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Global Debut: World’s First TroClose 2.0 Clinically Dispatched in China, Multi-Center Clinical Demonstration Officially Launched

2026-06-29
39次

March 30 — The world's pioneering Class III minimally invasive medical device—the disposable laparoscopic access and closure system, TroClose1200 2.0—successfully made its clinical debut in China. Leveraging this cutting-edge device, clinical experts at Shandong University Qilu Hospital (Qingdao) successfully performed surgery on a patient with adenomyosis. This marks the first clinical application of the device nationwide, signifying that this internationally leading Class III device has officially transitioned into the clinical application phase.

Following the procedure, the expert team at Qilu Hospital noted that while laparoscopic surgery is standard for common benign gynecological conditions like adenomyosis, traditional port-site closure remains complex and carries a heightened risk of tissue damage.

The clinical application of TroClose 2.0 offers far more than just a trocar with closure functionality; it introduces an entirely new surgical philosophy:

"If a complication persists over the long term, it may not be due to a lack of physician caution, but rather because the system itself failed to engineer a foolproof path toward the 'correct outcome.' Tools like TroClose 2.0 re-engineer that path."

The patient's post-operative feedback further validated the device's efficacy. Utilizing a standard 0–100 Clinical Pain Index, the patient reported a pain score of only 30, directly substantiating TroClose 2.0’s exceptional performance in reducing wound tension and mitigating post-operative pain.

From Israeli Innovation to Chinese Localization

TroClose 2.0 originated from advanced Israeli technology imported by Lujen Technology. The 1.0 generation of the device secured both FDA clearance and CE marking in 2016, supported by a global patent portfolio and a proven track record of over 3,000 successful clinical cases across Europe and the United States.

Upon its introduction to China, the Lujen team meticulously optimized the manufacturing and engineering processes. Today, the upgraded 2.0 iteration has secured US FDA clearance and successfully achieved localized manufacturing in China. This debut marks its official rollout into China's domestic clinical landscape.

The success of this maiden procedure not only underscores the clinical excellence of the Qilu Hospital medical team in the minimally invasive field, but also fully validates the unique technical advantages of TroClose 2.0:

  • Reduced Tension & Mitigated Pain: Maximizes patient comfort post-surgery.

  • One-Step Deployment & Precise Closure: Achieves a 0% incidence rate of incisional hernias.

  • Enhanced Efficiency & Safety: Streamlines the workflow, shortening surgical time by 15 to 20 minutes.

  • Short Learning Curve: Surgical teams can master the device's operational core in just 5 minutes.

Multi-Center Rollout Sweeps Nationwide

Following closely on the heels of the national debut, the First Affiliated Hospital of Chongqing Medical University officially initiated its TroClose 2.0 clinical demonstration on April 2. This rapid milestone marks the full-scale launch of the device’s multi-center clinical application network across China.

The technology transfer and localized production of TroClose 2.0 represent more than a mere equipment upgrade—it is a revolution in minimally invasive philosophy. The next evolution of laparoscopic surgery may not stem from overly complex energy devices or robotic systems, but rather from a rigorous, re-examined commitment to these long-overlooked procedural details.

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