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A new US-based clinical study has validated the accuracy of Senzime’s TetraGraph system, a neuromuscular monitoring device. The study, published on October 18, 2024, in the Journal of Clinical Monitoring and Computing, compared the TetraGraph to benchmark mechanomyography (MMG) technology. Key findings include:
1. The TetraGraph demonstrated 97.9% accuracy compared to MMG.
2. It is the first study to clinically validate a portable EMG-only system at all levels of neuromuscular block.
3. Results suggest TetraGraph’s performance is superior to other commercially available neuromuscular monitoring systems.
4. The study was conducted at the Medical College of Wisconsin, led by Prof. Thomas Ebert.
Senzime’s Chief Medical Officer, Dr. Sorin J. Brull, emphasized the importance of the TetraGraph’s precision, particularly during laparoscopic and robotic surgeries. The researchers concluded that EMG monitors like TetraGraph should become a clinical standard for all phases of neuromuscular block.
Un nuovo studio clinico condotto negli Stati Uniti ha validato l’accuratezza del systema TetraGraph di Senzime, un dispositivo per il monitoraggio neuromuscolare. Lo studio, pubblicato il 18 ottobre 2024 nella rivista Journal of Clinical Monitoring and Computing, ha confrontato il TetraGraph con la tecnologia di meccanomiografia (MMG) di riferimento. I risultati principali includono:
1. Il TetraGraph ha dimostrato un’accuratezza del 97,9% rispetto alla MMG.
2. È il primo studio a validare clinicamente un sistema portatile basato esclusivamente su EMG a tutti i livelli di blocco neuromuscolare.
3. I risultati suggeriscono che le prestazioni del TetraGraph sono superiori rispetto ad altri sistemi di monitoraggio neuromuscolare disponibili in commercio.
4. Lo studio è stato condotto presso il Medical College of Wisconsin, sotto la guida del Prof. Thomas Ebert.
Il Direttore Medico di Senzime, Dr. Sorin J. Brull, ha sottolineato l’importanza della precisione del TetraGraph, in particolare durante le chirurgie laparoscopiche e robotiche. I ricercatori hanno concluso che i monitor EMG come il TetraGraph dovrebbero diventare uno standard clinico per tutte le fasi del blocco neuromuscolare.
Un nuevo estudio clínico basado en Estados Unidos ha validado la precisión del sistema TetraGraph de Senzime, un dispositivo de monitoreo neuromuscular. El estudio, publicado el 18 de octubre de 2024 en el Journal of Clinical Monitoring and Computing, comparó el TetraGraph con la tecnología de mecanomiografía (MMG) de referencia. Los hallazgos clave incluyen:
1. El TetraGraph demostró una precisión del 97,9% en comparación con la MMG.
2. Es el primer estudio en validar clínicamente un sistema portátil que utiliza únicamente EMG en todos los niveles de bloque neuromuscular.
3. Los resultados sugieren que el rendimiento del TetraGraph es superior al de otros sistemas de monitoreo neuromuscular disponibles comercialmente.
4. El estudio fue realizado en el Medical College of Wisconsin, liderado por el Prof. Thomas Ebert.
El Director Médico de Senzime, Dr. Sorin J. Brull, enfatizó la importancia de la precisión del TetraGraph, especialmente durante cirugías laparoscópicas y robóticas. Los investigadores concluyeron que los monitores de EMG como el TetraGraph deberían convertirse en un estándar clínico para todas las fases del bloqueo neuromuscular.
미국에서 진행된 새로운 임상 연구가 센지메의 테트라그래프 시스템의 정확성을 검증했습니다. 이 연구는 2024년 10월 18일 《임상 모니터링 및 컴퓨팅 저널》에 발표되었으며, 테트라그래프와 벤치마크 기계 생리학(MMG) 기술을 비교했습니다. 주요 발견 사항은 다음과 같습니다:
1. 테트라그래프는 MMG에 비해 97.9%의 정확성을 보였습니다.
2. 모든 수준의 신경근 차단에서 EMG 전용 포터블 시스템을 임상적으로 검증한 첫 번째 연구입니다.
