New BPH treatment, the iTind Device Receives FDA de Novo Classification Order for Benign Prostatic Hyperplasia (BPH) Non-Surgical Treatment Device
CENTER VALLEY, Pa., April 6, 2020 /PRNewswire/ — Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, announced today the FDA de Novo classification of the iTind device, a non-surgical device for the minimally invasive treatment of Benign Prostatic Hyperplasia (BPH). The iTind device was developed by the Israeli-based medical device manufacturer Medi-Tate.
BPH is one of the most common diseases in aging men and the most common cause of lower urinary tract symptoms (LUTS).i According to the American Urological Association, BPH is a condition that 8 out of 10 men will face in their lifetimes.ii Treatment with the iTind device is straight forward and avoids complications associated with prescription medications, surgery, or permanent implants. The flexible three-strut nitinol device, which can be placed during an in-office procedure, gently expands over five days to create channels that allow urine to flow and reshape the prostate.
“Based on my initial experience in clinical trials, I’m excited to be able to offer this new office-based procedure to treat men who are suffering from common symptoms of an enlarged prostate and want a solution that has been shown to not compromise sexual function,” said Dr. Jed Kaminetsky, Clinical Assistant Professor at NYU Medical Center and a Board Certified Urologist at University Urology in New York City.
i Lim KB. Epidemiology of clinical benign prostatic hyperplasia. Asian J Urol. 2017;4(3), 148–151. doi:10.1016/j.ajur.2017.06.004
ii Medical Student Curriculum: Benign Prostatic Hyperplasia (BPH). Auanet.org. https://www.auanet.org/education/auauniversity/medical-student-education/medical-student-curriculum/bph. Published May 2013, Updated July 2016. Accessed March 3, 2020.