LivaNova (NSDQ:LIVN) announced today that it received FDA 510(k) clearance for its B-Capta system integrated into the S5 heart-lung machine.
London-based LivaNova’s B-Capta, a new, in-line, blood-gas monitoring system is to be integrated into the S5 HLM to easily and accurately monitor arterial and venous blood gas parameters even during long and complex pediatric and adult cardiopulmonary bypass procedures.
B-Capta received CE mark approval in Europe in May 2020 and completed a limited commercial release in Europe. It will now be available globally.
The system uses sensing technology to provide accurate and continuous measurements to allow the perfusionist to quickly react to parameter changes. Its interface reduces set-up time, aligns parameters to those of the hospital’s laboratory blood gas analyzer and includes accurate oxygen partial pressure measurements.
“B-Capta significantly extends the in-line, blood-gas monitoring options available to our customers for continuous monitoring of key patient physiological parameters consistent with clinical guidelines during extracorporeal life support procedures,” LivaNova SVP of global operations & R&D Marco Dolci said in the release. “Now integrated into our world-leading S5 HLM, the optical-based technology used for B-Capta provides accurate and reliable monitoring of patient blood gas parameters.”
LivaNova also received FDA 510(k) clearance for the S5 PRO HLM, which is an upgrade on the heart-lung machine and features B-Capta as a primary component alongside a new level sensor and improved software, plus a new alarm system.
“The launch of B-Capta reinforces our strategic direction, furthers our partnership with perfusionists and proves why we are the leaders in the extracorporeal circulation space,” LivaNova North America president Paul Buckman said. “B-Capta is a key enrichment to our S5 HLM platform, and the first of a number of new innovations our customers can expect from us.”
