Innovative Technology Leads a New Breakthrough in Minimally Invasive, No-Forbidden-Zone Treatment of Malignant Pulmonary Nodules
Recently, the team of the Department of Respiratory and Critical Care Medicine of Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine used our company’s independently developed Wknife product to successfully carry out the first batch of clinical trials of robotic bronchoscopy-guided steep pulse non-thermal selective ablation of malignant pulmonary nodules.
This clinical practice marks the first successful application in humans of an innovative treatment regimen that integrates cutting-edge robot-assisted precise navigation technology with Wknife’s core non-thermal physical ablation technology, achieving precise, minimally invasive, and selective ablation of lung lesions with coverage of the whole lung. This is not only a breakthrough advance in the application of a new technology in the field of minimally invasive pulmonary intervention, but also confirms our company’s R&D strength and technological leadership in the field of precise interventional treatment of early-stage malignant lung tumors.
This clinical trial used our company’s independently developed transbronchial Wknife ablation system. Wknife ablation technology is a cutting-edge innovative technology in the current field of minimally invasive diagnosis and treatment of pulmonary tumors. It guides a flexible catheter into the target area via bronchoscopy and releases broad-spectrum synergistic pulses through the electrode tip to induce irreversible electroporation and death of tumor cells. Its core advantage lies in its non-cold, non-thermal selective ablation principle, which, while ablating the lesion, can to the greatest extent protect the integrity of the ablation zone and adjacent important airways and blood vessels, significantly reducing damage to normal lung tissue. Compared with traditional cold and thermal ablation techniques and the percutaneous puncture route, it causes less trauma, fewer complications, and a shorter recovery period, and can be used for ablation of tumors at special sites such as near blood vessels, near the trachea, and the hilar region; moreover, the catheter has a smaller outer diameter, making it easier to reach some large-angle lesions and achieve access to the whole lung. This significantly improves safety, feasibility, and efficacy, providing a brand-new treatment pathway for patients with pulmonary nodules who have early-stage, high-risk, or special lesions, or who cannot tolerate conventional surgery.
At the same time, the transbronchial Wknife ablation system can integrate synchronous biopsy and a robotic bronchoscopy intelligent platform, combining navigation and 3D reconstruction technology and intelligent algorithms to form a one-stop integrated platform for precise diagnosis and treatment of pulmonary nodules, achieving access to and treatment of the whole lung.
The first batch of transbronchial pulmonary nodule ablation clinical trials, led by the respiratory intervention team of the Department of Respiratory and Critical Care Medicine of Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, treated a total of 3 patients with malignant pulmonary nodules, covering various complex scenarios such as the one-stop synchronous diagnosis and treatment mode and synchronous treatment of bilateral multiple pulmonary lesions, and involving lesions at special sites adjacent to blood vessels, the trachea, and large-angle apices of the right upper lobe. The clinical results showed:
Surgical success rate 100%;
Complete lesion ablation rate 100%;
No serious complications such as bleeding or pneumothorax occurred during or after the procedure;
The mean postoperative hospital stay of patients was only 3 days, with rapid recovery;
Immediate postoperative and one-month postoperative imaging follow-up confirmed that the ablation zone had clear boundaries, with complete coverage of tumor tissue and marked shrinkage and absorption, indicating significant efficacy.
Preoperative and Postoperative Images of the Patient
Taking the first patient as an example: a 56-year-old woman. Combined with the patient’s medical history and follow-up imaging, a mixed ground-glass nodule was found in the 2nd apical segment of the right upper lobe with surgical indications, and robot-navigation-guided one-stop precise synchronous biopsy and Wknife ablation treatment were then performed. During the procedure, the physician constructed a detailed 3D “digital map” of the lung from the patient’s CT data and planned the optimal surgical path; intraoperatively, under the precise control of the robotic system, after cryobiopsy, our company’s independently developed disposable flexible pulse catheter was advanced along the natural orifice through 8 generations of bronchi to reach the deep target lesion in both lungs for pulsed ablation treatment. A single pulse treatment session took only 5-10 minutes, and multiple bilateral lesions together took 1 hour and 10 minutes; postoperative imaging showed that both lesions were adequately ablated, completely covering the target nodules, with no complications such as pneumothorax or hemothorax. The patient was discharged smoothly without discomfort during follow-up, and the one-month postoperative follow-up results showed that the target lesions were completely covered and exhibited absorptive changes, with definite efficacy.
This clinical trial is both a successful practice of the one-stop diagnosis-and-treatment paradigm of “robotic intelligent navigation + synchronous real-time biopsy + Wknife precision ablation” and an innovative breakthrough of the Wknife ablation system in providing tumor treatment solutions, as well as a key milestone in its industrialization. Taking the successful completion of this clinical trial as a new starting point, our company will join hands with top clinical institutions to continuously deepen the clinical research, promotion, and application of transbronchial ablation technology, and is committed to providing safer, more efficient, and more minimally invasive lung tumor treatment solutions for the majority of patients.
winonco Medical Technology Co., Ltd. is a National High-Tech Enterprise driven by clinical needs to innovate medical technologies, focusing on the R&D, production, and sales of Class III active medical devices, aiming to provide the best medical solutions for clinical practice.
The company’s main business focuses primarily on the field of minimally invasive tumor ablation, with its entirely self-developed high-voltage pulsed electric field irreversible electroporation technology at its core, covering a multi-physics, multi-modality technology platform such as cryoablation, radiofrequency, microwave, and ultrasound, and developing internationally leading minimally invasive tumor ablation solutions. Its products cover the treatment of a variety of solid tumors, aiming to organically combine the latest minimally invasive medical technologies to offer patients the optimal treatment options.
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