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Devices Cardiology Radiology FDA

 News Release - March 10, 2016

Revolutionary 3D Cardiac Mapping System Developed by Aurora Health Care Physician Receives FDA Clearance

MILWAUKEE, WI--(Healthcare Sales & Marketing Network) - Dr. Jasbir Sra, an internationally recognized cardiac electrophysiologist with Aurora Health Care, has received clearance from the Food and Drug Administration (FDA) to market a new three-dimensional cardiac mapping system that could transform the treatment of heart rhythm abnormalities such as atrial fibrillation, or AFib.

The new system, called Navik 3D, is the first cardiac mapping system that does not require specialized equipment. It instead uses existing patient monitoring and fluoroscopic imaging systems in hospital labs to identify catheter locations in the heart and create 3D maps of the cardiac chamber of interest.

This new cost effective and simplistic technology will allow physicians throughout the world to more easily, accurately, and confidently complete their procedures by pinpointing the exact location in the heart's chambers that are experiencing the arrhythmias. More than five million Americans suffer from heart arrhythmias, with AFib being the most common.

Dr. Sra and his team of scientists and engineers have been developing the system since 2012 with ongoing testing and product development at both Aurora St. Luke's Medical Center and the Aurora Research Institute.

For Aurora Health Care and the Aurora Research Institute, the new technology builds on the organization's commitment to innovation.

"Aurora Health Care and the Aurora Research Institute are proud to support the work of Dr. Sra and his talented team in the development of this leading-edge technology that will ultimately better treat patients with heart irregularities," said Randall Lambrecht, Ph.D., president of the Aurora Research Institute. "Dr. Sra is a pioneer in his understanding of heart arrhythmias and we were thrilled to see the FDA clearance of Navik 3D."

Dr. Sra is a renowned author of more than 100 original manuscripts and more than 70 editorials and reviews on complex heart arrhythmias issues. His work has been published in the New England Journal of Medicine, Journal of American College of Cardiology, and in Circulation, the Journal of the American Heart Association. He is also Editor of the book "Practical Electrophysiology". He is a fellow of the American College of Cardiology, American Heart Association, and the Heart Rhythm Society and is the medical director of the Clinical and Research Electrophysiology Laboratories at Aurora St. Luke's Medical Center and Aurora Sinai Medical Center in Milwaukee.

The new Navik 3D Mapping system is another in the heart and vascular milestones for Aurora Health Care, including:

  • The largest and most experienced Transcatheter Aortic Valve Replacement (TAVR) program in Wisconsin, performing more than 700 cases with a 100 percent implementation rate.
  • The first health care system in world to use new 4D cardiovascular ultrasound technology from GE Healthcare, helping to see the heart like never before.
  • The first health care system in Wisconsin to implant a minimally-invasive leadless pacemaker, offering faster recovery time for patients.
  • The first heart transplant in Wisconsin in 1968, and since 1982, more than 800 total transplants, more than any other health care system in the state.
  • A leader in Ventricular Assistant Devices (VAD)s installation in patients with Advanced Heart Failure, having installed more than 700 VADs in the past four years.
  • The first atrial defibrillator implant in the U.S., the first catheter ablation in Wisconsin and the first Epicardial Catheter Ablation of AFib in America.
  • The first device implant in Wisconsin to prevent strokes in patients with atrial fibrillation.

Aurora Health Care's world-renowned heart and vascular team consists of specialists who use state-of-the-art tools and technologies to provide early diagnosis and advanced cardiac care, including surgical and non-surgical treatment options, as well as hybrid heart procedures.

About Aurora Health Care

Aurora Health Care is a not-for-profit Wisconsin-area health care provider and a national leader in efforts to improve health care quality. Aurora offers services at sites in more than 90 communities throughout eastern Wisconsin and northern Illinois. Aurora is Wisconsin's most comprehensive health care provider and the state's largest private employer. Aurora serves more than 1.2 million patients every year via a comprehensive network of facilities, services and providers, including 15 hospitals, 159 clinics, 70 pharmacies and 30,000 amazing Caregivers. As evidenced by more than 400 active clinical trials, Aurora is dedicated to delivering innovations to provide the best possible care today, and to define the best care for tomorrow. Get helpful health and wellness information via the Aurora MyHealth blog, our Facebook page, our Twitter account and our Pinterest account.

Source: Aurora Health Care

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