Frequently Asked Questions About XENOVIEW™
Is XENOVIEW™ approved by the Food and Drug Administration (FDA)?
Yes, XENOVIEW™ received FDA approval on December 23, 2022.
What is the indication for XENOVIEW™?
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.
Who do I contact with questions about coding and reimbursement for XENOVIEW™?
How do I purchase an HPX Hyperpolarization System?
What consumables are needed to administer XENOVIEW™?
The consumables include the Xenon Xe 129 Gas Blend cylinder and XENOVIEW™ Dose Delivery Bags. The multi-dose Gas Blend cylinder has a volume of 6,350 liters and contains approximately 120 to 150 doses. Each dose is dispensed into a single-use XENOVIEW™ Dose Delivery Bag, which are supplied in a carton of 50 with attachable mouthpieces and affixable dose labels.
How do I place an order for a Xenon Xe 129 Gas Blend cylinder or XENOVIEW™ Dose Delivery Bags?
How much xenon is used for each XENOVIEW™ image?
The recommended dose is 75 mL to 100 mL dose equivalent (DE) of hyperpolarized xenon Xe 129 (250 mL to 750 mL total xenon) for each image. The mean xenon gas volume per XENOVIEW™ dose administered in the clinical trials was 330.2 mL.
What personnel are required to produce XENOVIEW™ with the HPX Hyperpolarizer?
All users receive extensive conceptual and hands-on training to safely operate the HPX Hyperpolarizer. No technical certification is required to operate the polarizer in conjunction with an MRI scanner to perform pulmonary imaging.
What infrastructure (or space) is needed to house the HPX Hyperpolarization System?
A 10′ x 10′ room is adequate to house the HPX Hyperpolarization System. The room should be in reasonable proximity to the MRI suite and should be able to be secured. Basic requirements include access to compressed air, liquid nitrogen, and air conditioning to maintain room at ≤72°F.
Does Polarean offer a Service Agreement?
What is the Standard Warranty for the HPX Hyperpolarization System?
Polarean offers an initial one-year warranty period that includes unlimited coverage for parts and labor.
How often does the HPX Hyperpolarization System require preventive maintenance?
Preventative maintenance is required once a year.
What is included in a preventive maintenance visit?
The HPX Hyperpolarization System will be serviced, calibrated, and optimized. A refresher training for system operators will be provided upon customer’s request.