Airiver Medical has treated the first patient in its RESTORE-2 pivotal clinical trial assessing the ESSpand Sinus drug-coated balloon (DCB) for chronic rhinosinusitis (CRS).
The treatment took place at Advanced ENT and Allergy in Louisville, Kentucky, US, administered by Dr Andrew Gould.
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The trial is enrolling up to 300 patients across the US with CRS, both with and without nasal polyps, to evaluate the efficacy and safety of the investigational ESSpand DCB when used in conjunction with endoscopic sinus surgery.
ESSpand is designed to maintain symptom relief and discourage re-narrowing of sinus drainage pathways by deploying a layer of paclitaxel during balloon dilation of restricted sinus passages.
The trial is intended to provide data for Airiver Medical’s regulatory submission to the US Food and Drug Administration (FDA) and potential commercial launch of the ESSpand DCB in the country.
Airiver Medical CEO Paul Vajgrt said: “This is an important milestone as we’re one step closer to providing patients suffering from CRS and physicians with our novel treatment option that has the potential for long-term relief with fewer treatments, which is a significant gap in current treatment options.”
CRS is defined as inflammation of the nose and paranasal sinuses persisting for at least three months despite intervention.
Separately, Airiver Medical is enrolling participants in the OXYGEN-RCT pivotal clinical trial, which evaluates the pulmonary DCB for central airway stenosis. This study has currently treated 21 out of a planned 200 patients.
The ESSpand DCB remains an investigational device and has not received marketing authorisation from the FDA or been made available for sale in the US.
In March 2026, Airiver Medical secured the FDA breakthrough device designation for its pulmonary DCB intended for the treatment of central airway stenosis.
