Ion is for sale in the U.S.
Outside of the U.S., Ion is not CE Marked and not for human use. Ion cannot be placed on the market or put into service. Ion may not have regulatory approvals in all markets. Please check with your local Intuitive representative.
Important Safety Information
Risks associated with bronchoscopy through an endotracheal tube and under general anesthesia are infrequent and typically minor, and may include but are not limited to: sore throat, hoarseness, respiratory complications including dyspnea or hypoxemia, airway injury, bronchospasm, laryngospasm, fever, hemoptysis, chest or lung infection including pneumonia, lung abscess or an adverse reaction to anesthesia. Although rare, the following complications may also occur: bleeding, pneumothorax (collapsed lung), cardiac related complications, respiratory failure, air embolism, or death. As with other medical procedures, there may be additional risks associated with the use of general anesthesia and/or endotracheal intubation which are not listed above; you should consult a health care professional regarding these and other potential risks.
Procedures using the Ion Endoluminal System may be associated with longer procedure and/or longer anesthesia time.
