BSX) has enrolled the first patient in its MultiSENSE clinical trial. The trial is designed to evaluate multiple physiologic sensors in the Company's Cognis cardiac resynchronization therapy defibrillators (CRT-Ds).
Boston Scientific plans to use the trial data to help develop a clinical alert that identifies the early onset of worsening heart failure.
When combined with the Company's Latitude Patient Management System, CRT-D sensors would be able to monitor a patient outside of a clinical setting and permit the Latitude system to deliver early notification to the physician when the patient's heart failure worsens.
"Heart failure is a complex disease and physicians use a number of diagnostics to assess a patient's condition and disease progression," said John Boehmer, M.D., Medical Director, Heart Failure Program and Professor of Medicine, Penn State Hershey Medical Center and Principal Investigator of the MultiSENSE trial. "A multi-sensor design in an implantable device, with the predictive power of multiple data points, would enable physicians to take clinical action sooner to avoid hospitalization due to heart failure."
"The MultiSENSE trial marks a significant step toward addressing the unmet needs of heart failure patients," said Kenneth Stein, M.D., Chief Medical Officer, CRM, for Boston Scientific's Cardiology, Rhythm and Vascular Group. "Boston Scientific's unique multi-sensor approach is designed to allow our CRT-Ds to assess the same symptoms and data a doctor evaluates when seeing a heart failure patient in the office."
Heart failure is a debilitating condition that affects a patient's quality of life and life expectancy. It is a condition in which the heart weakens and gradually loses the ability to pump blood effectively. Approximately 22 million people worldwide suffer from heart failure and nearly one million new cases are diagnosed annually, making it the most rapidly growing cardiovascular disorder.