2 The technology

Description of the technology

2.1 The XprESS multi‑sinus dilation system (XprESS, Entellus Medical) is a sterile, single‑use device for treating chronic sinusitis. The system comprises a balloon‑tipped device with a reshapeable end that is inserted through the nose into the maxillary, frontal or sphenoidal sinuses. XprESS also includes an inflation syringe, bending tool and 2 extension lines to provide irrigation. The balloon is manipulated into the bony sinus outflow tracts (ostia) and inflated with saline. This reshapes and opens the ostia by displacing adjacent bone and paranasal sinus structures allowing the sinuses to drain more effectively

2.2 The system is available in 3 variants, XprESS Ultra, LoProfile and Pro, which differ in the dimensions of the suction tip and the balloon diameter and length. All suction tips and balloon lengths are appropriate for treating all sinuses; selection is based on clinician preference. The XprESS device, inflation syringe and bending tool are included in all variants. The Ultra and LoProfile (the version currently sold in the UK) systems also include an integrated PathAssist LED light fibre, which is available as an add‑on for the Pro. XprESS can be used under local anaesthesia, once the surgeon has had sufficient experience of using the device.

2.3 According to the company's submission XprESS costs £900. The company informed the committee that a reduction to £820 is available for centres that order 50 or more units in a year.

2.4 The claimed benefits of XprESS in the case for adoption presented by the company are:

  • A minimally invasive alternative to functional endoscopic sinus surgery (FESS), offering equivalent efficacy and minimal acute inflammation while preserving more sinus tissue and mucosa.

  • Reduction in risks associated with general anaesthetic and fewer staff resources needed, because the procedure is done while the patient is awake and under local anaesthesia.

  • Faster recovery time with less nasal bleeding and a shorter duration of pain medication.

  • Improved patient comfort and tolerance compared with other balloon technologies because XprESS allows more control of device placement.

  • Easier to use than other balloon technologies, because XprESS is based on a sinus seeker and no guidewire is needed.

  • More accurate cannulation of the maximally ostium.

  • Reduction in theatre time compared with FESS.

  • Reduction in length of stay in hospital.

  • Reduction in duration of prescription pain medication.

  • Reduction in postoperative nasal bleeding visits.

  • Reduction in hospital readmissions.

  • Potentially fewer patients waiting 18 weeks or longer for ear, nose and throat (ENT) surgery.

Current management

2.5 Sinusitis (also known as rhinosinusitis and sinus infection) refers to inflammation (because of infection or irritation) of the mucosal lining of the sinuses. This causes an increase in mucus production and a reduction in mucus drainage if the inflamed swollen mucosa blocks the sinus ostia. Both acute and chronic sinusitis are defined by the presence of nasal blockage or nasal discharge, accompanied by facial pain or a loss of smell. Acute sinusitis refers to an episode of symptoms that resolves within 12 weeks. Recurrent acute sinusitis refers to multiple episodes of acute sinusitis, (usually considered to be 3 or more in a year) that are separated by validated, symptom‑free intervals. Chronic sinusitis refers to an episode of symptoms that lasts more than 12 weeks. Chronic sinusitis may sometimes be accompanied by nasal polyps. Sinusitis may be associated with the extension of inflammation outside the paranasal sinuses and nasal cavity and be accompanied by neurologic, ophthalmologic, or local soft tissue sequelae. Chronic sinusitis is regarded as uncomplicated if none of these are present.

2.6 Current treatment options for chronic sinusitis include nasal saline irrigation, intranasal corticosteroids, systemic antibiotics or topical drops, and FESS.

2.7 NICE's clinical knowledge summary on chronic sinusitis describes measures to relieve symptoms, particularly for acute exacerbations of chronic rhinosinusitis, that include analgesics for pain or fever, occasional intranasal decongestants and intranasal saline irrigation, and warm face packs. Patients should be offered advice about managing associated conditions (such as allergic rhinitis, asthma and dental infections), along with advice on smoking cessation and dental hygiene when appropriate. A short course of antibiotics may be prescribed for acute exacerbations, but longer‑term courses are not recommended without seeking specialist advice. A course of intranasal corticosteroids of up to 3 months may be considered, especially if there is a suspicion of an allergic cause (such as concomitant allergic rhinitis).

2.8 A patient should be admitted to hospital if chronic sinusitis is associated with a severe systemic infection, or a serious complication such as orbital or intracranial infection or inflammation. Referral to an ENT specialist should be considered for people with frequent recurrent episodes of acute sinusitis (for example more than 3 episodes requiring antibiotics in a year), unremitting or progressive facial pain (urgent referral for suspected malignancy), or nasal polyps that are causing significant nasal obstruction. Referral to an ENT specialist should also be considered if a person has taken intranasal corticosteroids for 3 months without effect.

2.9 FESS is the most common ENT surgery used to treat persistent and severe cases of chronic sinusitis. During FESS, the surgeon uses a magnifying endoscope inserted through the nostrils to identify and remove affected sinus tissue and bone. The aim is to clear the obstructed ostia and flush out infected material, but retain enough healthy tissue for normal nose and sinus function. FESS is usually done under general anaesthesia. Scarring and adhesions can occur as a result of FESS, which may need postoperative removal of tissue, blood and bone (debridement). Other more serious risks occasionally associated with FESS include intraorbital and intracranial complications.

2.10 NICE interventional procedure guidance on balloon catheter dilation of paranasal sinus ostia for chronic sinusitis concluded that the current evidence on the procedure's short‑term efficacy is adequate and raised no major safety concerns

  • National Institute for Health and Care Excellence (NICE)