Terumo Cardiovascular Announces 510(K) Clearance for the CDI OneView™ Monitoring System

Rhea-AI Summary

Terumo Cardiovascular announced that the U.S. FDA has granted 510(k) clearance for its CDI OneView Monitoring System. This next-generation platform can measure and display up to 22 key patient parameters during cardiopulmonary bypass surgery, enhancing perfusion safety and patient outcomes. Key new parameters include measured flow (Q), cardiac index (CI), and regional cerebral oxygen saturation (rSO2). The system's modular design allows for flexible configuration to meet clinical needs. Terumo emphasized the system's development was influenced by extensive feedback from global cardiovascular experts and is aimed at reducing complications such as acute kidney injury.

Positive

• FDA 510(k) clearance for CDI OneView, enhancing market confidence.
• Displays up to 22 vital patient parameters, improving clinical decision-making.
• Flexible and modular design caters to various clinical needs.
• New parameters like cardiac index and cerebral oxygen saturation can enhance patient care.
• System influenced by feedback from top cardiovascular institutions, ensuring relevance and effectiveness.
• Aims to reduce acute kidney injury incidence, a significant clinical benefit.

Negative

• No immediate financial impact or revenue projections provided.
• Risk of adoption delays as hospitals integrate the new technology.
• Potential for high implementation costs for healthcare providers.

All-new modular, expandable design displays up to 22 vital patient parameters with real-time convenience

ANN ARBOR, Mich., May 28, 2024 /PRNewswire/ -- Terumo Cardiovascular, a global leader in cardiovascular surgery technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CDI OneView Monitoring System. The next-generation CDI Systems platform provides visibility of key patient parameters during cardiopulmonary bypass surgery, critical to perfusion safety and improving patient outcomes.

The new CDI OneView System measures or displays up to 22 key parameters, the newest of which are measured flow (Q), cardiac index (CI), regional cerebral oxygen saturation (rSO₂), oxygen extraction ratio (O₂ER), Area Under the DO₂ Curve (AUC), and measured arterial oxygen saturation (SaO₂).  

This innovative system offers maximum configurability and flexibility in how the parameters can be viewed and prioritized to best suit clinical needs and preferences, while continuing to provide the critical information on which clinicians have come to rely.

"The world's leading cardiac centers have trusted CDI Systems for over 30 years. With the launch of the new CDI OneView System, Terumo Cardiovascular continues to bring value and enhanced patient care to healthcare providers and critically ill cardiac patients," said Robert DeRyke, President and CEO of Terumo Cardiovascular.  "The CDI OneView System technology is the latest extension of Terumo's commitment to delivering data-focused solutions to the perfusion community."  

New features and functions of Terumo's latest patient parameter monitoring system were influenced by extensive perfusionist input from leading global cardiovascular institutions. In response to the growing needs of healthcare providers, the new CDI OneView System now provides real-time O₂ER, CI, VO₂ and DO₂ information to help perfusionists maintain a safe threshold for those parameters. Independently published and reviewed clinical research indicates that maintaining optimal levels during cardiopulmonary bypass can help to reduce the incidence of acute kidney injury.^{1, 2}

About Terumo Cardiovascular

Terumo Cardiovascular manufactures and markets medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass and intra-operative monitoring. The company is headquartered in Ann Arbor, Michigan, with manufacturing operations in the U.S., Asia, and Latin America. It is one of several subsidiaries of Terumo Corporation of Japan that is focused exclusively on cardiovascular surgery specialties. For more information, visit www.terumocv.com

About Terumo Corporation

Terumo (TSE: 4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large. All brand names are trademarks or registered trademarks owned by TERUMO CORPORATION, its affiliates, or unrelated third parties.

Refer to this device's Instructions For Use (IFU) for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

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^1.  Oshita, T et al. A Better Predictor of Acute Kidney Injury After Cardiac Surgery: The Largest Area Under the Curve Below the Oxygen Delivery Threshold During Cardiopulmonary Bypass. J Am Heart Assoc. 2020;9: e015566. DOI: 10.1161/JAHA.119.015566.

^2.  Condello, I, etal. Association between oxygen delivery and cardiac index with hyperlactatemia during cardiopulmonary bypass. JTCVS Techniques. 2020; Vol 2: 92-99.

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SOURCE Terumo Cardiovascular

FAQ

What is the CDI OneView Monitoring System by Terumo Cardiovascular?

The CDI OneView Monitoring System is a next-generation platform that measures and displays up to 22 key patient parameters during cardiopulmonary bypass surgery, enhancing perfusion safety and improving patient outcomes.

When did Terumo Cardiovascular receive FDA 510(k) clearance for the CDI OneView Monitoring System?

Terumo Cardiovascular received FDA 510(k) clearance for the CDI OneView Monitoring System on May 28, 2024.

What are the new parameters measured by the CDI OneView Monitoring System?

The new parameters include measured flow (Q), cardiac index (CI), regional cerebral oxygen saturation (rSO2), oxygen extraction ratio (O2ER), Area Under the DO2 Curve (AUC), and measured arterial oxygen saturation (SaO2).

How does the CDI OneView Monitoring System benefit patients during cardiopulmonary bypass surgery?

The CDI OneView Monitoring System enhances perfusion safety by providing comprehensive, real-time data on multiple vital parameters, which helps in maintaining optimal levels and potentially reducing complications like acute kidney injury.

Who contributed to the development of the CDI OneView Monitoring System?

The development of the CDI OneView Monitoring System was influenced by extensive input from perfusionists and leading global cardiovascular institutions.