Real-World Safety and Performance of The Mesire Sinus Balloon Catheter: A Retrospective Multicenter Study
Keywords:
Balloon sinuplasty; Chronic sinusitis; Paranasal Sinus Diseases; Pediatrics; Sinusitis.Abstract
Background Chronic rhinosinusitis (CRS) is a common, persistent inflammatory disease of the sinonasal mucosa with a profound effect on patients’ quality of life. Although endoscopic sinus surgery (ESS) is an effective standard method of treatment, complications such as postoperative bleeding, mucosal damage and scarring may result. Balloon catheter dilation (BCD) has been developed as a less invasive procedure to recover sinus ventilation and, more importantly, to preserve the mucosal integrity.
Aim The aim of the study was to assess the safety and performance of the Mesire™ Sinus Balloon Catheter in patients with sinonasal ostial obstruction.
Methods This retrospective, multicentre post-marketing clinical follow-up study enrolled 111 patients who had undergone sinus ostial dilation with the Mesire™ Sinus Balloon Catheter in 12 clinical centres in India. The primary endpoint of the study was a composite of postoperative complication rate and revision surgery frequency during a 6-month follow-up. Secondary endpoints were adverse events, revision surgery rate, nasal bleeding, and hospital stay.
Results All 111 enrolled patients (71 males and 40 females; mean age = 39.73 ± 10.74) completed the 6-month follow-up, with no dropouts or deviations from protocol supervision. Chronic sinusitis was the main diagnosis in 87.39% of instances. The frontal (66.67%) and maxillary (47.75%) sinuses were the most involved. All procedures were performed with technical success (100%) and without device-related complications. No intra- or postoperative complications, adverse events, or revision surgery occurred during the study period.
Conclusions The Mesire™ Sinus Balloon Catheter achieved a 100% success rate at 6 months of follow-up, with no complications or need for revision. These results demonstrate its safety and effectiveness as a feasible, minimally invasive option that preserves sinus mucosa compared to standard ESS.
