The Natick, Mass.-based medical device company said a patient in Sweden was the first enrollee in the trial, which is aimed at proving the safety and effectiveness of the devices in treating slow heartbeats or bradycardia.
The new leads are likely to be paired with Boston Scientific’s Ingenio pacemaker line, according to a press release. The company is hoping the data from the 1,000-patient trial will back regulatory nods in the U.S. and the European Union, according to the release.
"Our research and development efforts focus on consistency, repeatability and industry-leading reliability," CMO Dr. Kenneth Stein said in prepared remarks. "We believe Ingevity reflects all of these design principles, with the goal of improving the quality of patient care across the globe."
Boston Scientific also said it’s planning another trial to evaluate the Ingevity/Ingenio duo in MRI settings, "to support FDA regulatory approval for this system combination," saying it plans to seek regulatory approvals in other markets too. The Ingenio/Fineline lead combination has already won CE Mark approval across the pond.
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