Chronic rhinosinusitis (CRS) is a common severe inflammation of the paranasal sinuses, the cavities that produce the mucus necessary for the nasal passages to work effectively. CRS affects around 10% of the EU population and is similarly prevalent worldwide. This causes nasal blocks, headaches, fatigue, facial pain and toothache, and in some cases severe fevers. CRS patients are typically first treated with medications such as nasal steroids, decongestants, antihistamines, saline solutions and antibiotics. When the symptoms persist for more than 12 weeks, patients can experience debilitating side effects. In approximately 20% of cases, breathing becomes sufficiently impaired to warrant functional endoscopy sinus surgery (FESS, 835,000 annual procedures in the EU); needed to improve airflow as the only form of alternative treatment. FESS procedures, however, suffer from severe post-operative complications (bleeding, scarring, inflammation, adhesions, polyposis among others) and high failure rates. It is reported that 23 – 47% of patients require revision surgery due to the return of CRS symptoms following a sub-optimal healing process. There is currently no truly effective medical device to ensure a successful healing process for the benefit of patients and healthcare providers. STS Medical have developed ArchSinus, a novel nasal stent which can be positioned in the nasal cavity following FESS to keep the sinus passages open and allow successful healing. It is anticipated that ArchSinus will overcome the post-operative complications suffered by millions of FESS patients worldwide and substantially reduce the cost burden on healthcare providers by removing the requirement for revision surgeries. The objectives of the feasibility study were to evaluate technical and regulatory requirements for introduction of the device into the European market, identify and finalise an optimised value chain, and design the clinical validation activities including securing sites for a clinical trial. STS Medical’s overall objectives are to become the foremost global supplier of stent technologies for treatment of prevalent nasal conditions, significantly increasing quality of life for sufferers of allergic conditions across the EU and globe.
