Long‐Term Evaluation of Biotronik Linox and Linox^smart Implantable Cardioverter Defibrillator Leads

Abstract

Linox and Linox(smart) ICD leads are safe, reliable and infrequently associated with lead-related AEs. Additionally, estimated cumulative survival probability is clinically acceptable and well within industry standards. Ongoing data collection will confirm the longer-term safety and performance of the Linox family of ICD leads.

Long‐Term Stability and Clinical Utility of Amplified Atrial Electrograms in a Single‐Lead ICD System with Floating Atrial Electrodes

“…Linox S/SD leads are no longer commercially available and have been replaced over recent years with the Linox smart models that have additional silicone‐based outer coating, Silglide®, designed to improve gliding characteristics and reduce friction within the introducer and between the leads. A recent analysis of data from large prospective postmarket registries, GALAXY and CELESTIAL, involving 3,933 Linox family ICD leads implanted in 3,840 patients at 146 U.S. centers, did not confirm the above concerns . In this analysis, based upon prospectively defined and independently adjudicated lead‐related adverse events, both Linox and Linox smart models showed clinically acceptable performance with survival estimates of 96.3% at 5 years (Linox) and 96.6% at 4 years (Linox smart) .…”

“…A recent analysis of data from large prospective postmarket registries, GALAXY and CELESTIAL, involving 3,933 Linox family ICD leads implanted in 3,840 patients at 146 U.S. centers, did not confirm the above concerns. 21 In this analysis, based upon prospectively defined and independently adjudicated lead-related adverse events, both Linox and Linox smart models showed clinically acceptable performance with survival estimates of 96.3% at 5 years (Linox) and 96.6% at 4 years (Linox smart) . However, the incidence of functionally silent conductor externalization remains unknown.…”

Analysis of early failure of Biotronik Linox Smart implantable cardioverter‐defibrillator leads: A comparative study of three defibrillator leads

“…Of note are the excellent survival rates of the Linox S and SD leads (97% and 97.8% at 5 years, respectively), described in Biotronik's product performance report in January 2016 and of the Linox Smart SD lead, published in January 2017, with survival rates of 98.3% at 5 years. Likewise, the results of the Biotronik Galaxy and Celestial registries, with a mean follow‐up of 2.3 years for Linox Smart leads, report a lead failure rate of 2.2% at 3 years, which underestimates the true performance of these leads in terms of the development of oversensing, which mostly develops from the third year onward (Figure ).…”

Performance of the Linox implantable cardioverter defibrillator leads: A single‐center experience

“…Most of the studies investigated the survival of the Linox model. Good and colleagues reported similar estimated cumulative survival probability rates for both Linox models. In our cohort, the follow up of Linox model (63.7 ± 24.1 months) was significantly longer than Linox Smart model (31.8 ± 14.7 months), and the survival probability of Linox model ICD was not different compared to Linox Smart model during 63 months follow up.…”

“…Several studies reported that the Linox ICD leads are safe. Good and colleagues reported 96.3% survival probability at 5 years, a clinically acceptable rate. Conversely, many others showed early failure of the Linox ICD leads.…”