TECHNOLOGY

Sinusitis and Chronic Rhinosinusitis (CRS)

Sinusitis is an inflammation of the sinuses that causes pain, pressure and swelling of the air-filled spaces surrounding the nasal cavity. There are four (4) sinuses: the maxillary sinuses under the eyes; the frontal sinuses above the eyes; the ethmoid sinuses between the eyes; and the sphenoid sinus behind the eyes.

Chronic Rhinosinusitis (CRS) is defined as inflammation of the sinuses that persists longer than 12 weeks. Symptoms include pain and pressure above the eyes, along both sides of the nose and in the nose and throat. Patients suffering from chronic sinusitis often have fevers and difficulties with sleep due to congestion.

Causes: Many conditions contribute to the development of CRS. They include viral infections, asthma and allergies. These factors lead to a persistent inflammation of the sinuses that become unable to drain. The lack of aeration can then lead to serious complications including bacterial supra-infections or even the inflammation of neighboring anatomical structures.   

Burden of Disease: CRS ranks among the most costly healthcare conditions. In the US, estimates suggest that yearly CRS management costs are between $6.9 billion and $9.9 billion (Laryngoscope. 2015 Jul;125(7):1547-56). Due to the severity of the symptoms, refractory CRS has a significant impact on productivity (estimated $12.8 billion in annual societal productivity cost) and absenteeism (estimated at 24.6 to 38.8 working days/year)  (Laryngoscope. 2014 Sep; 124(9): 2007–2012).   

Current Therapeutic Options: The therapeutic goal is to free the airways and aerate the sinuses so that the inflammation can heal. Medical therapies include the use of nasal sprays and irrigation, and in a significant number of cases, surgery is required to free the airways.  Such surgeries are expensive and many times non-reversible.

THE SINOPSYS' SOLUTION

DISCLAIMER: The SLS stent is CE marked in Europe – and is NOT approved outside the EU.

(CAUTION:  Investigational device.  Limited by Federal (or United States) law to investigational use )

Sinopsys Lacrimal Stent (SLS)

In most CRS cases, the ethmoid sinuses are affected. SLS technology offers minimally invasive and direct access to the ethmoid sinuses.  The Sinopsys Lacrimal Stent will offer the first "top-down" treatment for CRS.

  

SLS has received CE mark for: “The design, development and manufacture of sterile, non-active, lacrimal-nasal or lacrimal-sinus implants, and sterile and non-sterile implant delivery instrument kits, used in the treatment of epiphora or rhinosinusitis”.

Sinopsys Lacrimal Stent

Key Features of SLS Technology

  • Simple and direct surgical access to the ethmoid sinus from the caruncle

  • Only surgical “top-down” procedure in which instrumentation points away from vulnerable anatomical structures

  • Immediate aeration of the ethmoid sinus to addresses potential anaerobic infections

  • Reversible procedure

The Procedure

© Sinopsys Surgical Inc. 2020