iTind Device Receives FDA de Novo Classification Order for Benign Prostatic Hyperplasia: A Non-Surgical Treatment Device

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Olympus 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. Through an investment in Medi-Tate, Olympus holds the exclusive right to distribute Medi-Tate products, including the iTind device, in the U.S. This strategic investment, and the introduction to the U.S. market of this novel device strengthens the already robust Olympus urology portfolio by offering expanded options in enhanced patient care.

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.

For years Olympus has been an innovator in developing and marketing surgical treatment options for BPH, with electrodes for resection, vaporization and enucleation. With the recent FDA Classification Order of the iTind device, Olympus will continue to be a global market leader in men’s health.

“We are very excited to take the next step in making this new minimally invasive BPH treatment available to patients in the U.S. and to offer physicians the ability to treat patients in office settings,” said Nacho Abia, COO of Olympus Corporation and CEO of Olympus Corporation of the Americas. “Our investment in Medi-Tate expands our patient care offerings in BPH, adding to our market-leading plasma resection portfolio for TURP. The agreement supports one of the company’s key strategic initiatives to drive growth in our urology business and expand our minimally invasive surgical solutions. This will further enable Olympus to improve clinical outcomes, reduce overall costs and enhance quality of life for patients.”

“After over a decade in development and clinical trials, we are proud to bring this innovative and truly minimally invasive technology to the U.S. market,” said Ido Kilemnik, Founder and CEO of Medi-Tate. “We would like to thank the investors, clinical investigators, FDA de Novo team and all those who have contributed to making this platform such a success.”


References

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.

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