WINTHROP INTERVENTIONAL CARDIOLOGISTS FIRST ON LONG ISLAND TO IMPLANT NEW DRUG-ELUTING STENTS RECENTLY APPROVED BY THE FDA
Mineola, NY – Just three days after the U.S. Food and Drug Administration approved the first in a new generation of drug-eluting stents for use in patients with narrowed coronary arteries, doctors at Winthrop-University Hospital in Mineola became the first interventional cardiologists on Long Island to implant the new device. # # #
On Monday, February 4, Dr. Jin Park performed the angioplasty procedure on Christopolos Bougiamis, a 68-year-old man from Syosset, NY. Minutes later, in another one of Winthrop’s four highly sophisticated interventional cardiology labs, interventional cardiologist Richard Schwartz, MD, performed the second such procedure and an hour later, Dr. Michael Sassower implanted the third.
The new device – the “Endeavor” Zotarolimus-eluting Coronary Stent manufactured by Medtronic, Inc. – is the first drug-eluting stent approved since 2004 and the first since FDA convened its Circulatory System Devices Panel in 2006 to discuss evidence of the rare risk of blood clots occurring in patients who receive drug-eluting stents. Medtronic’s application to the FDA was supported by seven clinical trials involving 4,100 patients over a period of four years.
“The Medtronic Endeavor stent appears to represent a true step forward in technology,” said Srihari S. Naidu, MD, Director of the Cardiac Catheterization Laboratory at Winthrop. “It has been designed to address two issues that were observed in the first generation of drug-eluting stents. The new stent employs a drug that is as effective as the earlier drugs in reducing restenosis, but which is embedded in a more biocompatible coating. This combination has demonstrated a very low rate of clotting, similar to that seen when no drug-coating is used at all. In addition, the Endeavor stent is stronger, thinner and more maneuverable, which is helpful when we have to deliver one to the areas of the heart that were previously difficult to access .”
Like other coronary stents, Endeavor is a tiny metal mesh tube, which is crimped around a balloon and delivered to the narrowed section of the coronary artery via a long thin catheter during a procedure known as an angioplasty. Unlike other stents, however, the Endeavor stent is coated with a small amount of a new drug, zotarolimus, which was developed exclusively for use on a stent. Release of zotarolimus over time prevents restenosis, a re-narrowing of the artery when new tissue begins to form.
“This important approval is the result of a substantial amount of clinical evidence and a careful review by both FDA and its advisory committee,” said Daniel Schultz, M.D., Director of FDA's Center for Devices and Radiological Health.
The introduction of the latest improvements in coronary care is a hallmark of Winthrop’s highly respected Institute for Heart Care, which provides comprehensive cardiac services including the most advanced levels of diagnostic technology, medical management, interventional cardiology and cardiac surgery. Winthrop’s Interventional Cardiology Program and its Thoracic & Cardiovascular Surgery Program are both recognized state-wide for their excellent outcomes.
For more information about heart care at Winthrop, please call 1-866-WINTHROP.