Olympus to Highlight Diverse Treatment Portfolio at American Urological Association Annual Meeting

Hands-on demonstrations will include the company’s first single-use flexible ureteroscope

CENTER VALLEY, Pa., (April 30, 2024) – Olympus, a global medical technology company committed to making people’s lives healthier, safer and more fulfilling, will highlight a diverse urology portfolio that can help physicians treat bladder cancer, urinary stones and enlarged prostate during this year’s American Urological Association (AUA) annual meeting May 3-6 in San Antonio.

Olympus will feature the recently FDA-cleared RenaFlex™ single-use flexible ureteroscope system, the company’s first single-use ureteroscope, and the ESG-410™ Surgical Energy Platform which supports procedural approaches and efficiencies in the treatment of NMIBC (non-muscle-invasive bladder cancer), benign prostatic hyperplasia (BPH), as well as a wide variety of open and laparoscopic procedures.

As the exclusive AUA2024 clinical practice guideline sponsor, Olympus will provide 2,500 copies of the AUA2024 Guidelines-At-A-Glance compendium books, which include the recommendation of Narrow Band Imaging™ (NBI™) technology for the diagnosis and treatment of NMIBC and the iTind™ procedure for the management of lower urinary tract symptoms attributed to BPH. The iTind procedure is reflected in the new procedure category, Temporary Implanted Prostatic Devices (TIPD).1

Stone management

The RenaFlex single-use flexible ureteroscope is intended to be used to visualize organs, cavities and canals in the urinary tract.2 It can also be used with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract. Visitors to the Olympus booth will have an opportunity for a hands-on skills challenge using the RenaFlex ureteroscope, which will be available in limited market launch in 2024.

The RenaFlex Single-use Ureteroscope works in combination with the compatible CV-S1 Video System Center for flexible single-use. For safe and proper use, follow the manufacturer’s instructions for use, handling, and operating of the RenaFlex Single-use Ureteroscope and the CV-S1 Video System Center. If used or handled in an improper manner, there is a risk of patient and/or operator injuries, burns, infections, bleeding, and/or perforation, and/or equipment damage.

The RenaFlex system is part of a larger stone management portfolio of products that allow physicians to confidently approach every patient or procedure at any site of care. Included in that portfolio is the SOLTIVE™ Premium SuperPulsed Laser System (SOLTIVE Laser System). The SOLTIVE System’s thulium fiber laser (TFL) technology allows physicians to dust kidney stones more quickly than advanced post-modulation Holmium:YAG technology.3 The SOLTIVE System will also be available for hands-on demonstrations.

The SOLTIVE SuperPulsed Laser, powered by a novel energy source, is capable of dusting stones in half the time and fragmenting stones relentlessly with virtually no retropulsion. For effective dusting and fragmentation, the tip of the laser fiber should be directly in contact with the stone. Continuous irrigation should be used to wash away stone fragments and to provide cooling of the treatment site. The use of higher power settings should be avoided, especially when the fiber tip is in close proximity to the ureteral wall, as perforation of the ureter may result.

As with non-laser surgery, the possibility of complications and adverse events, such as chills, fever, edema, hemorrhage, inflammation, tissue necrosis, or infection may occur following treatment. In extreme cases, death may occur due to procedural complications, concurrent illness, or laser application. As with any conventional surgery, acute pain may occur immediately following laser therapy and may persist for as long as 48 hours.4

Drs. Ahmed Ghazi and Naeem Bhojani will offer “Ask the Experts” lectures regarding their experiences with the SOLTIVE System along with a “Tech Talk” by Dr. Mantu Gupta, who will highlight the versatility of the laser platform.5

Bladder Cancer

The ESG-410 Surgical Energy Platform supports procedural approaches and efficiencies for the treatment of NMIBC. It is equipped with enhanced capacitors that allow for better plasma stability during ignition,6 and it powers the five modes of commonly used energy: monopolar, bipolar, advanced bipolar, ultrasonic and hybrid energy for use in endoscopic, laparoscopic and open procedures. The ESG-410 Surgical Energy Platform can be used in concert with Olympus’ NBI™ technology that enhances visual observation of mucosal and vascular patterns by utilizing specific blue and green wavelengths absorbed by hemoglobin.7 NBI is not intended to replace histopathological sampling as a means of diagnosis.

