Guanqiao Medical Successfully Completes Pivotal Clinical Trial for Pulmonary Artery Thrombectomy System
On December 25, 2023, the pulmonary artery embolectomy system project, independently developed by Beijing Guanqiao Medical Treatment Technology Co., Ltd. (hereinafter referred to as “Guanqiao Medical”), successfully completed enrollment of the final subject in its pre-market clinical trial.
This clinical trial involved the interventional treatment of acute pulmonary embolism in patients using the Shandong Province Pulmonary Artery Embolectomy System and Thrombus Aspiration Catheter, jointly conducted by Professor Qie Liangyi and Professor Cui Xiaopei from the Pulmonary Vascular Disease Team of the Department of Geriatrics at Qilu Hospital of Shandong University. The patient who received treatment was a 62-year-old male who presented to Qilu Hospital with chest tightness after exertion. Upon evaluation, the physicians suspected acute pulmonary embolism and immediately performed a computed tomography angiography (CTA) of the pulmonary arteries. The results revealed embolism in the main trunk of the right pulmonary artery and multiple branches of both pulmonary arteries. The pulmonary vascular team organized a case discussion, assessed the relevant surgical risks and prognosis, and formulated a treatment strategy. They decided to perform reperfusion interventional therapy, utilizing a combination of percutaneous pulmonary embolectomy and thrombus aspiration catheters for the interventional management of pulmonary embolism.
During the procedure, the physician advanced the thrombus aspiration catheter over the guidewire to the main right pulmonary artery and performed aspiration, removing a large amount of strip-like and chunky red thrombi. Subsequently, the pulmonary artery thrombectomy system was deployed within the residual thrombus mass; after capturing the residual emboli with its mesh basket stent, the system was retrieved into the aspiration catheter. Final angiography demonstrated patent pulmonary arterial blood flow.
The procedure was concluded after angiographic confirmation that the target for thrombus removal had been achieved. Postoperatively, the patient’s pulmonary artery pressure decreased significantly.
Preoperative Angiography
Release the Thrombectomy Stent
Postoperative Angiography
Extracted Thrombus
Throughout the trial, all metrics met the expected targets, fully validating the safety and efficacy of Guanqiao Medical’s Pulmonary Artery Embolectomy System. Furthermore, the system is characterized by its ease of operation, which not only significantly enhances procedural safety but also effectively reduces operative time. Patients treated with this technology achieved favorable postoperative outcomes.
The completion of this clinical trial marks the successful conclusion of the nationwide multicenter clinical study, and validates the significant clinical efficacy of the combined treatment using a domestically produced pulmonary artery embolectomy system and thrombus aspiration catheter for acute pulmonary embolism. This achievement is undoubtedly of great significance in advancing related medical technologies and improving the treatment of patients with acute pulmonary embolism.
M.D., Associate Chief Physician at Qilu Hospital of Shandong University. He serves as a Young Committee Member of the Chest Pain Branch of the China International Exchange and Promotive Association for Medical and Health Care, Vice Chairman of the Pulmonary Vascular Disease Prevention and Control Branch of the Shandong Public Health Association, Standing Committee Member of the Chronic Non-communicable Disease Prevention and Control Branch of the Shandong Preventive Medicine Association, Vice Chairman of the Pulmonary Vascular and Right Heart Disease Committee of the Shandong Cardiac Function Research Association, and Committee Member of the Structural Heart Disease Professional Committee of the Shandong Medical Doctor Association.
Primarily engaged in clinical, preventive, and basic research on cardiovascular diseases such as coronary heart disease, hypertension, heart failure, and pulmonary hypertension. Specializes in interventional therapies for coronary heart disease, pulmonary vascular disease, valvular heart disease, and congenital heart disease. Participated in four provincial- and ministerial-level research projects and published more than 10 papers in core journals both domestically and internationally. In 2013, participated in the first bioresorbable scaffold-based percutaneous coronary intervention in the province; in 2018, completed the first interventional treatment for a patient with chronic thromboembolic pulmonary hypertension in the province; in 2022, completed the first optical coherence tomography-guided interventional treatment for saphenous vein graft lesions in the province; and in 2023, participated in the first interventional treatment in China for restenosis following pulmonary artery replacement in a patient with Takayasu arteritis.
M.D., Associate Chief Physician and Assistant to the Director, Department of Geriatrics (Healthcare Division), Qilu Hospital of Shandong University; Associate Professor of Clinical Medicine, Shandong University; Master’s Supervisor. He also serves as a Young Committee Member of the Geriatrics Branch of the Chinese Medical Doctor Association, Vice Chairman of the Professional Committee on Pulmonary Vascular and Right Heart Diseases under the Shandong Provincial Research Association for Cardiac Function, and an Expert in the Health Category of the Shandong Provincial Popular Science Expert Talent Pool.
Specializes in the diagnosis and treatment of pulmonary vascular diseases, including various types of pulmonary hypertension and pulmonary embolism. Performed the first percutaneous transluminal pulmonary angioplasty for chronic thromboembolic pulmonary hypertension in Shandong Province, and established a pulmonary hypertension research cohort and multicenter collaborative network in the province. Principal investigator of one project funded by the National Natural Science Foundation of China, two projects funded by the Shandong Provincial Natural Science Foundation, and one key research and development project of Shandong Province. Authored more than 20 SCI-indexed papers, served as editor-in-chief of one monograph, and contributed as a co-author to three others.
Beijing Guanqiao Medical Treatment Technology Co., Ltd., established in 2020, is a leading innovative platform enterprise in China specializing in pulmonary vascular and respiratory interventions. Driven by product innovation and adhering to the philosophy of “treating patients’ needs as our own,” the company focuses on the research and development, manufacturing, sales, and service of pulmonary vascular devices. Its core founding team, with an average collaboration history of over 10 years, boasts extensive experience in obtaining regulatory approvals and commercializing products both domestically and internationally. With robust patent protection and distinctly differentiated products, the company targets the global market.