Biotronik today released long-term data from registry studies of its Linox and Linoxsmart implantable cardioverter defibrillator leads, touting the survival probabilities of over 95% at 4 and 5 years.
The company said its Galaxy and Celestial registry studies include data from a total of 3,933 Linox ICD leads implanted in 3,840 patients across 146 U.S. study centers.
“The results of this large scale, prospective analysis should provide assurance to both implanting physicians and their patients that the magnitude of scientific evidence shows these leads to be safe and reliable. Their ‘real-world’ performance and survival rates are similar to other well-performing leads reported in the literature,” lead author Dr. Eric Good said in a press release.
Data from the 2 studies indicates a survival probability of 96.3% with the Linox leads at 5 years and a 96.6% survival rate at 4 years with its Linoxsmart leads. Data from the studies was published in the Journal of Cardiovascular Electrophysiology.
“The scale and thoroughness of the Galaxy and Celestial registries demonstrate Biotronik’s deep commitment to evaluating our ICD leads’ long-term durability, a product of an intensive design process followed by extremely rigorous testing. As good is never enough for us, we constantly strive to further refine our products’ reliability, performance, and usability. Our philosophy has always been incremental improvement with a strong focus on durability and performance. That’s what our engineers in Germany, Switzerland, and the US are constantly working hard to achieve,” Biotronik senior veep Manuel Ortega said in prepared remarks.
Earlier this month, Biotronik won FDA premarket approval for its BioMonitor 2 magnetic resonance imaging-compatible insertable cardiac remote monitor.
The BioMonitor 2 device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said. The device uses Biotronik’s ProMRI technology and is approved for full-body MRI scans at 1.5 and 3 tesla strength.