Boston Scientific Corp. is touting a pair of studies it says indicate that implantable cardiac rhythm management devices perform better in the real world than they were predicted to in human clinical trials.
The studies, both of which were sponsored by the Natick-based devices leviathan, examined the real-world performance of its implantable cardioverter and cardiac resynchronization therapy defibrillators. The results were presented in Boston at a Heart Rhythm Society conference.
The first study analyzed data from the eight-year Madit II clinical study of implanted ICDs, comparing outcomes in heart attack patients with moderate impairment of the left ventricle with outcomes from drug therapy alone.
BSC said the results showed that a life is saved for every six patients implanted with the device, over the eight-year span of the trial. It also showed a 41 percent relative reduction in the risk of death at four years and a 37 percent reduction in the risk of death after eight years.
The trial Initial clinical trial results showed that ICDs reduced the relative risk of death by 31 percent after 20 months.
The second study, of data from BoSci’s Altitude Clinical Science program, analyzed data from the company’s Latitude patient management system. It’s tracked more than 130,000 patients since its 2006 inception, monitoring their implanted devices to detect clinical events between doctor’s visits and sending the data directly to physicians.
The Altitude study looked at data from nearly 86,000 of those patients, finding five-year survival rates for patients implanted with ICDs of up to 92 percent and of up to 78 percent for patients with CRTDs.
Company officials said those results exceed the survival rates from previous, randomized clinical trials, but did not quantify those prior results.
