FDA approves Medtronic's Protecta implantable defibrillators

Medtronic, Inc. (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval of the Protecta™ portfolio of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds). The new family of implantable defibrillators features SmartShock™ Technology, which includes six new Medtronic-exclusive algorithms that recognize life-threatening arrhythmias and deliver therapeutic shocks only when appropriate, therefore enhancing patient quality of life. Findings from the Virtual ICD study, based on a statistical model, shows that 98 percent of patients with SmartShock Technology will be free of inappropriate shocks one year after implant and 92 percent will be free of inappropriate shocks five years after implant. Shipments of the Protecta portfolio of products will begin immediately.

"With recent studies showing that up to one in five patients may experience inappropriate shocks, this new technology can significantly mitigate that concern and will have a real-world impact on my patients' lives by improving quality of life," said Kent Volosin, M.D., cardiologist at the University of Pennsylvania in Philadelphia.

Implantable defibrillators are designed to provide lifesaving shocks or painless pacing to stop life-threatening fast or irregular heart beats, also known as ventricular arrhythmias, which can lead to sudden cardiac death. Sudden cardiac death kills more people each year than lung cancer, breast cancer and HIV/AIDS combined. Medtronic estimates more than 70,000 lives have been saved worldwide by implantable defibrillators over the past five years.

While the majority of shocks delivered are necessary to treat potentially fatal arrhythmias, studies estimate that up to 20 percent of patients with implantable defibrillators may experience inappropriate shocks in response to a benign arrhythmia or electrical noise sensed by the device. Additionally, data show that 61 percent of patients who received an inappropriate shock visited the hospital, clinic or emergency room at least once within three days of receiving therapy.

"The Protecta family of devices addresses one of physicians' top needs—allowing them to better serve patients by providing devices that are designed to deliver a shock only when needed to save a life," said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. "This new innovation is the latest example of Medtronic's 20-year leadership in shock reduction technology through product innovation backed by industry-leading clinical research."

Medtronic has supported eight major shock reduction clinical trials (Shock-Less, PREPARE, PainFree Rx I and II, PainFree SST, WAVE, ADVANCE III and EMPIRIC). In total, these trials included more than 5,500 patients worldwide—more than any other device manufacturer.