Boston Scientific has implanted the first patient with a new version of its Ingevity pacing leads, designed for use in the magnetic resonance imaging (MRI) environment, in a clinical study.
The pacing leads, which are expected be paired with the company’s Ingenio family of pacemakers, treats bradycardia and provides key enhancements in maneuverability, reliability, fixation and electrical performance.
The multi-center, non-randomized, prospective INGEVITY trial will enroll one thousand patients and use the safety, performance and effectiveness data of the pacing leads for supporting the US Food and Drug Administration (FDA), CE mark and other regulatory approvals.
Boston Scientific cardiac rhythm management business senior vice president and chief medical officer 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.