Airiver Medical announced that it has received Investigational Device Exemption (IDE) approval from the FDA to conduct a pivotal clinical trial of its Airiver Pulmonary Drug Coated Balloon (DCB) for the treatment of benign central airway stenosis. The nationwide study will enroll up to 200 patients and compare the Airiver DCB, which combines balloon dilation with localized paclitaxel delivery, to standard-of-care bare balloon dilation. The company believes this minimally invasive approach could offer a durable treatment option preventing recurrence of this serious condition, for which there is currently no optimal treatment. This is Airiver Medical's first IDE study submission and approval.
Based on a comprehensive review of recent literature, there is a notable gap in epidemiological data regarding the global incidence and prevalence of central airway stenosis. Current PubMed-indexed research does not provide specific global incidence rates for central airway stenosis or its subtypes, including tracheal stenosis, main bronchial stenosis, and subglottic stenosis.
The most recent publications from 2022 only mention "scarring central airway stenosis" as a condition manageable through various interventions, without providing epidemiological data on its occurrence worldwide. The available literature primarily consists of case reports rather than large-scale epidemiological studies.
For instance, one 2022 publication describes two case reports of tracheobronchial stenosis following injury that were treated with pirfenidone in combination with interventional management. Another publication from the same year details a single case of a 57-year-old man with high grade epithelioid angiosarcoma of the right lung and pleura who required placement of a tracheal stent.
Despite the clinical significance of central airway stenosis, there appears to be a lack of comprehensive epidemiological research that would provide reliable estimates of its global incidence or prevalence rates. The absence of such data represents a significant knowledge gap in understanding the true burden of this condition across different populations and geographical regions.
The literature does not currently offer stratified data by etiology such as post-intubation, neoplastic, inflammatory, idiopathic, or traumatic causes. Similarly, there is no information available regarding how these rates might vary by geographical region, patient demographics, or healthcare infrastructure.
This lack of epidemiological data highlights the need for more robust, population-based studies to better understand the true global burden of central airway stenosis and inform appropriate resource allocation for its management.
In a 2015 multicenter registry study of therapeutic bronchoscopy for MCAO:
Technical success (reopening airway lumen to >50% of normal) achieved in 93% of procedures
Clinically significant improvements in dyspnea occurred in 48% of patients
Clinically significant improvements in HRQOL occurred in 42% of patients
Endobronchial obstruction and stent placement were associated with success
ASA score >3, renal failure, primary lung cancer, left mainstem disease, and tracheoesophageal fistula were associated with failure
After thorough review, there is no specific information available regarding the Airiver Pulmonary Drug Coated Balloon with paclitaxel being trialed for indications other than central airway stenosis. The requested details about alternative indications and intervention models for clinical trials involving this specific device cannot be provided.
While drug-coated balloons using paclitaxel and sirolimus coatings exist for various applications in interventional medicine, no specific data about the Airiver brand or its clinical trial programs beyond central airway stenosis applications is present in the available information.
For accurate and current information about ongoing clinical trials for this device, consulting clinical trial registries such as ClinicalTrials.gov or contacting the device manufacturer directly would be recommended.