Boston Scientific (NYSE:BSX) said the 1st patient was implanted in a clinical trial of its Acuity X4 quadripolar left-ventricular pacing leads and Reliance 4-Front defibrillation leads, ahead of its bid for FDA approval for the devices.
The trial, dubbed Navigate X4, is slated to enroll between 1,542 and 2,290 patients at up to 125 centers in the United States, Canada and Israel, Boston Scientific said. The study calls for the Acuity X4 and Reliance 4-Front leads to be connected to the Natick, Mass.-based company’s X4 CRT-D devices, according to a press release.
“For the past 20 years, Boston Scientific has led the industry with regard to lead reliability and performance,” chief medical office for rhythm management Dr. Kenneth Stein said in prepared remarks. “The Acuity X4 and Reliance 4-Front leads are designed to continue this tradition and will provide physicians better options to improve patient care.”
Last week Boston Scientific announced FDA approval for its newest suite of cardiac devices, including its Dynagen Mini and Inogen Mini implantable cardioverter defibrillators and its Dynagen X4 and Inogen X4 quadripolar cardiac resynchronization therapy defibrillators.
The company won CE Mark approval in the European Union last December for its Autogen X4, Dynagen X4, and Inogen X4 cardiac resynchronization therapy defibrillators (CRT-Ds), plus CE Mark for a suite of Acuity X4 quadripolar LV leads and the Acuity Pro lead delivery system.