News | December 10, 2013

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

Cardiac Catheterization Lab launches Diamondback 360 for use in United States

diamondback 360 mount sinai cath lab atherectomy
December 10, 2013 — Interventional cardiologists at 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 device being used in the Cardiac Catheterization Laboratory at Mount Sinai Hospital is Cardiovascular Systems Inc.’s Diamondback 360 Coronary Orbital Atherectomy System. It’s spinning electrically powered 1.25 mm diamond-coated crown is located on a thin cardiac catheterization guidewire 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.
 
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,” said Samin Sharma, M.D., director of clinical and interventional cardiology, Mount Sinai Hospital, and the Zena and Michael A. Wiener Professor of Medicine, 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 (CAD) 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,” said Sharma. “Also, trial results showed most patients to be free from MACE following the procedure.”
 
Sharma is the national principal investigator of the MACE study for the newly FDA approved device. The study will prospectively evaluate the economic outcomes of treating varying degrees of calcified blockages in the coronary arteries.
 
For more information: www.mountsinai.org, www.csi360.com

Related Content

Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
CMS considers eliminating cardiac bundled payments.
Feature | Business| August 16, 2017 | Dave Fornell
August 16, 2017 — The Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to reduce the number
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Four Blue Cross Blue Shield Companies Issue Positive Medical Policies on HeartFlow FFRct Analysis
News | FFR Catheters| August 09, 2017
HeartFlow Inc. announced that four Blue Cross Blue Shield companies have each issued a positive medical policy for the...
Ra Medical Systems Granted Broad Patent for DABRA Catheter
News | Peripheral Artery Disease (PAD)| August 09, 2017
August 9, 2017 — Ra Medical Systems announced that the United States Patent and Trademark Office (USPTO) has granted
Roxwood Medical Announces Agreement With Abbott for U.S. Product Distribution
News | Catheters| August 09, 2017
Roxwood Medical Inc. recently announced it has entered into an exclusive agreement with Abbott for distribution of...
New Jersey Researcher Exploring New Stem Cell Therapies for Heart Attacks
News | Stem Cell Therapies| August 04, 2017
In petri dishes in her campus laboratory at New Jersey Institute of Technology, Alice Lee is developing colonies of...
Abbott Initiates XIENCE Short DAPT Clinical Trial
News | Antiplatelet and Anticoagulation Therapies| August 03, 2017
Abbott recently announced the first patient has been enrolled in a clinical study evaluating the short-term use of...
Overlay Init