CE Mark Granted to SinuSys for New Indications for its Sinus Surgery Devices

SinuSys Corp. has received CE mark for two new devices that expand the company’s portfolio of low-pressure, self-expanding dilation devices to treat frontal and sphenoid sinusitis, in addition to maxillary disease. The new devices will be immediately available in the European Union.

“The Vent-Os system is easy to deploy and enables physicians to bring the benefits of minimally invasive sinus dilation to their patients in an office procedure that is highly tolerable under topical or local anesthesia,” said Hesham Saleh, MBBCh FRCS (ORL-HNS), consultant rhinologist and facial plastic surgeon at Charing Cross and Royal Brompton Hospitals, and honorary senior lecturer at the Imperial College of Medicine in London, the United Kingdom. “By adding devices for frontal and sphenoid disease, an expanded group of patients will be able to benefit from this simple, gentle procedure that is appropriate for both early stage chronic sinusitis patients who have failed medical therapy and patients suffering from recurrent acute sinusitis.”

In a prospective, multi-center clinical study, the Vent-Os Sinus Dilation System demonstrated the ability to maintain patent maxillary sinus ostia at 12 months in 93 percent of treated ostia, according to the company.

Unlike balloon dilation devices 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 sinus ostia. The Vent-Os System incorporates the company’s proprietary osmotic technology, which uses the body’s natural mucosal fluids to expand the insert before removal. In an office setting, patients are relocated to the waiting room between insertion and removal of the device.

“Our proprietary low-pressure, self-expanding technology has the potential for broad application in sinus disease, and we are pleased that we can now provide ENTs and their patients with effective, long term solutions for a variety of sinus anatomy,” said SinuSys CEO Tom Schreck. “We will be focused on bringing these broader benefits to physicians in the U.S., expanding utilization of our technology, and developing innovative, new therapies to address sinus disease that affects so many millions of people worldwide.”

The Vent-Os Sinus Dilation System received the CE mark for its maxillary system in 2012. The U.S. Food and Drug Administration (FDA) also has cleared the Vent-Os Sinus Dilation System for dilation of the maxillary sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures. The company will be filing for FDA clearance of its frontal and sphenoid devices upon completion of a multi-center clinical study.

According to figures cited by the company, chronic sinusitis affects approximately 8 percent of the adult population worldwide. 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 common surgical treatment for chronic sinusitis is functional endoscopic sinus surgery, which is conducted in a surgical suite under general anesthesia or IV sedation.

Palo Alto, Calif.-based SinuSys technologies are designed to be atraumatic, tissue-sparing and easy to use, potentially enabling clinicians to intervene at earlier stages of sinus disease.