Back in May we covered the six month outcomes from a study into the SinuSys Vent-Os™ Sinus Dilation System. Clinical study results demonstrated sustained patency of the maxillary sinus ostia at six months. Now sustained patency of the maxillary sinus ostia has been demonstrated at 12 months in clinical study results presented at the American Rhinologic Society Annual Meeting in Orlando, Florida.
The United States healthcare system currently spends more than $8 billion annually on improving the health of patients with sinus conditions. The majority of patients with chronic sinusitis are treated with oral antibiotics and/or nasal steroids, which can increase the risk of antibiotic resistance and cause unwanted side effects such as epistaxis (nose bleeds), nasal ulcers, and nasal and oral infections.
The most effective surgical treatment is Functional Endoscopic Sinus Surgery (FESS), which is conducted in a surgical suite under general anesthesia or IV sedation.
As a quick reminder about the SinuSys offering, 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. The system is a small, low-pressure, self-expanding insert designed to gently and gradually open the maxillary ostia. The Vent-Os System incorporates the Company’s proprietary osmotic technology, which utilizes the body’s natural mucosal fluids to expand the insert before removal. SinuSys says that in an office setting, patients can be comfortably relocated to the waiting room between insertion and removal of the device.
The clinical study encompassed 34 chronic rhinosinusitis (CRS) patients that were 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 12 months, 27 patients with 45 treated ostia were available for evaluation, with 93 percent of ostia (42) visibly patent and seven percent (3) unable to be visualized. All ostia were clinically functional.
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 the procedure to increase patient tolerability. The remaining patients were treated in the operating room adjunctive to functional endoscopic sinus surgery (FESS).
“The durable results for a self-expanding, low-pressure dilator are demonstrating that the Vent-Os device can be a viable and long term solution for sinusitis patients,” said Amin Javer, MD FRCSC FARS, Director of the St. Paul’s Sinus Centre and Associate Clinical Professor at the University of British Columbia and a clinical investigator for the study. “The simplicity and tolerability of the procedure make it suitable for both early-stage chronic sinusitis patients who have failed medical therapy and patients suffering from recurrent acute sinusitis. For this latter group, it enables them to avoid the long-term costs and risks associated with repetitive use of antibiotics and steroids in addressing their condition.”
The FDA has cleared the Vent-Os Sinus Dilation System in the U.S. for dilation of the maxillary sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures
Source: SinuSys, Inc.