NICE Provides Positive Guidance for Use of the XprESS Multi-Sinus Dilation System

Entellus Medical Inc. announced that the National Institute for Health and Care Excellence (NICE) Medical Technologies Advisory Committee provided positive guidance for use of the XprESS Multi-Sinus Dilation System (XprESS) for the treatment of chronic sinusitis after medical treatment has failed.
 
NICE provides evidenced-based guidance and advice for the National Health Service (NHS) in England and other public health and social care services to improve health and social care. The guidance helps people in the NHS make efficient, cost-effective and consistent decisions about adopting new products.
 
Following the examination of information submitted by Entellus Medical along with independently sourced clinical studies and expert advice, NICE’s Medical technologies guidance determined that treatment with XprESS leads to rapid and sustained improvement in chronic symptoms associated with sinusitis, fewer acute episodes and improved quality of life which is comparable to functional endoscopic sinus surgery (FESS). NICE recommends XprESS for use in patients with uncomplicated chronic sinusitis who do not have severe nasal polyposis. In these patients, NICE has asserted XprESS works as well as FESS, is associated with faster recovery times, and can more often be done under local anesthesia.
 
“This guidance further confirms that use of the XprESS Multi-Sinus Dilation System in an out-patient setting under local anesthetic offers an effective and cost saving alternative to the current standard of care,” said Robert White, president and CEO of Entellus Medical. “NICE is internationally recognized for its evidence-based review process. This guidance builds on their commitment to ensure that the NHS is able to adopt clinically and cost effective technologies to improve patient outcomes.”
 
The NICE guidance indicated that the XprESS Multi-Sinus Dilation System is cost saving compared to FESS based on device cost, length of FESS procedure and assuming the treatments are performed under local anesthetic in an outpatient setting. By adopting this technology, NICE estimates that NHS in England may save around 7.4 million British pounds a year by 2020. The estimated savings are largely achieved through the shift of treatment from the operating theatre to the outpatient setting. Additionally, the Medical Technologies Advisory Committee considered that XprESS has the potential to treat uncomplicated chronic sinusitis earlier in disease progression than is currently available in the NHS. As such, it may improve quality of life and clinical outcomes, as well as reduce surgical waiting lists. The NICE guidance is specific to the XprESS Multi-Sinus Dilation System and does not cover any other balloon sinus dilation technology.
 
Chronic rhinosinusitis (CRS) is a common disease worldwide, some estimates indicating that up to 16 percent of the population suffer from CRS, making it more prevalent than asthma or diabetes.  CRS has a negative impact on the quality of life with chronic symptoms and effects including facial pain and pressure, headaches, fatigue, loss of smell, and sinus infections.
 
Prior to the development of sinus balloon dilation technology, CRS treatment options included nasal saline irrigation, intranasal corticosteroids, systemic antibiotics or topical drops, and FESS. With the development of standalone sinus balloon technology, CRS can now be treated in the comfort and convenience of a physician’s office and in a manner that preserves the natural sinus anatomy. In-office balloon sinus dilation is a proven, effective alternative treatment to endoscopic sinus surgery and provides patients lasting relief at a lower cost than traditional sinus surgery.
 
Plymouth, Minn.-based Entellus Medical develops products designed for the minimally invasive treatment of chronic and recurrent sinusitis in both adult and pediatric patients. The Entellus Medical platform of products provides effective and easy-to-use solutions to simplify everything from diagnosis and patient selection, to complex case revisions and post-operative care. Entellus Medical’s three core product lines, XprESS Multi-Sinus Dilation Systems, MiniFESS Surgical Instruments, and FocESS Imaging & Navigation, combine to enable ENT physicians to conveniently and comfortably perform a broad range of procedures in the office and simplify OR based treatment. Entellus Medical is committed to broadening its product portfolios with high-quality and purposeful innovations for the global ENT market.