FDA has granted De Novo authorization to Medi-Tate’s benign prostatic hyperplasia (BPH) device, the agency said last week.
Medi-Tate, which Olympus has an option to buy, designed the iTind device to reshape the anatomy of the prostatic urethra, thereby enabling urine to flow.
In authorizing iTind, FDA created special controls to mitigate the risk of infection, adverse tissue reaction and other potential harms associated with the device.
Four-fifths of men develop BPH at some point in their lives. The prevalence of the condition, which is associated with frequent urination and other symptoms that adversely affect quality of life, has made it a focus area for the medtech industry. In 2018, Boston Scientific paid $306 million upfront to buy BPH player NxThera. Teleflex also bought its way into the field, paying $725 million upfront to acquire NeoTract and its fast-growing UroLift device.
Olympus made BPH a pillar of its strategic plan in 2016, leading it to invest in Israel’s Medi-Tate two years later. The 2018 agreement gave Olympus the right to distribute Medi-Tate’s products and an option to acquire the company outright.
At that time, iTind was already CE marked and available in Europe. Now, Medi-Tate has secured FDA clearance to sell the device in the U.S. FDA authorized the device under its De Novo pathway and put it in Class II.
The authorization clears iTind for use in the treatment of urinary obstruction in men with BPH. When inserted transurethrally and deployed at the prostate, the device expands and puts pressure on the surrounding tissue at certain points. The device is removed after five days and, if effective, leaves the patients with new, lasting channels through which urine can flow.
In a multi-site study that enrolled 81 patients, the second generation of the device was associated with a mean maximum urinary flow rate of 14.72 ml per second one year after treatment. The mean flow rate at baseline was 8.46 ml per second. At 12 months, two patients needed medical therapy for BPH and two more, or 2.4%, needed transurethral resection of the prostate.
A smaller, single-center study tracked improvements in flow rate and other variables out to three years after treatment.
Medi-Tate is continuing to run studies to build up the evidence base to support iTind. Last year, the company began a small study to validate the device’s mechanism of action using MRI.