Recent data shows that the use of NBI™ technology with NMIBC patients led to a 37% less likelihood of recurrence over 12-35 months.8 Monitoring bladder cancer is critical. The American Cancer Society reports that bladder cancer has one of the highest recurrence rates9 with patients typically undergoing cystoscopy about every three months for years after treatment.10

BPH

Olympus offers a variety of minimally invasive and surgical treatment options to treat men with an enlarged prostate (BPH). The iTind™ procedure is a novel minimally invasive BPH treatment option that involves the placement of a temporarily implanted nitinol device that reshapes the prostatic urethra without burning or cutting out the prostate. It remains in place for five to seven days while the patient is at home. Upon physician removal, patients experience rapid and effective relief of their symptoms.11

The iTind device is indicated in men age 50 and above. Implantation of the iTind device may cause pelvic discomfort, blood in urine, painful or urgent urination. In rare cases, the iTind device may cause urinary tract infection or a sudden difficulty to urinate.

Olympus will host an iTind procedure “Tech Talk” to discuss how the iTind device was invented, how it works and which patients are ideal for treatment. Drs. Naveen Kella and Rahul Mehan will also offer “Ask the Experts” lectures in the Olympus booth regarding their experiences with the procedure.12

The ESG-410™ Surgical Energy Platform supports options for the treatment of BPH by providing an array of resection loops and vaporization buttons. The ESG-410 Surgical Energy Platform offers enhanced procedural efficiency in BPH resections due to faster tissue removal because of reliable ignition of larger resection loops.13

The ESG-410 electrosurgical generator, with its accessories and ancillary equipment, is intended for cutting and coagulation of tissue in open, laparoscopic and endoscopic surgery and should only be used by a qualified physician in an adequate medical environment. Improper use or use of incompatible equipment with this electrosurgical generator can lead to excessive or incorrect HF and cause thermal or other injuries for the patient and/or operator. All plugs must be securely inserted to the corresponding sockets for proper use. Be aware that if the main plug is accidentally disconnected during a procedure, the electrosurgical generator immediately turns off and this can result in complications for the patient. Please refer to the instructions for use prior to usage.

For more information about the urological portfolio, visit the Olympus booth, #311, during AUA or visit the RenaFlex™ system, ESG-410 Platform, SOLTIVE™ Laser System and iTind™ product pages for more information.

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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 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.

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.

1 Sandhu JS, Bixler BR, Dahm P, et al. « Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH): AUA Guideline amendment 2023.” J Urol. 2023;10. doi.org/10.1097/JU.0000000000003698

2 RenaFlex IFU

3 Benchmark study. Comparison of dusting and fragmenting using the new Super Pulse Thulium Fiber Laser to a 120W Holmium: YAG laser. AUA 2019. Dr. Ben Chew

4 For further information please refer to the SOLTIVETM Laser System IFU • PN001555 1_AE

5 Drs. Ahmed Ghazi, Naeem Bhojani and Mantu Gupta are paid consultants for Olympus Corporation of the Americas

6 When compared to the ESG-400 generator. Data on file 02/2023

7 Data on file with Olympus (D00489968)

8 Lai LY, Tafuri SM, Ginier EC, Herrel LA, Dahm P, Maisch P, Lane GI. “Narrow band imaging versus white light cystoscopy alone for transurethral resection of non-muscle invasive bladder cancer.” Cochrane Database Syst Rev. 2022 Apr 8;4(4):CD014887. doi: 10.1002/14651858.CD014887.pub2. PMID: 35393644; PMCID: PMC8990285

9 American Cancer Society, “Cancer Recurrence Rates.” Rev. December 2023

10 American Cancer Society, “Treatment of Bladder Cancer, by Stage.” Rev. December 2023

11 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.” Journal of Urology, pub. July 2021

12 Drs. Naveen Kella and Rahul Mehan are paid consultants for Olympus Corporation of the Americas

13 When compared with competitive generator. Data on file 02/2023