FDA Clears Mobile Cardiac Telemetry System
January 20, 2010 – The FDA granted 510(k) market clearance for the NUVANT Mobile Cardiac Telemetry (MCT) System for the detection of nonlethal arrhythmias.
“The NUVANT MCT System represents the next generation of noninvasive, ambulatory arrhythmia monitoring,” said Leslie Saxon, M.D., chief, division of cardiology, Keck School of Medicine at the University of Southern California, Los Angeles. “By incorporating comprehensive algorithms and patient-activation functionality into the inconspicuous PiiX, NUVANT provides outstanding arrhythmia detection capabilities so physicians can more effectively identify even challenging suspected rhythm disturbances for diagnosis and treatment. Thus far, I have not seen a wireless cardiovascular system that works this well both for physicians and for patients.”
The NUVANT Mobile Cardiac Telemetry System is the second product launched from the Corventis portfolio of wireless cardiovascular solutions. Designed with a specific focus on ambulatory arrhythmia monitoring, the system has a low profile form factor, advanced algorithms and multisensor capabilities of the PiiX wearable platform. This enables continuous monitoring for a broad set of arrhythmias, including atrial fibrillation, as well as patient falls that may be associated with arrhythmias. Patients can also trigger the collection of an electrocardiogram (ECG), on-demand, upon experiencing symptoms, further aiding in the correlation of symptoms with the ECG.
All ECGs are promptly transmitted to the Corventis Monitoring Center via the wireless-enabled zLink, for review and response by trained cardiographic technicians. Physicians receive prompt notification of urgent events as well as actionable information in the form of episode reports, daily reports and end of use reports via fax, e-mail and/or the secure Web site. Using this information, a physician can diagnose symptomatic and asymptomatic cardiac arrhythmias and proactively manage patients remotely from anywhere across the globe.
“The ease of use of the NUVANT MCT System should encourage patient compliance for ambulatory arrhythmia monitoring,” said Maninder S. Bedi, M.D., director of cardiac electrophysiology at key centers in Pennsylvania and Ohio including Washington Hospital, Sharon Regional Health System, Steubenville Hospital and Wheeling Hospital. “The self-contained PiiX reduces the need for lead-wire management and when combined with automatic detection and wireless transmission capabilities, allows my patients to go about their daily routines without disruption.”
In addition to the FDA clearance, Corventis Inc. said its monitoring center has been approved by the Center for Medicare and Medicaid Services (CMS) as an independent diagnostic testing facility (IDTF). Corventis also received approval to bill for services provided to patients with Medicare and several commercial insurers, paving the way for the NUVANT MCT System to be available across the United States.
For more information: www.corventis.com