|Medtronic's Evera implantable defibrillator andProtecta cardiac resynchronization therapy-defibrillator are among the company's devices that have the SmartShock technology. --Courtesy of Medtronic|
Medtronic ($MDT) announced new study results published in HeartRhythm that support the Smart Shock Technology used in its cardiac resynchronization therapy and implantable cardioverter defibrillators to avoid delivering unnecessary shocks to the heart.
Results from the four-year PainFree SST study of 2,790 patients found that less than 4% of patients using SmartShock had had an inappropriate shock at two years postimplant. Medtronic says that in general, 20% of ICD patients experience an inappropriate shock, resulting in anxiety and unnecessary hospitalization or emergency room visits.
"The new results from PainFree SST reinforce that SmartShock technology streamlines programming to help deliver shocks only when necessary to save a life, and that ICD programming truly matters in improving patient outcomes," said Dr. Angelo Auricchio of Fondazione Cardiocentro Ticino in Lugano, Switzerland, in a statement.
:SmartShock Technology includes six Medtronic-exclusive algorithms that distinguish between life threatening and non-life threatening arrhythmias and electrical noise sensed by the device system in order to reduce inappropriate shocks," Medtronic said in a statement emailed to FierceMedicalDevices.
These include three solutions designed to discriminate between different non-lethal and lethal arrhythmias to provide lifesaving shock therapy when necessary, T-wave discrimination and lead noise discrimination, and lead integrity alert to provide advanced warning of potential lead fractures.
Another study of 4,131 patients followed from 2009 to 2012, called Shock-Less, demonstrates the importance of programing the devices properly, and not just using the default studies, Medtronic says in the release. Clinicians who received programming reports and recommendations were as much as 20% more likely to customize the ICD, which also lowers the risk of inappropriate shocks.
Medtronic said it has simplified the programming of its ICDs based on the study results.
"For decades, ICDs have proven effective in treating dangerous heart rhythms that lead to sudden cardiac death, and now new features and best-practice programming help physicians further reduce the rate of unnecessary shocks in their patients," said Dr. Marshall Stanton, the vice president and general manager Medtronic's tachycardia business, in a statement. "These innovations ensure that shocks are delivered only when needed to save lives, offering peace of mind for patients and physicians, and reducing costs to the healthcare system."
Editor's Note: This article has been updated with additional information from Medtronic.