FDA approves hyperpolarized MRI contrast agent for evaluating lung ventilation
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The FDA has approved xenon Xe 129 hyperpolarized, or Xenoview, to use along with MRI to analyze lung ventilation among adults and children aged 12 years and older, according to a manufacturer-issued press release.
According to the release, this drug-device combination product is the first and sole inhaled MRI hyperpolarized contrast agent that helps in examining lung ventilation without exposing patients to ionizing radiation and its risks.
Patients receive Xenoview (Polarean Imaging) in a single 10 to 15 second breath hold MRI procedure, according to the release.
The current approval was based, in part, on data from two prospective, multicenter, randomized, open-label, cross-over clinical trials that evaluated the product in 31 patients undergoing evaluation for lung resection surgery and 49 patients undergoing evaluation for lung transplant surgery who all had various respiratory disorders.
When comparing Xenoview MRI to xenon Xe 133 scintigraphy among those being examined for possible lung resection surgery, results reported in the release showed that the mean within-patient difference in the predicted postoperative percentage of remaining lung ventilation was within a prespecified interval, with an observed estimate of 1.4% (95% CI, –0.8% to 3.6%).
Similar results were found among patients being examined for lung transplant surgery with an observed estimate of 1.6% (95% CI, –3.7% to 0.5%).
Adverse events observed among adults in the efficacy trials included oropharyngeal pain, headache and dizziness. Additionally, temporary decrease in oxygen saturation and temporary increase in heart rate were observed among patients aged 6 to 18 years in one published study on hyperpolarized xenon Xe 129.
Also, Xenoview inhalation can cause transient hypoxia and reduced image quality if given at the same time as supplemental oxygen, according to safety information included in the release.
“FDA approval represents achievement of a major milestone for Polarean’s technology,” Richard Hullihen, MBA, Polarean’s CEO, said in the release. “This was only possible in close collaboration with multiple research clinicians and scientists globally, who we thank for their tireless and enthusiastic work. Approval of Xenoview represents a major step forward in modern respiratory imaging and we are proud to have pioneered this exciting new technology for clinical use.”
Polarean also received clearances for two 510(k) devices, Xenoview VDP and Xenoview 3.0T Chest Coil, which will aid in the launch of Xenoview in the clinical marketplace, according to the release.