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.
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) approveddevicefor 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
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 43,000 employees working across eight hospitals, over 400 outpatient practices, nearly 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.
Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 7,300 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country’s best in several pediatric specialties.
For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter and YouTube.
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