According to Polarean Imaging, the FDA has approved the company’s NDA for its Xenoview inhaled xenon-129 gas blend, a hyperpolarized contrast agent for MRI imaging of lung ventilation. Xenoview is approved for use in patients aged 12 and over. The agency also cleared two Polarean 510(k)s, one for a chest coil “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” and the other for software “to provide visualization and evaluation of lung ventilation.”
The company said that the approval was based on results from two clinical trials that compared Xenoview MRI to xenon-133 scintigraphy. One of the trials enrolled participants who were assessed for possible lung transplantation, the other enrolled patients who were assessed for possible lung resection.
Polarean CEO Richard Hullihen commented, “FDA approval represents achievement of a major milestone for Polarean’s technology. 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. The commercial team at Polarean is prepared to rapidly launch Xenoview for clinical application.”
Read the Polarean Imaging press release.
