Polarean (AIM: POLX), a commercial-stage medical device leader in advanced MRI scanning of the lungs, announces that the
The code (C9791) enables healthcare providers a path to bill for “magnetic resonance imaging with inhaled hyperpolarized xenon-129 contrast agent, chest, including preparation and administration of agent”. This was announced as part of the release of the
“We have been working diligently with CMS, our clinicians and hospital-based billing stakeholders over the past several months and view this as an important step towards enhancing accessibility to this innovative technology,” said
About Polarean (www.polarean.com)
The Company and its wholly owned subsidiary,
Contacts:
Polarean:
Chief Financial Officer
+1 (919) 206-7900, ext. 117
cosborne@polarean.com
Investors:
+44 (0)20 7933 8780
polarean@wallbrookpr.com
Media Contact:
+1 (919) 206-7900, ext. 136
mcaissie@polarean.com
XENOVIEW 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 desaturation 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 and Adolescent Patients: In published literature in pediatric patients aged 6 to 18, 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 was 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 at www.xenoview.net
POL-PR-2310
Polarean:Chuck Osborne Chief Financial Officer +1 (919) 206-7900, ext. 117 cosborne@polarean.com Investors:Anna Dunphy /Phillip Marriage +44 (0)20 7933 8780 polarean@wallbrookpr.com Media Contact:Michelle Caissie +1 (919) 206-7900, ext. 136 mcaissie@polarean.com
Source: Polarean
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