The Mount Sinai Hospital First in the World to Offer Patients New FDA Approved Device for Severely Calcified Arteries

The Cardiac Catheterization Lab at The Mount Sinai Hospital launches United States' use of Diamondback 360® Coronary Orbital Atherectomy System to reduce severe arterial calcium prior to cardiac stents.

New York, NY – October 28, 2013 / Press Release / —

Leading interventional cardiologists at The Mount Sinai Hospital are the first in the world to use a newly U.S. Food and Drug Administration (FDA) approved device for the treatment of severely calcified coronary arteries before the placement of a cardiac stent to open a blocked artery.

The new device being used in the Cardiac Catheterization Laboratory at The Mount Sinai Hospital is called the Diamondback 360® Coronary Orbital Atherectomy System. It's spinning electrically powered 1.25 mm diamond-coated crown is located on a thin cardiac catheterization guide wire and works within seconds to reduce the amount of hard calcium buildup in a coronary artery. The small calcium particles sanded from the artery's wall are then naturally discarded from the heart and the body.

The atherectomy system made by Cardiovascular Systems, Inc. was just FDA approved on Oct. 21. It is the first new coronary atherectomy system in more than two decades.

"We are excited that we are the first in the world to offer this innovation to our patients," says Samin K. Sharma, MD, Director of Clinical and Interventional Cardiology at The Mount Sinai Hospital and the Zena and Michael A. Wiener Professor of Medicine at Icahn School of Medicine at Mount Sinai. "This newly approved technology will allow us to significantly reduce our patients' heart blockage percentage for more successful cardiac stent placement. Also, we hope its use will facilitate improved outcomes for these patients with severely calcified blockages who are traditionally more challenging to treat."

Approximately 25 percent of patients with coronary artery disease in need of a percutaneous coronary intervention (PCI) to treat a heart blockage have severe levels of arterial calcium lining their arteries. However, until now there have been limited treatment options to remove it. Increased arterial calcium can lead PCI patients to experience an increased risk of poor outcomes, major adverse cardiac events (MACE), or increased mortality.

"Previous clinical trial results (ORBIT II) testing the Diamondback system have shown it to be safe and effective in treating severely calcified lesions. Also, trial results showed most patients to be free from MACE following the procedure," says Dr. Sharma. "We look forward to offering greater safety to this complex patient population at Mount Sinai."

Dr. Sharma is the national Principal Investigator of the MACE study for the newly FDA approved device which will prospectively evaluate the economic outcomes of treating varying degrees of calcified blockages in the coronary arteries.

About the Mount Sinai Health System
The Mount Sinai Health System is an integrated health system committed to providing distinguished care, conducting transformative research, and advancing biomedical education. Structured around seven member hospital campuses and a single medical school, the Health System has an extensive ambulatory network and a range of inpatient and outpatient services—from community-based facilities to tertiary and quaternary care.

The System includes approximately 6,600 primary and specialty care physicians, 12-minority-owned free-standing ambulatory surgery centers, over 45 ambulatory practices throughout the five boroughs of New York City, Westchester, and Long Island, as well as 31 affiliated community health centers. Physicians are affiliated with the Icahn School of Medicine at Mount Sinai, which is ranked among the top 20 medical schools both in National Institutes of Health funding and by U.S. News & World Report.

For more information, visit http://www.mountsinai.org/.
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