Johnson & Johnson MedTech Launches ETHICON™ 4000 Stapler, Strengthening Its Robotic Surgery Ecosystem

Jun 13, 2025 11:28 CST Updated 11:28

Johnson & Johnson

Medical Device R&D and Manufacturer

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June 10, 2025Johnson & Johnson MedTechAnnouncing the Launch in the United StatesETHICON™4000 Stapler, an advanced intraoperative stapling device equipped with proprietary 3D stapling technology (ETHICON 3D Reloads), aimed at enhancing the integrity of anastomotic lines in surgical procedures and reducing the risk of intraoperative complications such as leakage and bleeding. The product is suitable for both open surgery and laparoscopic surgery and is planned for future integration with technologies currently under development by Johnson & Johnson.OTTAVA Robotic Surgical SystemExclusive Compatibility.

In addition, Johnson & Johnson will hold on June 15-19, 2025.Annual Meeting of the American Society for Metabolic and Bariatric SurgeryShowcase ETHICON 4000 and its broader portfolio of surgical technologies to support bariatric surgery.

# Product Introduction

In Surgical OperationsAnastomotic Line Leakage and BleedingAre common complications, especially in complex tissues or high-risk surgeries. They may lead to postoperative infections, prolonged hospital stays, and increased medical costs. According to data from Johnson & Johnson Medical Technologies, the medical costs caused by these complications in the United States amount to a staggering figure each year.Approximately USD 3 billionMoreover, the differences in tissue thickness, elasticity, and blood supply among different patients and surgical scenarios place higher demands on anastomosis devices. The development goal of ETHICON 4000 is to address these priority surgical scenarios, reduce the risk of complications, and improve surgical outcomes.

ETHICON^™4000 Stapler is equipped withProprietary 3D Stapling Technology and Enhanced Gripping Surface Technology (GST), to distribute pressure more evenly and reduce potential leaks and bleeding. This stapler is associated with ETHICON^™3D Staple Cartridge for use, maintaining consistency from the first staple to the last through a redesigned end effector and simplified staple cartridge options, to reduce potential leak paths.

ETHICON^™The 3D stapling technology of the 4000 stapler allows for more even pressure distribution across the entire staple line, reducing staple line interventions caused by bleeding compared to traditional 2D staples.Decreased by 23%. In addition, the redesigned cartridge of this stapler continues to adopt the enhanced Gripping Surface Technology (GST), which has been optimized to stabilize tissue and reduce tissue slippage. The new advanced ETHICON stapling technology includesEnd Effector and Staple Cartridge, specifically designed for the future in OTTAVA^™Designed for use with robotic surgical systems.

Since 2017, ETHICON^™Surgical stapling devices show evidence related to improved clinical and economic outcomes in bariatric, thoracic, and colorectal surgeries across different tissue types, patient populations, and countries. ETHICON^™4000 Stapler and ETHICON^™3D Staple Cartridge on this basisProvide stapling with offset-closed staple legs to distribute compression more evenly across the staple line, improving staple line integrity, leak resistance, and hemostatic capability.。

Expert and Executive Evaluation

Dr. Kelvin D. Higa(A clinical surgery professor at the UCSF Fresno Medical Education Program) said: "The 3D anastomosis technology allows me to distribute pressure on the anastomosis line more evenly, maintaining higher consistency. As a surgeon, the technological advancements of ETHICON 4000 give me more confidence when dealing with complex tissues."
Hani Abouhalka(Chairman of the Johnson & Johnson Medical Technology Surgical Division) stated: "Building on our legacy of innovation and reliable performance in surgical instruments, we are introducing new solutions aimed at addressing some of the most common and costly surgical complications. As surgeons strive to meet the evolving needs of patients, surgical techniques must also keep pace. Through continuous innovation, Johnson & Johnson provides a consistent and reliable surgical experience for open surgery, minimally invasive surgery, and robotic surgery."

# OTTAVA Robotic Surgical System

ETHICON 4000 is designed to seamlessly integrate with the OTTAVA robotic surgical system being developed by Johnson & Johnson.OTTAVA Robotic Surgical SystemIt is an innovative surgical assistance device that combines the company's over 135 years of experience in the surgical field and integrates Ethicon professional instruments and a digital ecosystem. The design features of the system includeUnified Architecture, "Dual-action" Functionality, Ethicon Professional Instruments, Polyphonic Digital Ecosystem, Multi-specialty Applicability, Operating Room Adaptability, Space Optimization and Team Collaboration。

Unified Architecture DesignEnables OTTAVA to integrate four low-profile robotic arms onto a standard-sized operating table, achieving a "zero-footprint" design that optimizes the movement and collaboration of the surgical team. Compared with traditional robotic systems, OTTAVA's design is more adaptable to existing operating room environments, addressing issues not specifically designed for robotic surgery.
"Dual-motion" function allows the operating table and robotic arms to move synchronously., supports intraoperative patient positioning and multi-quadrant operations, improving surgical efficiency. The system is equipped with Ethicon brand professional surgical instruments, which have decades of innovation history in the field of minimally invasive surgery, providing excellent instrument-tissue and user-instrument interaction experience.
Polyphonic Digital EcosystemBy connecting surgical techniques, robotics, and software, it provides data-driven insights to support clinical decision-making, intraoperative learning, and team collaboration.
OTTAVA is designed for multipleSpecialized Soft Tissue Surgical Robot, suitable for various types of surgeries, including bariatric surgery, small bowel resection, hiatal hernia repair, etc., especially ideal for complex surgeries requiring multi-quadrant manipulation.
System SupportRobotic surgery, laparoscopic surgery, hybrid surgery, and open surgery, providing higher flexibility to accommodate the needs of different patients and the clinical approaches of surgeons.
Designed to provide more workspace for the surgical team, reduce obstruction of 360-degree patient access by robotic arms, and enhance collaboration efficiency in the operating room.

Research Data

OTTAVA is currently in the research and development and clinical trial stage. In November 2024, OTTAVA received approval from the U.S. Food and Drug Administration (FDA).Investigational Device Exemption (IDE), allowing clinical trials to be conducted in the United States.

In April 2025, Johnson & Johnson announced the completionThe First Batch of Clinical Trial Cases, performed by Dr. Erik Wilson from the University of Texas Health Science Center at Houston at Memorial Hermann-Texas Medical Center,Using OTTAVA for Roux-en-Y Gastric Bypass Surgery. This is OTTAVA'sFirst Clinical Application, marking its entry into the clinical validation phase. The trial aims to collect safety and efficacy data to support a De Novo authorization application for various surgical indications, with plans to cover general upper abdominal surgeries.

According to internal research by Johnson & Johnson, OTTAVA’s functions are considered to significantly reduce operation time and adapt to smaller operating room environments. The Ethicon instruments of OTTAVA showed in the study that they canReduced 23% Anastomotic Line Bleeding Interventions, indicating its potential in anastomotic line integrity and hemostatic effects, which may indirectly support OTTAVA's surgical performance.

# About Johnson & Johnson

Johnson & JohnsonIs a global healthcare company founded in 1886, headquartered in New Jersey, USA. In the first quarter financial report of 2025, the adjusted earnings per share (EPS) reached$2.77, an increase from $2.71 in the same period last year, and also higher than the market estimate of $2.60, pushing the company's stock price up by more than 1% in pre-market trading. Johnson & Johnson's first-quarter sales reached$21.89 billion, year-on-year growth2.4%, surpassing the market expectation of $21.58 billion.

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