It’s the 2014 Combined Otolaryngology Spring Meetings (COSM) in Las Vegas this week, and event that has seen the presentation of new data on the SinuSys™ the Vent-Os™ Sinus Dilation System. Six month clinical study results demonstrated sustained patency of the maxillary sinus ostia at six months.
When it comes to sinus dilation, the Vent-Os system is primarily up against balloon-based devices such as Entellus’ offering covered recently on our pages. Unlike the balloon method, that use rapid, high-pressure inflation, the Vent-Os Sinus Dilation System is a small, low-pressure, self-expanding insert designed to gently and gradually open the maxillary ostia. The system incorporates the Company’s proprietary osmotic technology, which utilizes the body’s natural mucosal fluids to expand the insert before removal.
In January 2014 we covered the news that the U.S. FDA had cleared the Vent-Os system for marketing, based to a degree on favourable results from the company’s then fifteen patient study. Now we’re up to 34 chronic rhinosinusitis (CRS) patients, treated at five sites, either as a stand-alone procedure or in conjunction with endoscopic sinus surgery. The Vent-Os device was inserted into the maxillary sinus opening at the beginning of the procedure and removed after 60 minutes.
In the patient set, 57 sinus ostia were accessed and successfully dilated. There were no device-related adverse events. At six months, 30 patients with 49 treated ostia were available for evaluation, with 92 percent of ostia (45) visibly patent and eight percent (4) unable to be visualized. All ostia were clinically functional. One patient (3.3 percent) developed sinusitis and was successfully treated medically.
The Vent-Os System enables low-pressure, gradual dilation of the maxillary sinus ostia in a simple, two-step interventional procedure, which is intended to maximize patient tolerability in an office setting under local anesthesia. This is borne out by 15 percent of patients in the study who were treated in an office setting after pre-procedural injection of anesthesia. Unlike balloon dilation devices, no additional anesthesia or medication was required for the procedure to increase patient tolerability. The remaining patients were treated in the operating room adjunctive to functional endoscopic sinus surgery.
“These clinical results demonstrate that a self-expanding, low-pressure dilator can provide durable patency of the maxillary sinus ostia in sinusitis patients,” said Peter J. Catalano, MD, FACS, Chief of Otolaryngology, St. Elizabeth’s Medical Center, Boston, MA, and a clinical investigator for the study. “The simplicity and tolerability of the Vent-Os procedure make it a viable option for both early-stage chronic sinusitis patients who have failed medical therapy and patients suffering from recurrent acute sinusitis. In this latter group, restoration of maxillary ventilation and drainage can provide relief without the long-term costs and risks associated with repetitive use of antibiotics and steroids.”
Source: SinuSys Corporation