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A global leader in MedTech
In collaboration with clinicians and healthcare experts around the world, we develop innovative surgical technologies and solutions to help address some of the most pressing health challenges of our time, such as metabolic disease, cardiovascular disease and cancer.
1. For complete indications, contradictions, warnings, precautions, and adverse reactions, please reference Full Indications for Use and User Manual.
2.The software is designed to be used by trained professionals (including physicians, surgeons, and technicians) and is intended to assist the clinician who is responsible for making all final patient management decisions.
3. This product is not intended for use with or for the primary diagnostic interpretation for Mammography images.
4.Compared to previous generations of Enseal devices (099986‐210202).
5. As compared to devices with less than 360° degree shaft rotation (099992‐181108).
6. In benchtop testing on porcine arteries, vessels sealed with ENSEAL X1 Curved Jaw had a 22% higher average burst pressure than vessels sealed with LigaSure™ Maryland (LF1937), (1055mmHg vs. 862mmHg, p < 0.001). (145079‐200629)
7. In an acute porcine model, 104 of 105 vessels sealed maintained hemostasis during blood pressure challenge. During blood pressure challenge, systolic blood pressure was increased to at least 200 mmHg for a minimum of 10 minutes to simulate a hypertensive crisis. (140890‐200520).
8. Memon AG, Naeem Z, Zaman A, Zahid F (2016) Occupational health related concerns among surgeons. Int J Health Sci 10 (2): 279-291.
MONARCH® Platform Important Safety Information
Complications from bronchoscopy are rare and most often minor, but if they occur, may include breathing difficulty, vocal cord spasm, hoarseness, slight fever, vomiting, dizziness, bronchial spasm, infection, low blood oxygen, bleeding from biopsied site, or an allergic reaction to medications. Only rarely do patients experience other more serious complications (for example, collapsed lung, respiratory failure, heart attack and/or cardiac arrhythmia).