May 12 2022
Redwood City, CA – May 12, 2022 – Auris Health, Inc., a subsidiary of Ethicon, Inc,a Johnson & Johnson MedTech company,* today announces four scientific abstract presentations to be delivered at the upcoming annual American Urological Association (AUA) meeting May 13-16, 2022 in New Orleans, LA. This is the first time endourology data will be presented on the MONARCHⓇ Platform, Urology a flexible robotic solution that enables urologists to reach and visualize areas within the kidney with precision and control.
The MONARCH endoscopic robotic platform is now the first and only multispecialty, flexible robotic solution FDA cleared for use in both bronchoscopy and urology. MONARCH® Platform, Urology is a single platform to support both ureteroscopy (URS) and percutaneous nephrolithotomy (PCNL) procedures.
One of the studies to be featured in a podium presentation compared the use of the MONARCH robotic system for urology to the use of conventional devices for URS and PCNL in a porcine model.
“Kidney stones can be incredibly painful and debilitating for patients, and surgery remains the primary care. In working with the Monarch Team on the evolution of urological care in this area, we are striving to make these surgeries more precise and easier to perform, enhancing the available standard of care for our patients,” said Investigator Thomas Chi, MD, Department of Urology, University of California San Francisco.
In another podium presentation, a different study to be presented evaluated radiation exposure of urologists while gaining percutaneous access in a cadaveric model, using either standard-of-care fluoroscopy or an electromagnetic method with the MONARCH robotic system for urology. In addition, Mitchell Humphreys, MD, Department of Urology at Mayo Clinic in Arizona, will also present two posters focusing on urologists’ ability to use MONARCH® Platform, Urology when performing percutaneous access. Most urologists1 in the USA today rely on an interventional radiologist to perform percutaneous access for stone cases.
“We are pleased to share this data of the MONARCH® Platform, Urology with the AUA community, and we appreciate the collaboration with our clinical investigators who helped design and complete these first studies which demonstrate the ability for urologists to use MONARCH for reaching and visualizing areas within the kidney with precision and control,” said Raymond Fryrear, MD Ethicon Global Head Preclinical, Clinical and Medical Affairs for Robotics & Digital Solutions.
For the full list of abstracts, presentation details and more information, visit https://www.eventscribe.net/2022/AUA2022/.
Ethicon, a Johnson & Johnson MedTech company, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world’s most pressing health care issues and improve and save more lives. Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.
ABOUT JOHNSON & JOHNSON MEDTECH
At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopedics, vision and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive and more personalized.
*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC, Auris Health, Inc., and certain of their affiliates. All other trademarks are the property of their respective owners.
**Comprising the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s MedTech segment.
CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding MONARCH®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon, any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.
1 Metzler, I. S., Holt, S., & Harper, J.; Surgical Trends in Nephrolithiasis: Increasing De Novo Renal Access by Urologists for Percutaneous Nephrolithotomy. Journal of Endourology. 2021; 35(6): 769-774
Bronchoscopy Important Safety Statement:
Complications from bronchoscopy are rare and most often minor, but if they occur, may include breathing difficulty, vocal cord spasm, hoarseness, slight fever, vomiting, dizziness, bronchial spasm, infection, low blood oxygen, bleeding from biopsied site, or an allergic reaction to medications. Only rarely do patients experience other more serious complications (for example, collapsed lung, respiratory failure, heart attack and/or cardiac arrhythmia).
Urology Important Safety Statement:
Adverse effects from both Mini-PCNL and Ureteroscopy include pain, urinary tract infection, fever, hematuria (presence of blood in urine), exposure to low levels of radiation, retained or residual stones.
Adverse effects from ureteroscopy may include pain, perforation or injury to the ureter, resulting in extravasation of fluid and urine (urinoma), stricture of the ureter with risk of subsequent obstruction (hydronephrosis needing further repair), rare avulsion of the ureter, urinary blood clots, residual stones.
PCNL access may result in minor and major adverse effects. Minor effects include fever and nephrostomy leak. Major adverse effects may include injuries to pleura, liver, spleen, large vessels with related bleeding, gallbladder, duodenum, jejunum, colon with related cutaneous fistula, fever, pain, ileus, elevated counts.
Major adverse effects related to stone removal may include infection and urosepsis, intravascular fluid overload, extravasation of fluid, and post percutaneous nephrolithotomy bleeding.