Intervastec™, a subsidiary of Endovastec™, has officially launched a clinical study of its independently developed Transjugular Intrahepatic Portosystemic Shunt (TIPS) Stent Graft System at Zhongshan Hospital of Fudan University (Zhongshan Hospital). The clinical study will be led by its principal investigator Zhiping Yan, who is the Director of the Department of Interventional Therapies at Zhongshan Hospital. Recently, the first pre-market clinical implantation of the TIPS Stent Graft System was successfully completed in Rui’an People's Hospital by Prof. Changsheng Shi and his interventional vascular surgery team.
The patient, a 41-year-old male, presented with a 3-year history of cirrhosis and was vomiting blood with black blood clots nine hours prior to the operation . Additionally, he presented with black stools without any obvious cause. A CTV examination of his portal vein suggested “cirrhosis, in-stent occlusion after portal shunt, marked dilatation of portal vein, splenic vein, splenic portal area, lower esophagus and perigastric vein”. Parallel TIPS surgery was proposed.
During the procedure, the patient was placed in a supine position and was cannulated through the right femoral artery under general anesthesia. The original shunt stent was determined to be occluded. Puncture was performed through the right jugular vein and under fluoroscopy through the right hepatic vein to the left branch of the portal vein to form a parallel shunt tract. An 8mm (diameter) by 70mm (length of the laminated segment) TIPS stent developed by Intervastec™ was implanted between the hepatic vein and portal vein. The patient experienced no discomfort during the procedure. The device was introduced and released in good shape and in a precise position, achieving the desired surgical result.
After the surgery, Prof. Changsheng Shi commented that for this particular case: “the TIPS Stent Graft System developed by Intervastec™ was introduced safely with stability, accurate positioning, no displacement and good release pattern. Stent release becomes more stable thanks to the unique method of pulling the outer sheath through joint shaft rotation on the conveyor.”
As the first product independently developed by Intervastec™ for treatment of portal hypertension and its complications, the TIPS Stent Graft System is expected to benefit more portal hypertension patients after its domestic launch. The TIPS Stent Graft System adopts the design of a covered cut stent combined with woven stent, providing good radial support and flexibility to maintain good stent shape and patency. At the same time, the use of a cut stent can improve blood flow and enhance the bypass effect of the stent. The method of pulling the outer sheath through joint shaft rotation on the conveyor to release the stent can ensure smoothness and convenience of the stent release process as well as precise stent positioning.
Founded in 2021 by Endovastec™, Intervastec™ is dedicated to the research and development of oncology interventional medical devices. Currently, in addition to the TIPS Stent Graft System, it has a number of innovative products in development. In the future, Intervastec™ will continue to launch more high-quality innovative products, continuously improve the composition of its product lines, enhance its competitiveness in the oncology interventional medical devices market, and benefit oncology patients worldwide.