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 Hyperpolarizer

HPX Hyperpolarizer

The HPX Hyperpolarizer measures 67” D x 28” W x 63.25” H.

The HPX Hyperpolarizer processes a Xenon Xe 129 Gas Blend into pure hyperpolarized xenon Xe 129 by using circularly polarized laser light. Hyperpolarized xenon Xe 129 creates a unique MRI signal (resonance frequency) that can be detected to determine its distribution throughout the lungs. Compared to air that is typically within the lung, hyperpolarized xenon Xe 129 enhances the MRI signal by a factor of 100,000.

HPX Gas Manifold

The HPX Gas Manifold is an ultra-high purity (UHP) gas pressure regulation and purification system that allows two Xenon Xe 129 Gas Blend cylinders, one NF-grade UHP nitrogen cylinder, and one industrial nitrogen cylinder to be connected to the HPX Hyperpolarizer.

Storage and Requirements

The Xenon Xe 129 Gas Blend for preparation of XENOVIEW™ is supplied in size 302 aluminum cylinders as a compressed gas under high pressure and should be stored at room temperature 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F).

HPX Gas Manifold

The HPX Gas Manifold measures 48.25″ D x 28.25″ W x 9.25″ H.

Facility Requirements

An MRI scanner is not part of the HPX Hyperpolarization System, but is an essential component of the imaging workflow. The MRI scanner must be an FDA cleared medical device equipped with multi-nuclear (broadband) spectroscopy (MNS) capabilities and have available an appropriate imaging protocol to detect a xenon Xe 129 signal.

The HPX Hyperpolarizer is typically installed in a separate room near the MRI suite for ease of radiology workflow. It measures 67″ L x 28″ W x 63.25″ H and requires a minimum room size of 10′ x 10′, 3-phase electrical power, and compressed air. The room must be sufficiently well ventilated to remove the heat generated by the laser and cell heater.

WORKFLOW

  • Compatible with most existing institutional MRI equipment fitted with a multi-channel amplifier
  • Programmable Gradient Related Echo (GRE) pulse sequences for xenon Xe 129 MRI scans can be easily integrated into existing radiology workflows

PATIENT EXPERIENCE

  • Non-effort dependent procedure
  • Short duration in MRI scanner and patient’s head is positioned near opening during procedure
  • No radiation exposure
  • Inert gas is rapidly exhaled (majority of dose gone within a minute) and no known systemic metabolism or off-organ toxicity

OUTPUT

  • Standard DICOM output for standard PACS workstations and/or import into post-processing software programs
  • Classified ventilation images, summary reports, and data files containing quantitative statistical analysis.

DICOM, Digital Imaging and Communications in Medicine; PACS, picture archiving and communication system.

HPX Measurement Station