Important Safety Information

Indication
XENOVIEW™, prepared from the Xenon Xe 129 Gas Blend, is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.

Limitations of Use
XENOVIEW has not been evaluated for use with lung perfusion imaging.

CONTRAINDICATIONS
None.

WARNINGS AND PRECAUTIONS
Risk of Decreased Image Quality from Supplemental Oxygen: Supplemental oxygen administered simultaneously with XENOVIEW inhalation can cause degradation of image quality. For patients on supplemental oxygen, withhold oxygen inhalation for two breaths prior to XENOVIEW inhalation, and resume oxygen inhalation immediately following the imaging breath hold.

Risk of Transient Hypoxia: Inhalation of an anoxic gas such as XENOVIEW may cause transient hypoxemia in susceptible patients. Monitor all patients for oxygen saturation and symptoms of hypoxemia and treat as clinically indicated.

ADVERSE REACTIONS
Adverse Reactions in Adult Patients: The adverse reactions (> one patient) in efficacy trials were oropharyngeal pain, headache, and dizziness.

Adverse Reactions in Pediatric Patients: In published literature in pediatric patients aged 6 to 18 years, the following transient adverse reactions were reported: blood oxygen desaturation, heart rate elevation, numbness, tingling, dizziness, and euphoria. In at least one published study of pediatric patients aged 6 to 18 years, transient decrease in SpO2% and transient increase in heart rate were reported following hyperpolarized xenon Xe 129 administration. XENOVIEW is not approved for use in pediatric patients less than 12 years of age.

Please see full Prescribing Information.

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What Is XENOVIEW™?

Hyperpolarization means aligning (polarizing) the nuclei of gases to a much greater extent than what is achieved by a magnetic resonance imaging (MRI) scanner. When used in conjunction with MRI, XENOVIEW™ offers a fundamentally new and non-invasive lung imaging platform for patients undergoing evaluation of lung ventilation.

XENOVIEW™ is a hyperpolarized contrast agent
XENOVIEW™ illuminates distribution of gas in the lungs and allows clinicians to evaluate regional lung ventilation

How Is XENOVIEW™ Produced?

The HPX Hyperpolarizer transforms Xenon Xe 129 Gas Blend into a hyperpolarized state by placing a non-radioactive isotope of the xenon source gas into a beam of polarized laser light in the presence of very small amounts of an alkali metal. This process leaves the xenon Xe 129 chemically unchanged, but with magnetically aligned nuclei.

Process Overview

Device (3 components)

Administration

HPX Gas Manifold

HPX Gas
Manifold

HPX Hyperpolarizer

HPX
Hyperpolarizer

HPX Measurement Station

HPX Measurement Station

Administer Dose

Not an actual patient or technician.

Device (3 components)

HPX Gas Manifold

HPX Gas
Manifold

HPX Hyperpolarizer

HPX
Hyperpolarizer

HPX Measurement Station

HPX Measurement Station

Administration

Administer Dose

Not an actual patient or technician.