A US study is evaluating a drug-coated balloon designed to improve outcomes for chronic rhinosinusitis patients undergoing sinus surgery.
RT’s Three Key Takeaways
- Pivotal Clinical Trial: Airiver Medical has treated the first patient in a US study assessing a drug-coated balloon for the treatment of chronic rhinosinusitis.
- Drug-Delivery Technology: The device uses a paclitaxel coating during balloon dilation to help prevent tissue scarring and the renarrowing of nasal passages.
- Clinical Goal: The study seeks to provide a long-term solution for the millions of patients who experience returning symptoms after standard medical treatments or surgeries.
Airiver Medical has treated the first patient in its RESTORE-2 US pivotal clinical trial of the Airiver ESSpand Sinus Drug Coated Balloon (DCB), according to the company. The study evaluates the safety and efficacy of the technology in patients with chronic rhinosinusitis (CRS).
Andrew Gould, a board-certified ear, nose, and throat (ENT) specialist and director of research at Advanced ENT and Allergy in Louisville, Ky, treated the first patient.
“We’re thrilled to have treated the first patient in this important study and very hopeful that this will provide meaningful improvements in outcomes for endoscopic sinus surgery,” said Andrew Gould, board-certified ENT and director of research at Advanced ENT and Allergy, in a news release. “If the RESTORE-2 trial is successful, this technology could help patients avoid further surgeries, oral steroids, and expensive biologic therapy – a huge potential win for patients and the healthcare system.”
The landmark study is enrolling up to 300 patients across the US to assess the ESSpand DCB as an adjunct to endoscopic sinus surgery (ESS). The device applies a thin layer of a proprietary paclitaxel drug coating to tissue during balloon dilation of restricted sinus drainage passageways to prevent scarring and renarrowing. The study results are intended to support a regulatory submission to the Food and Drug Administration (FDA).
“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,” said Paul Vajgrt, chief executive officer of Airiver Medical, in a news release.
CRS is defined as symptomatic inflammation of the nose and paranasal sinuses that lasts for at least three months. More than 14 million US adults have the condition, and 4 million of those patients report difficulty finding relief through traditional medical treatments, according to the news release. Even after initial surgery, symptoms often return, leading many patients to undergo at least one additional surgery.
In addition to the RESTORE-2 trial, Airiver Medical is enrolling patients in the OXYGEN-RCT US study to assess the Airiver Pulmonary DCB in patients with central airway stenosis.
The Airiver DCB is an investigational device and has not received marketing authorization from the FDA.
