Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar Post Approval Registry
- Multi-center, prospective, non-randomized, FDA reviewed, observational study1
- Designed to gather long-term safety and reliability data on BIOTRONIK’s Corox BP LV leads
- 2,499 patients at 97 USA centers - This study is ongoing
The CELESTIAL registry focuses primarily on the performance of Corox leads (n=2,499), however, the majority of patients received a CRT-D system including a Linox or Linoxsmart ICD lead (n=1,843)
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 favorable 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|
BIOTRONIK offers high performance with safety in mind in the field of lead technology.
The GALAXY study, a multi-center, prospective FDA reviewed designed to monitor the real world performance of BIOTRONIK leads.
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