Clinical Trials In Brief
This article was originally published in The Gray Sheet
Executive Summary
Remote monitoring study: Medtronic announces Dec. 11 the launch of its 2,000-patient randomized, prospective CONNECT trial. The "Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision" trial will be conducted at 150 centers in the U.S. to evaluate the degree to which Medtronic's CareLink network interacts with its Concerto cardiac resynchronization therapy devices and Virtuoso implantable cardioverter defibrillators to improve patient care and reduce healthcare costs. The firm hopes the trial will show that CareLink, an internet-based remote patient monitoring system introduced in 2002, enables earlier decisions to address arrhythmias, heart disease progression and other issues compared with patients who receive only in-office care, thereby shifting treatment away from more expensive acute interventions. According to Medtronic, about 95,000 patients at more than 1,000 clinics in the U.S. already use CareLink. Sales of the remotely monitored ICDs drove a 6% sequential increase in Medtronic's ICD market share during its second fiscal quarter (ended Oct. 31) (1"The Gray Sheet" Nov. 27, 2006, p. 5)...