Boston Scientific enlarged prostate treatment gets NICE endorsement

The GreenLight XPS Laser Therapy System--Courtesy of Boston Scientific

Boston Scientific ($BSX) has received positive guidance from the National Institute for Health and Care Excellence (NICE) in support of the use of its GreenLight XPS Laser Therapy System to treat an enlarged prostate. The agency estimated that use of the system could save the U.K.'s National Health Service (NHS) up to £3.2 million annually by enabling an outpatient procedure for benign prostatic hyperplasia (BPH) rather than the traditional surgical resection.

An organization in support of outpatient procedures, the British Association for Day Case Surgery, has advocated for more than 90% of urological surgery being performed on an outpatient basis within the next 5 years.

Boston Scientific gained the GreenLight XPS system in its acquisition of the American Medical Systems urology portfolio from Endo ($ENDP) for up to $1.65 billion. The system is CE-marked and FDA-cleared; it is designed to increase the power and area of a laser beam by 50% and offer a wider tissue vaporization effect with consistent vaporization and coagulation.

"The GreenLight XPS System is a well-established treatment to help men with BPH," said Dr. Gordon Muir, consultant urological surgeon to King's College Hospital, London in England, in a statement. "It is suitable for almost all men, even those who may not be deemed fit for conventional surgery. The positive guidance from NICE will give more men access to the GreenLight XPS System and may allow surgeons to treat patients on an outpatient basis, with excellent outcomes and with fewer complications."

The GreenLight XPS Laser Therapy System--Courtesy of Boston Scientific

The NICE guidance was based on data including a 291-patient, 9-country European study comparing the system to transurethral resection of the prostate (TURP). The study found that the GreenLight XPS approach resulted in fewer initial serious post-procedure complications with lower hospital readmissions and outcomes as effective as the current standard surgical treatment, the company said.

The guidance recommends the treatment specifically for men who aren't at high risk of complications--those who don't have an increased risk of bleeding, whose prostates are smaller than 100 ml, and who don't have urinary retention. The agency estimated that about 13,600 men annually could benefit from NHS treatment with the device.

"Whilst benign enlarged prostates may not be life threatening, the condition can impact on men's lives significantly. A procedure to reduce the amount of excess prostate tissue can improve the quality of life for men," said the director of the NICE Centre for Health Technology Evaluation Carole Longson.

"Using the GreenLight XPS is more convenient for patients than other surgical procedures as they don't need to stay in the hospital overnight and they can return to normal activity faster. We recommend that specialists collaborate to collect and publish data if GreenLight XPS is used in treating enlarged prostates in men classed as high risk," she concluded. "This will help improve the evidence base and could enable future recommendations on its use in these patients."

- here is the NICE statement
- and here is the announcement from Boston Scientific