|UroLift--Courtesy of NeoTract|
NeoTract touted study results in the official journal of The American Urological Association that the company claims show that its UroLift device enabling minimally invasive treatment for an enlarged prostate is safe and effective.
After three months, the 140-patient treatment group fared better than the control group 88% of the time, and two-year results showed a sustained therapeutic effect, NeoTract said. The study involved 206 patients in total. The peak urinary flow rate was increased by 4.2 mL per second when measured after three months and when measured after two years. After two years, only 7.5% of patients needed another procedure to relieve urinary tract symptoms, according to the release.
Finally, none of the patients reported de novo sustained ejaculatory or erectile dysfunction. The three-year study results will be presented at the annual conference of the American Urological Association in May.
|An illustration of UroLift implants securing the new position of the prostate to create a larger opening in the urethra--Courtesy of NeoTract|
NeoTract says the device is the only transprostatic implant system that does not involve cutting, heating or removing prostate tissue. It is performed as an outpatient procedure. In November 2014, the company announced Medicare reimbursement for the procedures from the federal Centers for Medicare & Medicaid Services.
During the surgery, the device is delivered endoscopically into the urethra, to the area blocked by the enlarged prostate, according to a company video. The obstructing prostate tissue on both sides of the passage is moved out of the way to create a larger urinary opening in the urethra. Using a 19-gauge needle, 4 to 5 implants are deployed to hold the prostate in the new position.
An enlarged prostate is also known as benign prostatic hyperplasia (BPH) and causes sleep and urinary problems. NeoTract says it affects 37 million men in the U.S., including 90% of men over 70. The side effects of medication to treat the condition can be overwhelming and include sexual dysfunction, dizziness and headaches, according to the release. Similarly, invasive surgery can result in permanent urinary incontinence, erectile dysfunction and retrograde ejaculation (dry orgasm).
The UroLift System received de novo approval from the FDA in September 2013. De novo approval is for low- to moderate-risk devices that do not have a substantially equivalent predicate device. Due to the product's novelty, the company pulled in $32.4 million in VC financing in the first half of 2012, making it one of the most heavily backed companies of the year.
- read the release
- here's the study abstract in Urology Practice