New Study Finds Powered Stapler Use Is Associated With Reduced Rates Of Bleeding Complications In Thoracic Surgery For Lung Cancer

SAN DIEGO, April 30, 2018 /PRNewswire/ -- Bleeding complications dropped by nearly half when surgeons used a powered stapler as opposed to a manual device in what researchers say is the first real-world assessment of the two technologies in video-assisted thoracoscopic surgery (VATS) for lung cancer.¹ The study, which appears in the peer-reviewed journal, Advances in Therapy, also found a nearly 10 percent reduction in total hospital costs and one day sooner discharge from the hospital associated with the powered-stapling procedures.¹

The study, "Impact of Powered and Tissue-Specific Endoscopic Stapling Technology on Clinical and Economic Outcomes of VATS Lobectomy Procedures" was funded by Ethicon*, part of the Johnson & Johnson Medical Devices Companies**, the market leader in powered staplers including ECHELON FLEX, one of the devices used in the study.

"This real-world study shows stapler choice really does matter in significantly reducing bleeding complications and lowering overall costs in VATS lobectomy procedures. The results in favor of powered stapling devices in thoracic surgery are compelling," said lead study author Daniel L. Miller, MD, Chief, General Thoracic Surgery at WellStar Health System, Mayo Clinic Care Network in Marietta, GA.

A lobectomy is a surgical procedure where an entire lobe of the lung is removed due to lung cancer, infection, chronic obstructive pulmonary disease (COPD) or benign tumors.² Between 2 and 10 percent of lobectomies result in bleeding complications.^3,4

In the study, VATS lobectomy patients, who were operated on primarily with ECHELON FLEX Powered Staplers, had nearly half the rate of hemostasis-related complications (8.5 percent vs.16 percent) of manual staplers and were hospitalized for estimated 4.9 days versus 5.9 days. Total adjusted hospital costs were about 9 percent more for procedures performed with manual staplers ($26,052 vs. $23,841). Outcomes including discharge status, operating room time and hospital readmissions were not different between the two groups.¹

For the study, researchers evaluated hospital discharge data of more than 3,550 thoracic patients from more than 700 hospitals that contribute to the Premier Healthcare Database, one of the largest statistically-certified hospital databases in the world. Patients had VATS lobectomy procedures with either powered staplers (659 patients) or manual staplers (3,100 patients) between January 2012 and September 2016. Of the powered staplers used in the study, over ninety-nine percent were ECHELON FLEX Powered Staplers, manufactured by Ethicon. Of the manual staplers used in this study, over seventy-five percent were manufactured by Medtronic, with the balance being manufactured by Ethicon.

In some cases, there were two ECHELON FLEX Powered Staplers used in the procedure versus one manual stapler. A sub-analysis of these cases found improved hemostasis outcomes were associated with use of ECHELON FLEX Powered Vascular Stapler plus another ECHELON FLEX Powered Stapler without increasing costs.⁵

Click to Tweet: Does Stapler Choice Matter in Thoracic Surgery? New evidence shows a possible connection between innovation and outcomes #AATS2018. Learn more at https://bit.ly/2jg6BpX

In addition to the ECHELON FLEX Powered Vascular Stapler, Ethicon's portfolio of thoracic procedural devices includes the ECHELON FLEX GST System, which controls tissue movement, and the HARMONIC HD1000i Shears, designed to address unique challenges in complex open and VATS procedures.

ECHELON FLEX Powered Staplers are tissue-specific devices designed to positively impact patient outcomes.⁶ ECHELON FLEX Powered Vascular Stapler's narrow anvil, increased articulation, and smaller shaft diameter improve access and enables more precise placement on fragile pulmonary vessels including VATS lobectomy for lung cancer.⁷

"We continue to take aim at critical clinical issues such as hemostasis complications through the development of innovative devices like ECHELON FLEX Powered Staplers and the generation of meaningful clinical and real-world evidence that fills knowledge gaps, validates outcomes and better informs everyday decision making," said Edmund Kassis, MD, Ethicon Sr. Medical Director for Thoracic Surgery.

Lung cancer is the second most common cancer in the US and is by far the leading cause of cancer death among both men and women. According to the American Cancer Society, there will be about 234,030 new cases of lung cancer (14% of new cancers) and about 154,050 deaths from the disease in 2018.⁸

About the Johnson & Johnson Medical Devices Companies
The Johnson & Johnson Medical Devices Companies' purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, interventional and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

About Ethicon
From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing healthcare 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 and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com, and follow us on Twitter @Ethicon.

*Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. Ethicon Endo-Surgery, Inc. is the legal manufacturer of ECHELON FLEX™ Powered Staplers. All other trademarks are the property of their respective owners.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, and interventional solutions businesses within Johnson & Johnson's Medical Devices segment.
^# All surgery presents risk. Please consult with your doctor.
^τ Dr. Daniel Miller is a consultant for Ethicon.

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¹ Miller DL, et al. Impact of powered and tissue-specific endoscopic stapling technology on clinical and economic outcomes of video-assisted thoracic surgery lobectomy procedures: a retrospective, observational study. In press February 13, 2018.
² http://www.lung.org/lung-health-and-diseases/lung-procedures-and-tests/lobectomy.html 
³ Kent M, et al. Open, video-assisted thoracic surgery, and robotic lobectomy: review of a national database. Ann Thorac Surg. 2014;97:236-444.
⁴ Based on Ethicon (2016) internal analysis of data from 26,955 lobectomy procedures captured in Premier Perspective database for the period of 2008-2014.
⁵ Ethicon retrospective analysis of outcomes between Echelon Powered vs. Medtronic non-powered endoscopic surgical staplers among patients undergoing video-assisted thoracoscopic surgery lobectomy.  Review of 1,051 cases between 2012 and 2015 from the Premier Hospital Database. Hemostasis-related complications:  4.8% vs 14.2%; p=0.010. Transfusion:  3.0% vs 9.4%; p=0.023. Total hospital cost:  $23,219 vs $25,207; p=0.242.
⁶ Ethicon retrospective analysis of clinical outcomes between Echelon Powered vs. Medtronic non-powered endoscopic surgical staplers among patients undergoing video-assisted thoracoscopic surgery lobectomy.  Review of cases from the Premier Hospital Database: Transfusion:  4.7% vs 9.3%; p=0.018. Hemostasis-related complications:  8.2% vs 13.9%; p=0.0218.
⁷ Compared to the Endo GIA™ Curved Tip Reload with Tri-Staple™ technology.   PVE35A, EGIA30CTAVM, and PSE45A articulation data from IFUs of each device.
⁸ https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/key-statistics.html

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the ECHELON FLEX Powered Vascular Stapler. 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: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; 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 31, 2017, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's subsequent Quarterly Reports on Form 10-Q and other 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. Neither Ethicon nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

©2018 Ethicon, Inc. 090557-180423

SOURCE Ethicon

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