Probranch® TIPS Venous Covered Stent Achieves First-in-China Successful Implantation in Pivotal Clinical Trial at Zhongda Hospital, Southeast University

At 8:00 a.m. on July 25, the interventional operating room on the seventh floor of Building No. 2 at Zhongda Hospital Affiliated to Southeast University was bustling with activity. An interventional procedure for portal hypertension involving the implantation of a TIPS stent, performed by Academician Teng Gaojun—President of Zhongda Hospital Affiliated to Southeast University and Director of the Interventional Diagnosis and Treatment Center—along with Deputy Director Zhang Qi and other team members, marked the successful completion of the first interventional surgery using a domestically produced covered TIPS venous stent for the treatment of portal hypertension and its related complications. This successful implantation also signifies that TIPS surgical treatment in China has entered a new era of domestic innovation.

According to reports, the first clinical trial patient was a 35-year-old female diagnosed with liver cirrhosis, splenomegaly, and esophagogastric varices. The main trunk, left branch, and right branch of the portal vein were slender, making puncture technically challenging. After multiple attempts, the puncture was successfully completed. Predilation was performed using a 6 mm balloon, followed by implantation of an 8 mm × 7 cm stent, and post-dilation with an 8 mm balloon. The stent delivery and deployment proceeded smoothly, with intact morphology and accurate positioning. The patient’s portal venous pressure decreased from 21 mmHg to 9 mmHg, successfully achieving the desired shunting effect.

This project is the first prospective, multicenter, single-arm, target-value clinical trial in China to evaluate the efficacy and safety of TIPS covered venous stents in the treatment of portal hypertension and its complications. The leading institution is Zhongda Hospital Southeast University, with collaborative participation from more than ten other research centers, including The First Affiliated Hospital, Zhejiang University School of Medicine; The First Affiliated Hospital of Soochow University; and Hunan Provincial People’s Hospital.

Portal hypertension is an inevitable consequence of liver cirrhosis once it progresses to a certain stage. At advanced stages, rupture of esophageal and gastric fundal varices can lead to massive upper gastrointestinal bleeding, triggering a series of complications such as hepatic encephalopathy, hepatorenal syndrome, and ascites. Transjugular Intrahepatic Portosystemic Shunt (TIPS) is an interventional treatment for portal hypertension. Compared with other surgical approaches, TIPS demonstrates a high success rate, with an effective hemostasis rate exceeding 90%. China has more than 7 million patients with liver cirrhosis, and the number continues to rise, with approximately 330,000 deaths annually attributed to portal hypertension related to liver cirrhosis.

Currently, all TIPS stents used by patients in China are imported products. Shanghai Hongpu Medical Device Co., Ltd. has developed the first Probranch, incorporating feedback from clinical experts and addressing the actual needs of domestic patients.^®This domestically produced stent, specifically designed for TIPS procedures, has achieved a breakthrough from zero to one for Chinese products. By innovatively combining heparin with the stent and offering a wider range of specifications, it better meets the needs of Chinese clinical patients and operators by improving long-term stent patency and enabling more rational control of the portosystemic pressure gradient.