LivaNova Receives FDA 510(k) Clearance for B-Capta, the New In-Line, Blood-Gas Monitoring System Integrated Into the S5 Heart-Lung Machine
Intuitive, optical-based technology system now available around the world
B-Capta’s innovative sensing technology provides accurate and continuous measurements that allow the perfusionist to quickly react to parameter changes. The system’s intuitive user interface reduces set-up time, aligning parameters to those of the hospital’s Laboratory Blood Gas Analyzer (ABL) and includes accurate oxygen partial pressure (pO2), a key measurement when performing Goal-Directed Perfusion (GDP).
“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,” said
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,” said
Safe Harbor Statement
This news release contains “forward-looking statements” concerning our goals, beliefs, expectations, strategies, objectives, plans and underlying assumptions and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding B-Capta. Actual results may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of our Annual Report on Form 10-K for the year ended
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