Two major healthcare providers align to develop a consensus on recent Class I implantable cardioverter-defibrillator (ICD) recall
MINNEAPOLIS--(BUSINESS WIRE)-- Cardiovascular leaders will gather in Minneapolis for a one-day summit on Jan. 20, to review data for Riata and Riata ST implantable cardioverter-defibrillator (ICD) leads, which recently underwent a Class I FDA recall. Physicians from the Minneapolis Heart Institute Foundation and Mayo Clinic have organized the summit to develop a consensus regarding the management of patients who have these leads.
Approximately 80,000 active patients have Riata or Riata ST ICD leads in the U.S. These leads, manufactured by St. Jude, have exhibited externalized cables whereby the cables appear outside the lead body on fluoroscopy. Leads with externalized cables may be functioning normally and electrically intact, or there may be signs of malfunction. Therefore, it is not clear how patients with these leads should be managed, which is why the physicians organized the one-day summit.
The summit directors are Robert G. Hauser, MD, senior cardiologist at the Minneapolis Heart Institute® at Abbott Northwestern Hospital, and David L. Hayes, MD, professor of medicine at Mayo Clinic in Rochester, Minn. Both Dr. Hauser and Dr. Hayes are past presidents of the Heart Rhythm Society.
“This Class FDA recall will impact many patients throughout the United States, as well as the caregivers tasked with ensuring the best possible treatment for those patients,” said Dr. Hauser. “Cardiac electrophysiologists, along with their fellow physicians and allied health personnel who take care of patients that have had Riata ICD leads should attend this summit.”
The consensus on patient management strategies will seek to include follow-up and approaches to leads that have failed and require replacement. Similar ICD lead issues have occurred with other manufacturers and remain an ongoing challenge of the ICD industry.
“We are looking to gather together numerous U.S. and international caregivers to thoroughly review the data and form a unified opinion how to proceed with these patients,” Dr. Hauser said. “If you’re responsible for the care of these patients, then you should attend this summit.”
Time & Place
- Time: Friday, Jan. 20, 2012, 8:00 a.m.–4:30 p.m. (CST)
- Place: Minneapolis Airport Marriott (near the Mall of America)
2020 American Blvd. E, Bloomington, MN
For more information or to register, visit http://riata.eventbrite.com.
Minneapolis Heart Institute Foundation
The Minneapolis Heart Institute Foundation (MHIF) is dedicated to creating a world without heart disease through groundbreaking clinical research and innovative education programs. MHIF’s mission is to promote and improve cardiovascular health, quality of life and longevity for all.
Minneapolis Heart Institute®
The Minneapolis Heart Institute® is recognized internationally as one of the world’s leading providers of heart and vascular care. This state-of-the-art facility combines the finest in personalized patient care with sophisticated technology in a unique, family-oriented environment. The Institute’s programs, a number of which are conducted in conjunction with Abbott Northwestern Hospital, address the full range of heart and vascular health needs: prevention, diagnosis, treatment and rehabilitation.
Allina Hospitals & Clinics
The Minneapolis Heart Institute and Abbott Northwestern Hospital are part of Allina Hospitals & Clinics, a non-profit network of healthcare providers based in Minneapolis that serves St. Paul and the Twin Cities area, New Ulm, River Falls and other communities throughout Minnesota and western Wisconsin. More information can be found at allina.com.
Allina Hospitals & Clinics
Gloria O'Connell, 612-863-4801
KEYWORDS: United States North America Minnesota
INDUSTRY KEYWORDS: Health Biotechnology Cardiology Hospitals Medical Devices