Long-term Evaluation of the Linox Family ICD Leads Registry
- Multi-center , prospective, non-randomized, FDA reviewed, observational study
- Designed to confirm long-term safety and reliability of BIOTRONIK’s Linox ICD leads
- 1,997 patients at 98 USA centers - This study is ongoing
Recent publication1 with results from the ongoing GALAXY and CELESTIAL studies demonstrate favorable lead survival probabilities
- Linox and Linoxsmart ICD leads are safe, reliable and infrequently associated with lead-related adverse events (AEs)
- Estimated cumulative survival probability is favourable and well within industry standards
- Scientifically sound analysis due to multi-center, high enrollment, prospective study design as well as adjudication of AEs by an independent panel of five EPs
- Most extensive description of performance, safety and longevity of Linox ICD leads published to date
|Main Exclusion Criteria|
The CELESTIAL study, a multi-center, prospective FDA reviewed designed to monitor the real world performance of BIOTRONIK leads.
BIOTRONIK offers high performance with safety in mind in the field of lead technology.
1 Good ED, Cakulev I, Orlov MV, Hirsh D, Similes J, Mohr K, Moll P, Bloom H; Long-Term Evaluation of Biotronik Linox and Linoxsmart Implantable Cardioverter Defibrillator Leads; J Cardiovasc Electrophysiol 2016 [epub]; DOI: 10.1111/jce.12971