Abstract
INTRODUCTION: A new implantable cardioverter-defibrillator (ICD) lead with a polyurethane cover added for improved long-term reliance was investigated in a post-market study. METHODS: The prospective BIO|MASTER Pamira study is designed to evaluate the new Pamira ICD lead in patients undergoing de-novo ICD or cardiac resynchronization therapy (CRT-D) implantation. We report first data from implantation and 6-month follow-up. RESULTS: Despite its slightly larger diameter, the lead demonstrated similar or improved handling during implantation compared to its predecessor without polyurethane cover. CONCLUSION: All results from implantation and short-term follow-up aligned with expectations. To show an improved reliance, long-term data will be required.