Since SIS Staple Line Reinforcement obtained certification in early August, the clinical application of major hospitals across the country has also been launched in succession.
After officially entered the Hubei Province Cancer Hospital, recently, the good news spread again. On October 13th, Xiao Zhigang's team, director of the Colorectal Anal Surgery Department of Hunan Provincial People's Hospital, completed the clinical application of SIS Staple Line Reinforcement, and received a good response.
Surgical Method: Total Gastrectomy
Time of operation: October 13th
Product intraoperative application:
1. Duodenal dissection
2. Esophagus and jejunum anastomosis
Figure: demonstrate of anastomosis after duodenal dissection
Figure: The specialist team performed esophageal and jejunal anastomosis using staplers loaded with SIS Staple Line Reinforcement
Usage feedback from Director Xiao Zhigang's team :
1. The SIS Staple Line Reinforcement is simple and convenient to use, with good compliance, and it is smooth and pressure-free through the 12mm trocar.
2. After loading the SIS Staple Line Reinforcement, the back line needs to be removed through the pull wire before firing. The operation is simple, and the back line is easy to be pulled out.
3. In the condition of loading the SIS Staple Line Reinforcement, no resistance increases, no impact on the seam and nail molding and no bleeding occurs in the cutting edge and the seam and nail line.
4. The anastomosis lip is very "strong" and does not need to reinforce the suture twice.
5. SIS biomaterials are used for SIS Staple Line Reinforcement. According to reports, SIS material have effect of rapid vascularization, accelerate anastomotic tissue regeneration and promote anastomotic healing. We will continue to pay attention to the patient's recovery in the follow-up visit, and actually verify the product effect.
博瑞强TM SIS Staple Line Reinforcement
博瑞强TM 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
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.