Sinus dilation can be an unpleasant procedure for patients who are not completely knocked out on anesthesia. Having something shoved up the nose and mechanically expanded can remind one of that unpleasant Total Recall scene with Arnold Schwarzenegger, and it’s not too far from reality. A new implant and delivery system from SinuSys Corporation, of Palo Alto, CA, has just been cleared by the FDA that aims to make dilation of maxillary sinus ostia much more acceptable for the patient under local anesthesia.
The Vent-Os system is based on an implant that expands in diameter from 3mm to 5mm slowly over an hour. The implant absorbs mucosal fluids to power its expansion, and so is not powered by any sort of spring or battery. Implantation takes just a few minutes, and after the patient spends an hour in the waiting room, the implant is removed using the same device used for placement.
The system received European approval in September of 2012.
From the announcement:
The Vent-Os System achieved post-procedural patency in 95 percent of the sinus ostia treated in a multi-center study and submitted as part of the Company’s FDA application; five percent of the treated ostia could not be visualized. In the study, the Vent-Os device was inserted into the maxillary sinus opening at the beginning of the procedure and removed after 60 minutes. No adverse events occurred during insertion or removal of the device. Three-month follow-up was completed in 33 patients (55 ostia), with 93 percent of the treated ostia remaining patent and seven percent that could not be visualized. No ostia were reported to be occluded. Fifteen percent of patients in the study were treated in an office setting after pre-procedural injection of anesthesia; no additional anesthesia or medication was required for these patients for the duration of the procedure. This is in contrast to balloon dilation devices, which often require administration of anxiolytics, analgesics and/or additional local injections of anesthetics during the procedure to increase patient tolerability. The remaining patients were treated in the operating room adjunctive to functional endoscopic sinus surgery (FESS). More information on the study can be found at http://sinusys.com/study/.