Optilume is a urethral balloon coated with paclitaxel (3.5 microgram/mm2). It is indicated for managing urethral stricture disease in 'adult males'. It is designed to be used as a drug-coated dilation balloon for a urethral stricture that is 3 cm or less in length.
Optilume is available in 6 sizes (3 cm and 5 cm length versions, both in 3 different diameters). It is passed over a guidewire under direct vision with or without fluoroscopy, and positioned along the length of the stricture. The balloon is then inflated with a provided pressure inflation device, using saline or water. The inflated device is kept in place for a minimum of 5 minutes, at the recommended pressure, to dilate the urethral stricture and allow uptake of paclitaxel. The pressure is measured in atmospheres, as per instructions for use.
Optilume urethral drug-coated balloon received a CE mark in September 2020 as a class 3 medical device.
Current treatment options for recurrent bulbar urethral strictures include endoscopic procedures, urethral dilatation, direct visual internal urethrotomy and urethroplasty. The choice of treatment is considered by a multidisciplinary team and is dependent on patient and clinician choice, and clinician expertise. People having urethroplasty in the UK have often had several previous endoscopic procedures.
Optilume is intended to be an additional option for treating recurrent strictures that could delay or prevent the need for the more invasive urethroplasty surgery.
Optilume combines balloon dilation of the urethra to widen the stricture with paclitaxel delivered to the tissue of the stricture. The aim of the paclitaxel is to prevent new tissue growth and reduce scar formation.
Optilume is intended as a second-line treatment for urethral strictures in people who have had at least 1 previous endoscopic procedure that has failed. The technology is used by trained consultants in urology, urology trainees and urology nurse specialists. It can be done using local anaesthesia as a day case or in an outpatient setting.
Optilume is a single use device and costs £1,350 per unit (excluding VAT).
More details about Optilume are available on the company's website.