iTind™ Procedure Available to More Patients through Extended Commercial Payer Coverage

Policy updates extend coverage to as many as 27 million enrollees nationwide

CENTER VALLEY, Pa., (April 16, 2024) – Olympus, a leading global medtech company providing innovative solutions for medical and surgical procedures, announced today positive changes to commercial payer policies covering patients who could benefit from the iTind™ procedure, a minimally invasive treatment for the lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH), also known as enlarged prostate. Most notably, Aetna,ⁱ a CVS Health company, updated its Clinical Policy Bulletin 0079 for Benign Prostatic Hyperplasia to include the iTind procedure as medically necessary in cases where the prostate volume is between 25 and 75 g, and there is a lack of obstruction in the median lobe. This policy update affects 25 million lives covered nationwide.¹

In addition, three regional health plans updated their policies. These positive policy updates affect approximately 2 million more lives across Delaware, Florida, North Carolina, Pennsylvania, South Carolina and Washington, DC.

The positive commercial payer policy changes remove barriers to access for physicians who recommend the iTind procedure to their BPH patients, as well as for patients seeking a proven alternative to more invasive treatment options or pharmaceuticals that may come with unwanted side effects. The policy updates increase the likelihood of the iTind procedure being covered by payers and fosters greater adoption by both patients and physicians seeking safe and effective treatment for BPH.

“We are very pleased to see these positive coverage updates for the iTind procedure,” said Paul Skodny, PharmD, Executive Director for Health Economics and Market Access at Olympus Corporation. “Olympus is committed to supporting physicians and patients in accessing recommended and proven BPH therapies like the iTind procedure.”

Clinical Evidence
Studies show the iTind procedure is proven to relieve LUTS symptoms secondary to BPH without affecting sexual and ejaculatory function^2,3,4 or urinary continence.³

Olympus UNITE Patient Access Program
Olympus UNITE assists patients in gaining access to new medical technologies, including the iTind™ procedure.

AUA Guidelines
The iTind procedure is included in the American Urological Association (AUA) clinical practice guideline for management of LUTS attributed to BPH. The iTind procedure is reflected in the new procedure category, Temporary Implanted Prostatic Devices (TIPD).⁵

The iTind™ procedure involves the placement of a temporarily implanted nitinol device that reshapes the prostatic urethra without burning or cutting out the prostate. The device can be placed in an outpatient setting or physician office. It remains in place for five to seven days while the patient is at home. Upon removal, patients experience rapid and effective relief of their symptoms. ^2,3,6

The iTind procedure may not be for everyone. Please consult with a doctor to see if the iTind procedure is right for you. As with any medical procedure, implantation of the iTind device comes with the possibility of side effects, including pelvic discomfort, blood in urine, and/or painful or urgent urination. In rare cases, the iTind device may cause urinary tract infection or a sudden difficulty to urinate.

More information about the iTind procedure is available at BPHTherapy.com/iTind.

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About Olympus
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 4,500 employees throughout locations in North and South America. For more information, visit olympusamerica.com.

ⁱ Trademarks and Service Marks are property of their respective owners and do not imply endorsement.

¹ Benign Prostatic Hyperplasia: Clinical Policy Bulletin. Aetna.com. https://www.aetna.com/cpb/medical/data/1_99/0079.html. Published March 20, 2024. Accessed April 1, 2024.

² Chughtai B, Elterman D, Shore N, et al. The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial [published online ahead of print, 2020 Dec 26].Urology. 2020;S0090-4295(20)31520-X. doi:10.1016/j.urology.2020.12.022

³ De Nunzio C, Cantiello F, Fiori C, et al. Urinary and sexual function after treatment with temporary implantable nitinol device (iTind) in men with LUTS: 6-month interim results of the MT-06-study. World J Urol. 2021;39(6):2037-2042. doi:10.1007/s00345-020-03418-2

⁴ Elterman D, Alshak M, Martinez Diaz S, et al. An Evaluation of Sexual Function in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia in Men Treated with the Temporarily Implanted Nitinol Device [published online ahead of print, 2022 Sep 7]. J Endourol. 2022; doi:10.1089/end.2022.0226

⁵ Sandhu, JS; Bixler, BR; Dahm, P; et al. Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH): AUA Guideline amendment 2023. Journal of Urology 2023

⁶ Amparore D, Fiori C, Valerio M, et al. 3-Year results following treatment with the second generation of the temporary implantable nitinol device in men with LUTS secondary to benign prostatic obstruction. Prostate Cancer Prostatic Dis. 2021;24(2):349-357. doi:10.1038/s41391-020-00281-5