 |
| Vent-Os System--Courtesy of SinuSys |
A device developed by Palo Alto, CA-based SinuSys that can be implanted during a simple office procedure may help patients breathe better and eliminate the need for sinus surgery.
The company's Vent-Os Sinus Dilation System keeps the largest nasal cavity, called the maxillary sinus ostia, open and free of obstruction for 6 months, according to new results from a clinical study presented at the Combined Otolaryngology Spring Meetings in Las Vegas.
The study results could help the company tap into a market of an estimated 28.5 million Americans with diagnosed sinusitis and provide an alternative to surgery.
Unlike balloon dilation devices that use rapid, high-pressure inflation, the Vent-Os System gradually dilates the opening that connects a sinus to the nasal cavity with low pressure using a two-step interventional procedure. The self-expanding insert is designed to gently and gradually open the maxillary ostia. The procedure is conducted in an office setting under local anesthesia.
The study included results from 34 chronic rhinosinusitis patients that were treated at 5 sites, either as a stand-alone procedure or in conjunction with endoscopic sinus surgery, which removes blockages in the sinuses. 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 group, 57 sinus ostia were accessed and successfully dilated. After 6 months, 30 patients with 49 treated ostia were evaluated, and investigators found that all ostia were functioning properly. There were no device-related adverse events.
"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," said Dr. Peter Catalano, chief of otolaryngology at St. Elizabeth's Medical Center in Boston and a clinical investigator for the study, in a statement.
The FDA has cleared the Vent-Os Sinus Dilation System in the U.S. for dilation of the maxillary sinus ostia and associated nasal spaces in adults.
- read the press release