Cardiologists with Asheville Cardiology Associates, an affiliate of Mission Health, are leading the way in the number of cases performed in a national clinical trial of a novel netcovered stent used in patents who have just experienced an ST Elevation Myocardial Infarction (STEMI), better known as a heart attack. More than half of the U.S. total cases performed in the trial thus far have taken place at Mission Hospital.
The first U.S. stent implantation of the trial was performed at Mission Hospital on Dec. 6, 2013. To date, eight surgeries implanting the device, the MGuardTM Prime Embolic Protection Stent (EPS) with MicroNetTM covering, have taken place at Mission. The devices are manufactured by InspireMD, which has U.S. operations headquartered in Boston, Mass.
Stents such as this one are small metal mesh devices that are placed within an artery to open a blocked section so that blood flow throughout the cardiovascular system can continue unimpeded. The FDA trial, known as MASTER II (MGuard for Acute ST Elevation Reperfusion), is the second in a series of randomized clinical studies intended to validate that the device is safe and effective, and can then be approved by the FDA for widespread use in patients in the United States.
The concern with placing stents in the arteries of patients either during or in the throes of a STEMI event is that insertion of the metal stent will dislodge pieces of plaque or a clot from within a clogged artery. That loose piece of material can then cause further damage within the cardiovascular system, and in some cases can worsen the heart damage. Standard stents were not engineered for heart attack patients; those devices were designed for patients who are in a more stable condition than a person experiencing a heart attack. The MGuard Prime MicroNet covering acts like a net when the metal stent is implanted, capturing loose matter and preventing it from traveling.
The principal investigator of the trial is Jan Matti Pattanayak, M.D., of Asheville Cardiology Associates. “We’ve successfully enrolled seven patients who have a 50:50 chance of getting an MGuard stent, or our usual stent,” said Dr. Pattanayak. “We continue to see these patients a month after their event, and will follow up with them after a year’s time. Clinical trials allow doctors access to cutting-edge medical devices that hopefully will improve patient care in the future.”
A clinical trial is a limited study of a medical device in a select group of carefully monitored patients to determine the safety and efficacy of the device prior to U.S. Food and Drug Administration approval. This study will involve 1,114 patients at up to 35 institutions across the country. The device is already approved for use in Europe.
Mission Health participates in numerous clinical trials in a wide variety of medical specialties. Each trial protocol is carefully reviewed and progress is monitored, ensuring patients access to innovative medical devices and procedures close to home.