CE Mark for SinuSys™ Vent-Os® Sinus Dilation System for Treatment of Frontal and Sphenoid Sinusitis

Describing itself as a sinus health company, SinuSys™ Corp., tells us it has gained CE mark approval for two new devices that will expand its portfolio of low-pressure, self-expanding dilation devices to treat frontal and sphenoid sinusitis, in addition to maxillary disease.

Background

Chronic sinusitis affects approximately eight 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 (FESS), which is conducted in a surgical suite under general anesthesia or IV sedation.

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 utilizes the body’s natural mucosal fluids to expand the insert before removal. In an office setting, patients are comfortably relocated to the waiting room between insertion and removal of the device.

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.

The Vent-Os Sinus Dilation System received the CE Mark for its maxillary system in 2012. The FDA has also 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. The company will be filing for FDA clearance of its frontal and sphenoid devices upon completion of a multi-center clinical study.

SinuSys says the CE Mark will enable it to bring the simplicity, patient tolerability and long-term patency of the maxillary system to the treatment of frontal and sphenoid sinus disease. The new devices will be immediately available in the European Union.

Physician comments

“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. “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.”

Company comments

“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 Chief Executive Officer 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.”

Source: SinuSys, Corp.

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