Japanese nod for UroLift to treat BPHJanuary 14, 2019
UroLift System for the treatment of benign prostatic hyperplasia (BPH) has been granted approval for marketing in Japan.
NeoTract, a wholly owned subsidiary of Teleflex Incorporated focused on urology, has received Shonin approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan, the company announced.
The UroLift permanent implants, delivered during a minimally invasive transurethral outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue.
Clinical data from a pivotal 206-patient randomized controlled study showed that patients with enlarged prostate receiving UroLift implants reported rapid and durable symptomatic and urinary flow rate improvement without compromising sexual function.
NeoTract plans to focus on establishing reimbursement over the next 12-18 months, followed by a launch of the UroLift System in select academic medical centres to build strong initial clinical experiences, before a full commercial launch.