Blood gas monitoring system for use during CABG nets FDA clearance
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LivaNova announced it received FDA 510(k) clearance for its system for monitoring arterial and venous blood gas parameters during pediatric and adult CABG procedures.
The system (B-Capta), which is integrated into LivaNova’s heart-lung machine (S5), previously received a CE Mark in May 2020.
According to a company press release, the monitoring system provides continuous blood gas measurements and allows for clinicians to quickly react to parameter changes. The system aligns parameters to those of the hospital’s laboratory blood gas analyzer and includes oxygen partial pressure.
The device does not require calibration at the beginning of the procedure and has visual and audible indicators for when parameters fall outside of thresholds which are set by the user, the company stated in the release.
“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,” Marco Dolci, senior vice president of LivaNova, said in the release.
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