London-based LivaNova PLC announces that it has received U.S. FDA 510(k) clearance for B-Capta, the in-line, blood-gas monitoring system integrated into the S5 heart-lung machine (HLM).
The system is designed to monitor arterial and venous blood gas parameters even during long and complex pediatric and adult cardiopulmonary bypass procedures. B-Capta, which received CE Mark in May 2020 and completed a successful limited commercial release in Europe, will now be available globally.
B-Capta’s sensing technology provides accurate and continuous measurements that allow the perfusionist to quickly react to parameter changes. The system’s user interface reduces set-up time, aligning parameters to those of the hospital’s laboratory blood gas analyzer and includes accurate oxygen partial pressure, a key measurement when performing goal-directed perfusion.
“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,” says Marco Dolci, LivaNova senior vice president, global operations and research and design. “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.”
Other advantages of B-Capta include:
- A “ready-to-go” set-up, meaning the device does not require calibration at the beginning of the procedure, which is especially beneficial during emergency cases.
- Visual and audible indicators for when parameters fall outside of thresholds selected by the user.
- Integration into the S5 HLM, eliminating the need for additional external monitors and providing an unobstructed view for the perfusionist. Plus, all patient and procedure parameters remain in the same location, which improves the overall workflow and reduces stress levels felt by perfusionists during procedures.
- Arterial and venous sensors that fit all disposable cuvette sizes, allowing the perfusionist to use the same sensor for both adult and pediatric procedures.
“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,” says Paul Buckman, LivaNova president, North America. “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.”
LivaNova also received 510(k) clearance for its S5 PROHLM, an upgrade of the heart-lung machine that features B-Capta as a primary component, along with a new level sensor and improved software with a new alarm system.