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FDA grants de Novo classification to iTind device for BPH

Olympus has announced the US Food and Drug Administration’s (FDA) de Novo classification of the non- surgical iTind device for the minimally invasive treatment of benign prostatic hyperplasia (BPH).

iTind was developed by Israeli-based medical device manufacturer Medi-Tate. Olympus holds the exclusive right to distribute Medi-Tate products in the US through an investment in the company.

Designed as a three-strut nitinol device, iTind can be placed during an in-office procedure. It expands over five days to generate channels that enable the urine to flow and reshape the prostate.

Olympus COO Nacho Abia said: “We are very excited to take the next step in making this new minimally invasive BPH treatment available to patients in the US and to offer physicians the ability to treat patients in office settings.

“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.”

BPH is considered to be the most common cause of lower urinary tract symptoms (LUTS). It is a common disease in ageing men. American Urological Association estimates that eight out of ten men will have BPH in their lifetime.

Commenting on the new development, Medi-Tate founder and CEO Ido Kilemnik said: “After over a decade in development and clinical trials, we are proud to bring this innovative and truly minimally invasive technology to the US market. 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.”

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