UPDATED: NeoTract's enlarged prostate implant gains FDA de novo nod

California's NeoTract won the FDA's sign-off for a permanent implant that helps older men with enlarged prostates urinate normally.

UroLift is designed to be used in men ages 50 and older who have an enlarged prostate (benign prostatic hyperplasia) and are enduring low or blocked urine flow because of it. The FDA noted it is the first permanent implant approved for its indication. Regulators gave UroLift a special de novo classification, something reserved for new devices that are low-to-moderate risk and don't have any market precedent.

U.S. regulatory approval adds to CE marking in place in Australia, Europe and Canada. But Dave Amerson, NeoTract's president and CEO, told FierceMedicalDevices that the U.S. regulatory nod opens up a number of new doors for the company.

"There are approximately 37 million men in the U.S. suffering from an enlarged prostate, and we are pleased to be able to work with the FDA to bring this product expeditiously to the U.S. market," he told us.

Amerson said that NeoTract plans a "selective introduction" of UroLift in the U.S as it simultaneously works on gradual expansion plans.

"We plan to work with key opinion leaders to ensure that the first series of cases go very well, while concurrently proceeding on the defined pathway to reimbursement to expand availability to patients throughout the United States," he said.

UroLift offers a potentially less-drastic treatment option than what is available now. Patients typically turn to drug therapy or surgery to remove the enlarged prostate section, the FDA noted, but those options can be more invasive. Meanwhile, a patient with enlarged prostate can end up with afflictions from urinary tract infections, to kidney stones and incontinence. The company notes on its website that UroLift is designed to open the urethra directly without needing a resection or tissue ablation.

Regulators said they gave UroLift their blessing, in part, based on two clinical studies of the suture-based system involving a combined 274 men ages 49 to 86. While the studies didn't produce serious problems, some patients did experience side effects, including pain or burning during urination. Others complained of having an urgent need to urinate, or being unable to completely empty their bladders. Overall, regulators said, UroLift was successfully inserted in 98% of patients.

NeoTract notes on its website that benign enlarged prostate affects 500 million-plus aging men around the world. NeoTract launched in 2004 and is based in Pleasanton, CA. It pulled in a reported $32.4 million in venture funding during the first half 2012, according to the National Venture Capital Association/PricewaterhouseCoopers MoneyTree report (based on Thomson Reuters data).

- read the FDA's release

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Editor's note: This story has been updated to include comments from NeoTract CEO Dave Amerson.