FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs / Research and Development

Boston Scientific Kicks Off Trial of Next-Gen Acuity and Reliance ICD Leads

April 24, 2014
A A

Boston Scientific has completed the first implant in the Navigate X4 safety and efficacy trial, which is evaluating the company’s next generation Acuity X4 left-ventricular pacing leads and Reliance 4-front defibrillation leads.

The multicenter nonrandomized trial will enroll 1,541 and 2,290 adult patients with specific left-ventricular ejection fractions or atrial fibrillation criteria, the devicemaker said Tuesday.

Acuity patients will be measured for lead-related complication-free rates through six months post-implant and for pacing capture thresholds in the programmed configuration at three months post-implant. Reliance patients will be followed for lead-related complication-free rates from three through 24 months following surgery and pacing thresholds at 0.5 ms pulse width at three months.

Both devices are CE-marked, though they remain investigational in the U.S. Results of the Navigate X4 trial will be used to support FDA approval, the company said. — Lena Freund

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.