How Sinuwave Works
The Sinuwave™ Photodisinfection System is an Easy-to-Use Effective Technology for CRS Infections
The Sinuwave™ Photodisinfection System is based on antimicrobial photodynamic therapy (aPDT), a technique relying upon activation of a well-tolerated topical photosensitizer solution via safe levels of laser light. The sensitizer, a formulation containing ultra-pure Methylene Blue (MeBlue), is irrigated via custom coaxial irrigation catheter onto the inflamed tissues of the paranasal sinuses. The sensitizer then selectively attaches to pathogens colonizing these surfaces. The activating light is painlessly delivered to the treated surfaces via a custom balloon catheter. In only a few minutes, the aPDT process:
- Destroys multidrug-resistant multi-species biofilms present on the sinus mucosa;
- Effectively and rapidly eliminates planktonic forms of bacteria, fungi and viruses that may be present;
- Eliminates local exotoxins such as protease;
- Significantly depresses the local inflammatory response;
- Enhances neutrophil activation;
- Vasoconstricts the tissues (providing an immediate sense of relief to the patient);
- Produces longer term (up to 6 months) suppression of circulating acute-phase proteins such as CRP;
- Causes no damage to the sinus epithelium or cilia.
This non-antibiotic, broad spectrum approach has been demonstrated to reduce CRS-causing antibiotic resistant polymicrobial biofilms by >99.9% after a single treatment. The treatment is target-specific to only those pathogenic organisms that have absorbed the photosensitizer and are exposed to a specific wavelength of light. aPDT is equally effective against normal strains and antibiotic-resistant strains of bacteria. Furthermore, there is no evidence of bacterial “photoresistance” occurring after repeated aPDT treatment cycles. The photodynamic mechanism of bacterial and fungal cell destruction involves perforation of the cell membrane or wall by aPDT-induced singlet oxygen and oxygen radicals, causing cellular damage, membrane lysis, protein inactivation and induction of cell death. The aPDT antimicrobial mechanism is therefore completely different from that of oral antibiotics and does not engage the same types of resistance mechanisms.
The Sinuwave™ Photodisinfection System is comprised of a Laser Light Source, Light Delivery Balloon Catheter, Siniss Spray Irrigation Catheter (Siniss) and prefilled Photosensitizer cartridge. The Spray/Irrigation Catheter is used to irrigate the sinus with saline to prepare the sinus for aPDT by flushing and removing excess mucus and debris from the cavity, followed by uniform irrigation of the mucosal surfaces with a fine spray of MeBlue photosensitizer solution. The Light Delivery Balloon Catheter delivers light to the sensitized sinus cavity, in order to activate MeBlue and produce the disinfection effect. There are no metabolic or thermal effects involved with this minimally invasive, localized therapy.