Case sharing丨clinical application of SIS Staple Line Reinforcement in the Second Xiangya Hospital of Central South University

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Case: obese diabetic patient discharged 3 days after surgery

Operation mode: Sleeve gastrectomy combined with jejunoileal bypass (SG + JJB)

Surgical team: Liu Wei, director of the Department of Hepatobiliary and Pancreatic Surgery, the Second Xiangya Hospital, Central South University

 Intraoperative application

1. Sleeve gastrectomy

2. Jejunoileal bypass

Figure: Sleeve gastrectomy performed using a stapler loaded with SIS Staple Line Reinforcement

Figure: Demonstration of incisal edge during sleeve gastric surgery

Figure: Jejunoileal bypass performed using a stapler loaded with SIS Staple Line Reinforcement

 Figure: Demonstration of anastomosis after Jejunoileal bypass

Director Liu Wei team usage feedback:

1. Vidasis^® SIS Staple Line Reinforcement loaded on the anastomosis and fit well, and the loading process is smooth and easy to operate.

2. Before firing, the backing needs to be removed by drawing wire, which is easy to operate, and the backing is easy to be pulled out.

3. The intraoperative use is good. After firing, the anastomosis is well formed, and the resection margin and suture line have no obvious bleeding, No hand stitching for reinforcement.

4. Protect the anastomosis, and reduce the occurrence of bleeding and leakage. Avoid the damage caused by excessive suture and excessive embedding in the stomach.

5. It saves the operation time and reduces the patient expenses.

Liu Wei director pointed out, he had seen similar products in the United States, also looked for the product for a long time. He was happy to finally see the first domestic anastomosis reinforcement repair product listing, was satisfied with clinical application effect of the Vidasis® SIS Staple Line Reinforcement. Whether for doctors or patients, it was a very good product. He also recommended the product for clinical promotion and application. The SIS Staple Line Reinforcement is prepared by SIS material that can promote tissue regeneration. By promoting tissue regeneration and accelerating patient wound healing, the patient recovery will be paid attention to in the follow-up, and the product effect will be actually verified.

Vidasis® SIS Staple Line Reinforcement

Vidasis® SIS Staple Line Reinforcement, adopt SIS materials of Biosis Healing with independent intellectual property rights. In 2016, creative design and invention patent were launched, and clinical trial was launched in 2017, which was officially approved for the special approval process of innovative medical devices in 2018. In August 2022, the class III medical device registration certificate of National Medical Products Administration was officially obtained.

This product can be used with a stapler for strengthening the site of the anastomosis, and it is suitable for distal gastrectomy, proximal gastrectomy, sleeve gastrectomy, and gastrointestinal gastrostomy. The participating clinical centers include: West China Hospital of Sichuan University, Peking University Cancer Hospital, Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Zhongshan Hospital Affiliated to Fudan University, and Jiangsu Provincial People's Hospital.

Figure: The official website of the National Medical Products Administration

By searching the database of domestic devices of National Medical Products Administration, there are no domestic devices for the same expected purpose. Biosis Healing SIS Staple Line Reinforcement is the exclusive and first product in China. Through the search of foreign competing products, we also found that SIS Staple Line Reinforcement prepared by SIS materials for Disposable Circular Stapler reinforcement, it is unprecedented in the world. For SIS Staple Line Reinforcement for Disposable Linear Stapler, there are similar applications in the United States, but never entered China.

Moreover, we also found that SIS Staple Line Reinforcement used for Disposable Linear Stapler have many years of application experience in foreign surgery. As it is reported in the literature, there is a high incidence of anastomotic-related complications such as bleeding and anastomotic leakage during surgery with an stapler. A large-sample meta-analysis of 16,967 articles (56,309 cases included in anastomotic leakage related studies, 41,864 cases included in bleeding-related studies) indicated, the incidence of bleeding was up to 3.45% in cases without SIS Staple Line Reinforcement, the incidence of anastomotic leakage was up to 2.75%, however, the incidence of bleeding and anastomotic leakage with SIS Staple Line Reinforcement of animal-derived biomaterials decreased to 1.23% and 1.28%, respectively. The results significantly were better than applied suture reinforcement (the incidence of bleeding was 2.69%, the incidence of anastomotic leakage was 2.45%) and reinforced products with synthetic materials (the incidence of bleeding was 2.48%, the incidence of anastomotic leakage was 2.61%). This large meta-analysis showed that SIS Staple Line Reinforcement for sleeve gastrectomy and gastrojejunostomy surgery can significantly reduce the incidence of bleeding and anastomotic leakage, and that the biomaterial anastomotic reinforcement products are better than the synthetic material anastomotic reinforcement products.

In a prospective study of Biologic Staple Line Reinforcement products in 722 sleeve gastrectomy by Morris et al showed that the incidence of bleeding was 1.2%, and the incidence of anastomotic leakage was 0.6%, no postoperative deaths. The results indicating that non-crosslinked pig small intestinal submucosal material (SIS) could significantly reduce the incidence of anastomotic bleeding and anastomotic leakage during sleeve gastrectomy, confirming the safety and effectiveness of SIS materials for sleeve gastrectomy.

In 2020, the European Association of Endoscopic Surgery (EAES) issued clinical practice guidelines for weight loss surgery, summarizing the latest evidence on weight loss surgery and strongly recommending the use of SIS Staple Line Reinforcement during sleeve gastrectomy to reduce perioperative complications, including overall mortality and the incidence of bleeding.

Figure: some foreign evidence-based medical data

Product Superiority:

● National Medical Products Administration Special Approval Channel Products for Innovative Medical Devices (No.1,2018);

● Domestic exclusive full series of SIS Staple Line Reinforcement;

● World's first SIS Staple Line Reinforcement for pipe stapler;

● Accelerates anastomotic tissue regeneration and promotes anastomotic healing;

● Reduce anastomotic bleeding and reduce anastomotic leakage-related complications;

● Circular SIS Staple Line Reinforcement (can be used with Disposable Endoscopic Linear Cutter Stapler, Disposable Linear Cutter Stapler), flat type SIS Staple Line Reinforcement, round SIS Staple Line Reinforcement (used with Disposable Circular Stapler), unique invention patent can support most of the mainstream stapler manufacturers products.

This product has been on the market, and the national investment promotion has been officially launched. For more product details, please contact us.