3. 결과는 테트라그래프의 성능이 상용 신경근 모니터링 시스템보다 우수함을 시사합니다.
4. 이 연구는 위스콘신 의대에서 진행되었으며, 토마스 에버트 교수의 지도 아래 이루어졌습니다.
센지메의 최고 의료 책임자, 드 소린 J. 브룰은 특히 복강경 및 로봇 수술 중 테트라그래프의 정밀도 중요성을 강조했습니다. 연구자들은 EMG 모니터인 테트라그래프가 신경근 차단의 모든 단계에서 임상 표준이 되어야 한다고 결론지었습니다.
Une nouvelle étude clinique basée aux États-Unis a validé la précision du système TetraGraph de Senzime, un dispositif de surveillance neuromusculaire. L’étude, publiée le 18 octobre 2024 dans le Journal of Clinical Monitoring and Computing, a comparé le TetraGraph à la technologie de mécanomiographie (MMG) de référence. Les résultats clés incluent :
1. Le TetraGraph a montré une précision de 97,9 % par rapport à la MMG.
2. C’est la première étude à valider cliniquement un système portable uniquement EMG à tous les niveaux de blocage neuromusculaire.
3. Les résultats suggèrent que la performance du TetraGraph est supérieure à celle des autres systèmes de surveillance neuromusculaire disponibles dans le commerce.
4. L’étude a été menée au Medical College of Wisconsin, sous la direction du Prof. Thomas Ebert.
Le directeur médical de Senzime, Dr. Sorin J. Brull, a souligné l’importance de la précision du TetraGraph, en particulier lors des chirurgies laparoscopiques et robotiques. Les chercheurs ont conclu que les moniteurs EMG comme le TetraGraph devraient devenir une norme clinique pour toutes les phases du blocage neuromusculaire.
Eine neue klinische Studie aus den USA hat die Genauigkeit des TetraGraph-Systems von Senzime, einem neuromuskulären Überwachungsgerät, validiert. Die Studie, veröffentlicht am 18. Oktober 2024 im Journal of Clinical Monitoring and Computing, verglich den TetraGraph mit der Benchmark-Technologie der Mechanomyografie (MMG). Wichtige Ergebnisse sind:
1. Der TetraGraph zeigte eine Genauigkeit von 97,9% im Vergleich zur MMG.
2. Es ist die erste Studie, die ein tragbares EMG-Only-System auf allen Ebenen der neuromuskulären Blockade klinisch validiert.
3. Die Ergebnisse deuten darauf hin, dass die Leistung des TetraGraph überlegen ist im Vergleich zu anderen kommerziell erhältlichen neuromuskulären Überwachungssystemen.
4. Die Studie wurde am Medical College of Wisconsin unter der Leitung von Prof. Thomas Ebert durchgeführt.
Der Hauptmediziner von Senzime, Dr. Sorin J. Brull, betonte die Bedeutung der Präzision des TetraGraph, insbesondere während laparoskopischer und robotergestützter Operationen. Die Forscher kamen zu dem Schluss, dass EMG-Monitore wie der TetraGraph klinischer Standard für alle Phasen der neuromuskulären Blockade werden sollten.
Positive
- TetraGraph system demonstrated 97.9% accuracy compared to benchmark MMG technology
- First study to clinically validate a portable EMG-only system at all levels of neuromuscular block
- Results suggest TetraGraph’s performance is superior to other commercially available neuromuscular monitoring systems
- Researchers propose EMG monitors like TetraGraph to become a clinical standard for all phases of neuromuscular block
UPPSALA, SWEDEN / ACCESSWIRE / October 19, 2024 / Senzime (STO:SEZI)(OTCQX:SNZZF) Philadelphia, ANESTHESIOLOGY 2024 – A just published US-based study validated Senzime’s TetraGraph system for accuracy by comparing data to benchmark mechanomyography (MMG) technology. This was the first study to clinically validate a portable EMG-only system at all levels of neuromuscular block. The results confirmed the overall accuracy of the TetraGraph system and provided evidence that it is superior in accuracy to other commercially available and validated neuromuscular monitoring systems (ref 1).
