LivaNova Receives U.S. FDA 510(k) Clearance for Essenz Heart-Lung Machine for Cardiopulmonary Bypass Procedures
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“The Essenz Perfusion System has tremendous potential to become a key addition to our clinical practice, fusing a new era of technology with the skill and expertise of the perfusionist,” said
Essenz is based on 50 years of trusted partnership with perfusionists.
Key attributes of the Essenz Perfusion System include:
Safe and Reliable:
The system is built on the proven LivaNova S5™ HLM, which has supported millions of patients for safe CPB procedures. Each pump on Essenz is controlled individually for simple, straightforward operations. HLM sensor checks confirm readiness before the CPB procedure starts. The Essenz HLM cockpit and Essenz Patient Monitor are connected but operate separately to further ensure reliability.
Patient-Tailored Care:
Accurate sensing technology and an intuitive dashboard on the Essenz Patient Monitor provide critical data to support individualized, data-driven patient care during a case. Essenz Patient Monitor utilizes official formulas to support perfusionists in the implementation of goal-directed perfusion (GDP), a therapy effective in reducing the risk of acute kidney injury.1 Mast-mounted pumps allow the user to optimize the position of the disposables (i.e., oxygenator and perfusion tubing set), which minimizes priming volumes and reduces hemodilution.
Intuitive:
The Essenz Patient Monitor offers an intuitive user interface and continuously records and displays data and events together to assist the perfusionist throughout a procedure. Data is automatically and seamlessly transferred, minimizing manual data entry and freeing up valuable time for the perfusionist in the OR. The technology platform is built to accommodate a stream of future software features and functionalities, making it a valuable long-term investment.
Flexible and Efficient:
The Essenz Perfusion System can be adapted to the individual needs of patients (adult and pediatric), workflows and users. It features an ergonomic design, including advanced cable management and a mast-mounted design that minimizes distractions and keeps the area clean and hygienic. The innovative cockpit provides one central view to control the device and check all perfusion and patient parameters. Also, Essenz has seamless integration with OR external devices and hospital information systems.
In addition, the Essenz Perfusion System is backed by a responsive service team of dedicated, local engineers in more than 100 countries, along with a global support center to address any needs.
“A perfusion system acts as a patient’s heart and lungs during an open-heart procedure, so having the highest-quality system backed by the expertise of a skilled perfusionist is paramount,” said
Learn more about the entire Essenz Perfusion System on the
*Note: The Essenz Heart-Lung Machine is not available for sale in all geographies. Visit the
References
- Goal-Directed Perfusion to reduce Acute Kidney Injury: A Randomized Trial Ranucci M. et al.
J Thorac Cardiovasc Surg. 2018 Nov; 156(5): 1918-1927.e2. doi.org/10.1016/j.jtcvs.2018.04.045
About
Safe Harbor Statement
This news release contains “forward-looking statements” concerning the Company’s 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 the Essenz Perfusion System, Essenz HLM and the Essenz Patient Monitor. Actual events 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 the Company’s most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.
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