Non-surgical Device for BPH Wins De Novo from FDA

Or Akiva, Israel-based Medi-Tate developed the iTind device. However, Olympus holds the exclusive right to distribute the device in the U.S.

Omar Ford

April 6, 2020

1 Min Read
Non-surgical Device for BPH Wins De Novo from FDA
Image from Adobe Stock

FDA has granted de novo classification to a non-surgical device for the minimally invasive treatment of Benign Prostatic Hyperplasia (BPH). The iTind device was developed by Or Akiva, Israel-based Medi-Tate. However, Olympus holds the exclusive right to distribute iTind in the U.S.

Here’s how iTind works. The flexible three-strut nitinol device can be placed during an in-office procedure. It expands over five days to create channels that allow urine to flow and reshape the prostate.

In a release, Nacho Abia, COO of Olympus Corporation and CEO of Olympus Corporation of the Americas said, "Our investment in Medi-Tate expands our patient care offerings in BPH, adding to our market-leading plasma resection portfolio for Transurethral resection of the prostate. 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 the quality of life for patients."

The American Urological Association said that eight out of 10 men will suffer from BPH in their lifetimes. Boston Scientific took a huge dive into the space a couple of years ago when it announced it would acquire NxThera for about $406 million. NxThera developed the Rezūm system, a technology that uses water vapor to remove excess prostate tissue thereby alleviating obstruction to flow, which helps reduce BPH-related symptoms.

Marlborough, MA-based Boston Scientific would continue to build out its urology offerings with the acquisition of Augmenix shortly after the NxThera deal. Augmenix developed the SpaceOAR hydrogel, which is injected before radiation therapy to create additional space between the rectum and prostate during treatment, thereby reducing rectal radiation dose and associated side effects.

About the Author(s)

Omar Ford

Omar Ford is MD+DI's Editor-in-Chief. You can reach him at [email protected].


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