The study “Train-of-Four Ratio, Counts and Post Tetanic Counts with the TetraGraph Electromyograph in Comparison to Mechanomyography” published 18th of October, 2024, in the Journal of Clinical Monitoring and Computing , was performed at the Medical College of Wisconsin, USA, under the lead of anesthesiologist Prof. Thomas Ebert.
The TetraGraph was used in patients undergoing surgery and various degrees of neuromuscular block. Simultaneous recordings from the TetraGraph neuromuscular monitor and a MMG monitor were obtained. The TetraGraph’s accuracy compared to MMG was very high at 97.9%, and the small standard deviation and narrow range of responses demonstrate that it is even more repeatable than the comparator “gold standard” MMG. Previously published validation studies of commercially available monitors and EMG-devices have not demonstrated equally high correlation to MMG at all levels of block as the TetraGraph (ref 2,3)
“We can be very encouraged by these independently obtained results that clinically validate the TetraGraph’s precision. This is a professionally conducted study and the very first to clinically validate a portable EMG-only system at all levels of neuromuscular block. The data not only confirm that the TetraGraph currently has the industry’s most accurate EMG algorithm, but also that its clinical precision is maintained at deep levels of block; this is novel and particularly important during laparoscopic and robotic surgeries,” comments Sorin J. Brull, MD, Chief Medical Officer of Senzime.
The researchers concluded that the prospective evaluation of the TetraGraph quantitative system proved that it was accurate and proposed that EMG monitors such as the TetraGraph “to become a clinical standard for all phases of neuromuscular block.”
References:
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Wedemeyer Z, et. al. Anesthesiology , 2024.
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Bowdle A, et al. Anaesthesia , 2020.
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Wedemeyer, Z, et al. Journal of Clinical Monitoring and Computing , 2023.
For further information, please contact:
Philip Siberg, CEO of Senzime AB
Phone: +46 (0) 707 90 67 34, e-mail: philip.siberg@senzime.com
About Senzime
Senzime, headquartered in Sweden, is a leading medical device company that develops, manufactures, and markets CE- and FDA-cleared patient monitoring systems. The company provides an innovative portfolio of solutions, including the TetraGraph® and ExSpiron® 2Xi for accurate monitoring of neuromuscular and respiratory functions, typically under and after surgery. The goal is to help eliminate in-hospital complications, and radically reduce health care costs related to surgical and high acuity procedures.
Senzime targets a market opportunity valued more than SEK 40 billion per year, and operates with sales teams in the world’s leading markets. The company’s shares are listed on Nasdaq Stockholm Main Market (Nasdaq: SEZI) and cross-traded in the US on the OTCQX market (OTCQX: SNZZF). More information is available at senzime.com .
Attachments
New clinical study confirms the industry leading performance of Senzime’s TetraGraph system
SOURCE: Senzime
View the original press release on accesswire.com
FAQ
What were the key findings of the clinical study on Senzime’s TetraGraph system (SNZZF)?
The study found that Senzime’s TetraGraph system demonstrated 97.9% accuracy compared to benchmark MMG technology. It was the first to clinically validate a portable EMG-only system at all levels of neuromuscular block, and results suggest its performance is superior to other commercially available neuromuscular monitoring systems.
Where and when was the clinical study on Senzime’s TetraGraph (SNZZF) conducted?
The study was conducted at the Medical College of Wisconsin, USA, under the lead of anesthesiologist Prof. Thomas Ebert. It was published on October 18, 2024, in the Journal of Clinical Monitoring and Computing.
What did researchers conclude about Senzime’s TetraGraph system (SNZZF) in the clinical study?
Researchers concluded that the TetraGraph quantitative system was accurate and proposed that EMG monitors like TetraGraph should become a clinical standard for all phases of neuromuscular block. They emphasized its precision, particularly during laparoscopic and robotic surgeries.
How does the accuracy of Senzime’s TetraGraph (SNZZF) compare to other neuromuscular monitoring systems?
According to the study, Senzime’s TetraGraph system demonstrated superior accuracy compared to other commercially available and validated neuromuscular monitoring systems. It showed 97.9% accuracy compared to benchmark MMG technology, with a small standard deviation and narrow range of responses.
