Patient monitor for cardiopulmonary bypass cleared, launched
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LivaNova announced it received regulatory approvals and has initiated a targeted commercial launch if its patient-tailored monitoring system for use during cardiopulmonary bypass procedures.
The monitoring system (Essenz), which received clearance from the FDA and other regulatory bodies, provides the perfusionist with decision-making support during the entire cardiopulmonary bypass procedure and is compatible with the company’s heart-lung machine (LivaNova S5), according to a company press release.
“The Essenz Patient Monitor provides advanced and insightful data through one central screen and supports us in making data-driven decisions throughout a case,” Ed Overdevest, clinical perfusionist at Catharina Hospital in Eindhoven, The Netherlands, the site of the monitoring system’s commercial launch, said in the release. “With the monitor, we can individualize the patient management strategy using features such as the intra-operative quality indicator threshold and goal-directed perfusion modules. The combination of insightful data with an intuitive interface enabled our team to implement it for clinical use in the operating room almost immediately.”
According to the release, features of the monitoring system include:
- intraoperative quality indicator threshold and goal-directed perfusion modules to allow an individualized patient management strategy;
- a graphical user interface that continuously displays patient parameters;
- software architecture that complies with the latest standards of market requirements; and
- integration with operating room external devices and electronic medical record systems that complies with the latest cybersecurity requirements.
According to the release, the company’s full perfusion system is not available for sale and is currently in development.
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