FDA approves Xenoview for use with MRI for the evaluation of lung ventilation
Polarean Imaging plc the medical imaging technology company, announces that the FDA has granted approval for its drug device combination product, 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. Xenoview has not been evaluated for use with lung perfusion imaging.
Xenoview expands the opportunity for pulmonary medicine to utilize the first and only inhaled MRI hyperpolarized contrast agent for novel visualization of lung ventilation without exposing patients to any ionizing radiation and its associated risks. The dose of Xenoview, created through the Polarean HPX hyperpolarization system, is administered in a single 10-15 second breath hold MRI procedure.
Polarean also announces that, simultaneously with the approval of the Xenoview NDA, two 510(k) devices were cleared by the FDA that will further support a successful launch of the technology into the clinical marketplace: i. Xenoview VDP is image processing software that analyzes a pulmonary hyperpolarized 129-Xe MR image and a proton chest MR image to provide visualization and evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. This image analysis platform quantifies normalized xenon intensity of a ventilated space using a pulmonary hyperpolarized 129-Xe ventilation MR image and accompanying proton chest MR image. The software will be used by clinicians to assist in the interpretation and numerical classification of hyperpolarized 129-Xe ventilation MR images.
ii.The Polarean Xenoview 3.0T Chest Coil is a flexible, single channel, transmit-receive (T/R) RF coil tuned to 129Xe frequency on a 3.0T MRI magnetic field of a compatible MRI scanner. The Polarean Xenoview 3.0T Chest Coil is indicated to be used in conjunction with compatible 3.0T MRI scanners and approved xenon Xe 129 hyperpolarized for oral inhalation for evaluation of lung ventilation in adults and pediatric patients aged 12 years and older. The Chest Coil is intended to be worn by a patient who inhales hyperpolarized 129Xe gas (Xenoview) to obtain an MR image of the regional distribution of hyperpolarized 129Xe in the lungs.
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