Continuous blood monitor for use during cardiopulmonary bypass gains FDA 510(k) clearance

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Key takeaways:

• A continuous in-line blood monitor received 510(k) clearance from the FDA.
• The device is designed for continuous blood monitoring during cardiopulmonary bypass procedures.

LivaNova announced it received FDA 510(k) clearance and a CE mark for its in-line blood monitor which provides continuous monitoring during cardiopulmonary bypass procedures.

The blood monitor (Essenz) is integrated into the company’s next-generation perfusion system, which allows perfusionists to manage blood parameters directly from the system’s cockpit, without the need for additional monitors or holders, according to a company press release.

The blood monitor provides measured values specifically for oxygen saturation, hematocrit, partial pressure of oxygen and temperature, and is the only in-line blood monitoring system that operates within Clinical Laboratory Improvement Amendments guidelines, according to the release.

In addition, the device requires no calibration to set device measurements, saving users time during setup, according to the release.

“Dynamic conditions can rapidly change a patient’s blood parameters during a cardiopulmonary bypass procedure,” Marco Dolci, president of LivaNova Cardiopulmonary, said in the release. “The Essenz In-Line Blood Monitor provides continuous monitoring throughout a patient’s procedure. Access to accurate, real-time measurements directly from the Essenz Perfusion System allows for quick decisions and tailored care strategies to serve the patient.”