MitralStitch ™, China First Transcatheter Mitral Valve Repair

There is no need to split the sternum, no extracorporeal circulation and a mitral valve repair in 25 minutes. January 19, 2018, the world’s first clinical completion of Fu Wai Hospital in Yunnan Province of MitralStitch ™ mitral valve repair system. Under the guidance of the academician Hu Shengshou of Fuwai Hospital, this case was completed by Professor Pan Xiangbin team together with Professor Meng Xu of Beijing Anzhen Hospital. The MitralStitch ™ mitral valve repair system independently developed by Dehnen’s Hangzhou Dejin Medical Technology Co., Ltd. was used which marks the first clinical application of minimally invasive mitral valve therapies in the world that can be performed simultaneously with chordal implantation and edge-to-edge repair.

Mitral regurgitation (MR) is the most common heart valve disease due to organic or functional changes in the mitral valve leaflets, valve annulus, papillary muscles, tendons, etc., leading to anterior and posterior mitral anastomosis. According to the United States relevant statistics, the number of patients with mitral regurgitation is about 10 times the number of patients with aortic stenosis in the United States 4.6 million patients with mitral regurgitation, it is estimated that the number of patients with severe mitral regurgitation in China 10 million or more, but the rate of surgical treatment less than 2%.

Whether traditional endoscopic small incision under the guidance of surgery, heart valve surgery require extracorporeal circulation support, catheter-mediated mitral valve therapy will be unable to get surgical treatment of patients, especially in moderate to severe Mitral regurgitation and surgical contraindications in patients with high risk. Mitral valve structure and mitral regurgitation causes are very complex, the difficulty of catheter repair mitral valve is very large. Professor Meng Xu, chief medical expert of the team, said: “mitral valve intervention is similar to piloting a plane and requires consideration of its complex anatomy and limited imaging navigation And use catheters for long-range surgical procedures. “A number of clinical data indicate that transcatheter mitral valve repair has a very positive response to moderate to severe and severe patients. R & D funds for the surgical products are technology-intensive. Currently, there are a number of mitral valve related devices in development around the world, but there are a very limited number of products that are already on the market and certified by the European CE and the US Food and Drug Administration (FDA). The certified products are own by large multinational medical device companies.
The academician Hu Shengshou has a long-term vision and committed to the formation of composite technology team. He joint a manufacturing enterprises to develop China’s own transcatheter valve repair equipment. Adhering to the concept of innovative research and development technology, Deno Medical Group started in 2014 devoted a lot of resources committed to the research and development of domestic minimally invasive mitral valve products, Hangzhou Dejin Medical Technology Co., Ltd. was established in 2015, Hangzhou Dejin The Fuwai Hospital and Beijing Ahn Jung Hospital formed a research team of production, education and research, brought together clinical experts and engineers and successfully developed the first MitralStitch ™ mitral valve repair system in China for minimally invasive mitral regurgitation.

MitralStitch ™ uses minimally invasive transapical approaches to repair mitral regurgitation. The highlight of MitralStitch ™ is that it can both perform simple artificial tendon grafting and perform Edge to Edge mitral repair. The anterior leaflet and the degree of traction after the pull can be adjusted. Compared with the popular Mitralclip system on the international market. MitralStitch ™ can be used to repair and treat organic mitral regurgitation (DMR) and to repair functional mitral FMR is the world’s first technology. In contrast to the Mitraclip system, which has to pass through the femoral artery approach, the MitralStitch ™ mitral valve repair system translates to a shorter operating and greater instrument control and avoids the need to reach the surgical site which may happen with Mitraclip in case of potential risk during the intervention. This China-made “smart” product has complete independent intellectual property rights both at home and abroad and is a real China technology and China program.

During the operation, the elderly patient who received the treatment had a small incision of about 3 ~ 4cm in the patient’s rib. After the apex was completed, the pachytene was introduced into the MitralStitch ™ mitral valve prosthesis system. Under the guidance of esophageal ultrasound, the instrument was used to clamp the posterior mitral valve prolapse and Implant artificial chordae. The procedure was timed from the introduction of MitralStitch ™ to the implantation of the artificial chordae performed in 25 minutes. Immediately after surgery, the degree of mitral regurgitation decreased, and the reflux area decreased from 11.3 cm 3 to 1.3 cm 2. On the third postoperative day, the patient’s recheck ultrasound showed a slight decrease of reflux degree , Mitral valve function is normal, symptoms improved significantly.