Key result
New Pamira ICD lead shows similar or improved implantation handling versus its predecessor.
Why the study?
A new ICD lead with a polyurethane cover added for improved long-term reliance required post-market evaluation in patients undergoing de-novo ICD or CRT-D implantation.
Does the new Pamira ICD lead demonstrate acceptable handling and short-term performance in patients undergoing de-novo ICD or CRT-D implantation?
Observational
Does the new Pamira ICD lead demonstrate acceptable handling and short-term performance in patients undergoing de-novo ICD or CRT-D implantation?
The new Pamira ICD lead with a polyurethane cover shows acceptable handling and short-term performance, though long-term reliability data is still needed.
Answers are grounded in this paper and cite their sources.
Supports short-term use of the Pamira ICD lead; leaves open long-term reliability in prospective studies.
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.
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Bystriansky et al. (2025) conducted an observational in Patients undergoing de-novo ICD or CRT-D implantation. Pamira ICD lead vs. Predecessor without polyurethane cover was evaluated on Handling during implantation and short-term follow-up results. The new Pamira ICD lead demonstrated similar or improved handling during implantation compared to its predecessor without a polyurethane cover.
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