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

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

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