Corventis Announces FDA Clearance And US Launch Of The NUVANT™ Mobile Cardiac Telemetry System

Main Category: Cardiovascular / Cardiology
Also Included In: Heart Disease;  Medical Devices / Diagnostics
Article Date: 21 Jan 2010 - 1:00 PDT

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Corventis, Inc., a developer of wireless cardiovascular solutions, announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its NUVANT™ Mobile Cardiac Telemetry (MCT) System for the detection of non-lethal arrhythmias. In addition, the company announced that its Monitoring Center has been approved by the Center for Medicare & Medicaid Services (CMS) as an Independent Diagnostic Testing Facility (IDTF). Corventis has 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.

"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, who is the founder of the annual Body Computing Conference and a pioneer in the field of networked medical devices. "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 NUVANT MCT System leverages the low profile form factor, advanced algorithms and multi-sensor capabilities of the PiiX™ wearable platform to enable 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, email and/or the secure http://www.corventis.com website. 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."

Cardiac arrhythmias, or irregular heart rhythms, can cause chest pain and fainting, and may lead to sudden cardiac death or stroke. According to the American Heart Association, 835,000 Americans are discharged from hospital care with cardiac arrhythmia diagnoses each year.1 More than 2.2 million Americans experience atrial fibrillation each year, a type of cardiac arrhythmia that is associated with an increased risk for stroke.

"I am extremely pleased with momentum our organization continues to build in the field of wireless healthcare," said Ed Manicka, Ph.D., President and CEO of Corventis. "This marks another successful milestone in our company's history and is a testament to the capabilities of our organization and the versatility of our technology platform. At Corventis, we are committed to rapid innovation and we look forward to bringing this outstanding arrhythmia detection solution to clinicians in the United States."

About the NUVANT Mobile Cardiac Telemetry System

Electrocardiograms (ECGs) and other tests performed in a hospital or clinic setting provide valuable information about the rhythm of the heart and overall patient health status. In many cases, however, it is necessary to monitor heart rhythm or other physiological signals for a longer period of time to better understand a patient's condition.

The NUVANT MCT System allows up to 30 days of continuous monitoring for ambulatory patients - providing clinicians with insight into a patient's cardiovascular health during normal daily routines. Multiple sensors and advanced algorithms on the wearable PiiX enable intelligent detection of cardiac arrhythmias. ECG collection may also be triggered on-demand when a patient experiences cardiac symptoms. Clinical information such as ECG and heart rate are then wirelessly transmitted via a small handheld device, zLink™, to Corventis. After review by the Corventis Monitoring Center, the relevant arrhythmias are promptly provided to the prescribing physician for further analysis.

Source
Corventis, Inc

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