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Olympus lands FDA de Novo approval for benign hyperplasia device

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Image from Olympus

Olympus (TYO:7733) announced today that it received FDA de Novo classification for its iTind non-surgical device for treating benign prostatic hyperplasia (BPH).

Israel-based medical device manufacturer Medi-Tate originally designed the iTind device. Olympus holds the exclusive right to distribute Medi-Tate products in the U.S. through a strategic investment.

The iTind is designed as a flexible, three-strut nitinol device that can be placed during an in-office procedure. It expands over five days to create channels for allowing urine to flow and reshaping the prostate. Medi-Tate’s device won CE Mark approval in Europe in 2012.

In a news release, certified urologist at New York’s University Urology Dr. Jed Kaminetsky said the office-based procedure can treat men who are suffering from common symptoms of an enlarged prostate and want a solution that has not been shown to compromise sexual function.

“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,” Olympus COO & Olympus Corporation of the Americas CEO Nacho Abia said in the release. “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.”

Added Medi-Tate founder & CEO Ido Kilemnik: “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.”

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