GALAXY Registry

Long-term Evaluation of the Linox Family ICD Leads Registry

Study Design

  • 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, but enrollment is complete.

Key Result

Recent publication1 with results from the ongoing GALAXY and CELESTIAL studies demonstrate favorable lead survival probabilities


Clinical Relevance

  • Linox and Linoxsmart ICD leads are safe, reliable and infrequently associated with lead-related 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.
Reference no.
  • NCT00836589
1° endpoints
  • To evaluate the overall incidence of serious adverse events related to the Linox family of ICD leads
  • To evaluate the incidence of each type of serious adverse event that contributes to the above point
2° endpoints
  • Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-enrollment
  • Electrical characteristics of each individual Linox lead system, measured at scheduled GALAXY registry follow ups through 5 years post-enrollment
Clinical Sites
  • 98 centers, 75 active
Sample Size
  • 1,999 patients
Inclusion Criteria
  • Successfully implanted Linox lead system connected to a BIOTRONIK ICD, from 1-45 days prior to enrollment
  • Able to understand the nature of the registry and provide informed consent
  • Available for follow-up visits on a regular basis at the investigational site
  • Age greater than or equal to 18 years
  • Presence of another life-threatening, underlying illness separate from their cardiac disorder
  • Pregnancy
Main Exclusion Criteria
  • Enrolled in any IDE clinical study
  • Planned cardiac surgical procedures or investigational measures within the next 6 months
  • Expected to receive a heart transplant within 1 year
  • Life expectancy less than 1 year
  • Linox and Linoxsmart ICD lead systems in conjunction with a BIOTRONIK ICD
  • At least once every 6 months per site's institutional standard of care.
Study Duration
  • From January 2009 to November 2016

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Related Products


The CELESTIAL study, a multi-center, prospective FDA reviewed designed to monitor the real world performance of BIOTRONIK leads.

ICD Teaser

ICD 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