Breakthrough Clinical Results
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.
Key Highlights
- FDA grants IDE approval for pivotal clinical trial of Airiver Pulmonary DCB.
- Trial will assess safety and efficacy in up to 200 patients with central airway stenosis.
- Airiver DCB combines balloon dilation with localized paclitaxel delivery to prevent recurrence.
- Study compares Airiver DCB to standard-of-care bare balloon dilation.
Incidence and Prevalence
Global Incidence and Prevalence of Central Airway Stenosis
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.
Study Design Parameters
Study Design Parameters and Endpoints in Central Airway Stenosis Trials
Study Designs
- Cross-sectional, descriptive, prospective study (2010) with 180 subjects comparing Vitalograph-COPD-6 with conventional spirometry
- Single-arm, open-label study (2015) evaluating LVR coil treatment in homogeneous emphysema patients
- Validation study (2018) with 7 expert bronchoscopists and 7 general pulmonologists assessing SENSA software
- Retrospective single-center cohort study (2023) evaluating a novel segmentation-based volume rendering approach for benign central airway obstruction (BCAO)
- Pilot study (2024) with 10 patients evaluating a novel prototype measurement device (LJ system)
- Computational fluid dynamics analysis (2023) on 36 synthetic and 8 patient-specific airway models
Patient Populations
- Patients with tracheal stenosis with suspected benign etiology
- Patients with severe airway obstruction and hyperinflation
- Patients with Malignant Central Airway Obstruction (MCAO) from primary lung cancer or metastatic disease
- Patients with tracheal stenosis indicated for Y-stent placement or open surgery
- Patients with tracheoesophageal fistula
Measurement Methods
- Vitalograph-COPD-6 portable device versus conventional spirometry
- SENSA (System for Endoscopic Stenosis Assessment) for objective stenosis measurements
- Segmentation-based volume rendering approach using OsiriX software
- LJ system with probe, display box, encoder, and microcontroller
- 3D reconstruction with computational fluid dynamics simulations
- Pressure sensor plethysmography using two pressure sensors
Key Endpoints
- FEV₁/FEV₆ ratio compared to FEV₁/FVC for detecting airway obstruction
- Stenosis Index (SI) measurements with precision up to 99.5%
- Interrater reliability calculated by intraclass correlation coefficient (ICC)
- Pressure drop, area-average velocity, volume flow rate, wall shear stress, and airflow resistance
- 6-minute walking distance (6MWD) improvement from baseline
- Forced vital capacity (FVC) and residual volume measurements
- St. George's Respiratory Questionnaire scores for quality of life assessment
- Technical success and symptomatic relief in therapeutic bronchoscopy
Key Findings
- 70% constriction marks the onset of a precipitous decrease in airflow
- ICC of 0.88 (95% CI, 0.84 to 0.93) for volume rendering approach, indicating good to excellent agreement
- ICC of 0.38 (95% CI, 0.20 to 0.55) for subjective methods, indicating poor to fair agreement
- Tracheal stenosis significantly influences peripheral bronchi resistance
- LVR coil treatment improves hyperinflation, airway resistance, exercise capacity and quality of life
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In a 2015 multicenter registry study of therapeutic bronchoscopy for MCAO:
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Technical success (reopening airway lumen to >50% of normal) achieved in 93% of procedures
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Clinically significant improvements in dyspnea occurred in 48% of patients
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Clinically significant improvements in HRQOL occurred in 42% of patients
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Endobronchial obstruction and stent placement were associated with success
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ASA score >3, renal failure, primary lung cancer, left mainstem disease, and tracheoesophageal fistula were associated with failure
Drug used in other indications
No Information Available on Airiver Pulmonary Drug Coated Balloon Trials
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.