Boston Scientific’s GreenLight XPS Laser Therapy System has received a nod of approval from NICE to treat enlarged prostate.
The agency estimates the device could save the UK’s National Health Service up to £3.2 million annually by treating an estimated 13,600 patients on an outpatient basis for benign prostatic hyperplasia (BPH) rather than the traditional surgical resection.
NICE’s approval was based on comparative data collected from a 291-patient, nine-country European study comparing the system to transurethral resection of the prostate (TURP).
There were fewer initial serious post-procedure complications and lower hospital readmissions with the GreenLight XPS, and outcomes were as effective as the current standard surgical treatment.
The guidance notes that there’s currently not enough evidence to support the use of the device in high-risk patients, recommending specialists collect information on outcomes if the device is used in this subset of patients. It also recommends that where GreenLight XPS is used, urology services should be redesigned to ensure day-case surgery is available.
Boston Scientific inherited GreenLight XPS system when it acquired American Medical Systems’ urology portfolio from Endo. The FDA-cleared system is designed to increase the power and area of a laser beam by 50 percnet and offer a wider tissue vaporization effect with consistent vaporization and coagulation.
Read NICE’s device guidance here: www.fdanews.com/06-17-16-NICEGreenLighXPS.pdf. — Joya Patel