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.

HPX Measurement Station

HPX Measurement Station

The HPX Measurement Station measures 34.25″ D x 31.25″ W x 67.63″ H.

Once the xenon Xe 129 is hyperpolarized it becomes XENOVIEW™ and is dispensed into a XENOVIEW™ Dose Delivery Bag. The dose of XENOVIEW™ can be stored at room temperature for up to 60 minutes on the measurement station. The HPX Measurement Station is used to measure both the volume and dose equivalent (DE) in the XENOVIEW™ Dose Delivery Bag no more than 5 minutes before patient inhalation. The DE measurement should be at least 75 mL to produce a high-quality image.

Training and Support

All users receive hands-on training to operate the HPX Hyperpolarizer System in conjunction with an MRI scanner to perform pulmonary imaging.