On 07-Apr-2020, Olympus announced the approval of its non-surgical medical device, iTind for the minimally invasive treatment of Benign Prostatic Hyperplasia (BPH). FDA has provided a De Novo classification for this product and classified it under Class II medical device category. It is a temporarily placed urethral opening system for symptoms of benign prostatic hyperplasia.
This iTind, a flexible three-strut nitinol device was developed by the Medi-Tate, an Israeli-based medical device manufacturer. The distribution of Medi-Tate products in US, including the iTind device, is handled by Olympus.
BPH, also called prostate enlargement, is a noncancerous increase in size of the prostate gland which is one of the most common diseases in aging men and the most common cause of lower urinary tract symptoms (LUTS). iTind is a prescription use device that is inserted transurethrally and deployed at the prostate. It is intended for the treatment of symptoms due to urinary outflow obstruction secondary to BPH in men. The implant is designed to increase prostatic urethral patency by increasing prostatic opening. It creates channels that allow urine to flow and reshape the prostate.
In a news release, Dr. Jed Kaminetsky, Clinical Assistant Professor at NYU Medical Centre and a Board Certified Urologist at University Urology in New York City said that “this 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”.
Reference:
1. https://www.accessdata.fda.gov/cdrh_docs/pdf19/DEN190020.pdf