Teleflex (NYSE:TFX) said today that the FDA has granted the company an expanded indication for the use of its UroLift system to treat larger prostates, between 80cc and100cc.
UroLift is a minimally invasive, in-office treatment designed to provide rapid relief and recovery from the symptoms of benign prostatic hyperplasia (BPH), or enlarged prostate. Symptoms may include frequent urination and can cause loss of productivity, depression and decreased quality of life. If left untreated, the condition can worsen over time and cause permanent bladder damage.
UroLift permanent implants are delivered during a transurethral outpatient procedure to relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue.
“This new indication marks another exciting milestone for Teleflex and an opportunity for hundreds of thousands more men to benefit from the UroLift system and the durable and lasting relief it can provide from burdensome BPH symptoms,” said Dave Amerson, president of the Teleflex interventional urology business unit, in a news release. “Over 100,000 men have been treated with the UroLift system worldwide and now many more will be candidates.”
A retrospective real-world study of the outcomes for 1,413 patients who received the UroLift across 14 sites in North America and Australia revealed results consistent with those seen in previous clinical studies, according to Teleflex. Patients included those in retention, with large prostates and comorbidities such as diabetes and prostate cancer, not commonly seen in clinical trials.
TFX shares opened up 0.13% this morning, trading at $379.50.
