Boston Scientific has implanted the first patient with a new version of its pacing leads in a multi-centre, non-randomised prospective clinical study.
The Ingevity pacing leads, which are expected to be paired with the company’s Ingenio family of pacemakers, are designed for treating bradycardia.
The procedure, conducted at Karolinska University Hospital, also provides key enhancements in maneuverability, reliability, fixation and electrical performance.
The trial, named Ingevity, will enrol 1,000 patients and use the safety, performance and effectiveness data of the pacing leads to support regulatory approval applications to the US Food and Drug Administration (FDA), CE Mark and others.
Boston Scientific cardiac rhythm management business senior vice president and chief medical officer Dr Kenneth Stein said; "Our research and development efforts focus on consistency, repeatability and industry-leading reliability."
Karolinska University Hospital Pacing and ICD director, cardiology head and associate professor Fredrik Gadler said; "I felt very in control while maneuvering the lead, which allowed me to place the lead precisely where I intended."
In addition, the company is planning to commence a separate clinical study to evaluate Ingevity leads paired with Ingenio pacemakers for use in an MRI setting, in the first half of 2013.
Ingevity pacing leads are investigational devices and are not available for sale.
Image: Boston Scientific’s corporate headquarters in Natick, Massachusetts, US. Photo: Courtesy of BostonScientific.