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April 7, 2020

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).

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).

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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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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
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