Crawford Long Hospital in Atlanta on Thursday became the first medical facility in the nation to perform an implant of a promising new heart failure device approved just last week by the U.S. Food and Drug Administration. Dr. Angel Leon performed the procedure on a 62-year old Cartersville, Georgia woman, implanting the Medtronic InSyncÒ cardiac resynchronization therapy system in approximately one hour at the Carlyle Fraser Heart Center.

InSync cardiac resynchronization therapy (CRT), approved for market release by the FDA on Aug. 28, is considered the first major therapeutic breakthrough for heart failure patients since the development of specialized heart failure drugs. The treatment is designed for patients who have moderate to severe heart failure and signals a new era in device-based solutions for this condition.

“Cardiac resynchronization therapy will benefit many thousands of patients, offering them a treatment option they’ve never had before,” said Dr. Leon, Associate Professor of Internal Medicine at Crawford Long, which is a member of the Emory Health Care System. Dr. Leon was a key investigator during the clinical trial that evaluated the safety and effectiveness of the new therapy. “These patients are among the sickest in the healthcare system, but after this therapy they begin to feel better almost immediately. Many of them go from being virtually bedridden to leading normal lives,” added Dr. Leon.

Dr. Leon is considered an expert in cardiac resynchronization therapy and Crawford Long/Emory has been one of the nation’s top implant centers. Over the past three years, Dr. Leon and his associate, Dr. David DeLurgio, have enrolled more than 200 patients in cardiac resynchronization therapy studies.

Nearly 5 million Americans are afflicted with heart failure, a chronic and debilitating condition that often robs patients of their ability to live full, independent lives. Of these 5 million, it is estimated that more than 650,000 patients may be candidates for the Medtronic InSync system, which is the first implantable therapy to be approved by the FDA for this large and growing heart failure patient population.

Total heart failure costs in the U.S. are estimated at $38 billion annually and growing rapidly. Global costs range as high as $80 billion.

“The InSync cardiac resynchronization system has succeeded in restoring patient quality of life and functional capacity beyond our expectations,” said Dr. Williams Abraham, Professor of Medicine and Chief, Division of Cardiovascular Medicine at the University of Kentucky College of Medicine. Dr. Abraham was the lead clinical investigator for the clinical study that evaluated InSync. “Heart failure is the most costly cardiovascular illness in America and one that increases in incidence and prevalence each year.”

The Medtronic InSync cardiac resynchronization system includes a small pulse generator (about the size of two stacked silver dollars) that is implanted beneath the skin in the shoulder region. Through insulated wires called leads, the system delivers synchronized electrical stimulation to three chambers of the heart, enabling them to pump blood more efficiently throughout the body. The result is a dramatic improvement in exercise capacity, quality of life and functional status, allowing those who previously had limited ability to perform common tasks to resume a more normal daily routine.