Polarean’s Xenoview (xenon Xe 129 hyperpolarized) Receives the US FDA’s Approval for Lung Ventilation
Shots:
- The US FDA has approved Xenoview, a hyperpolarized contrast agent indicated for use with MRI for lung ventilation in adults & pediatric patients aged ≥12yrs. The product is administered by oral inhalation as a single 10-15 second breath hold MRI procedure
- The approval was based on the P-III trial (Study 1 & 2) evaluating Xenoview MRI vs xenon Xe 133 scintigraphy in 80 patients. (Study 1) patients evaluated for lung resection surgery & in (Study 2) for lung transplant surgery
- Both the trial met their 1EPs i.e., the (Study 1 &2) trial results showed observed estimation of 1.4% & 1.6% for the mean within-patient difference was within a predetermined equivalence interval in the postoperative percentage of remaining & overall lung ventilation b/w Xenoview & xenon Xe 133 imaging
Ref: Globenewswire | Image: Polarean
Related News:- Polarean Reports the NDA Submission of Hyperpolarised 129Xenon Gas Drug-Device Diagnostic to the US FDA for Lung Imaging
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