WeKo Medical Announces Successful First Overseas Implantation of D-shant® Atrial Shunt for Heart Failure Treatment
Vickor
Structural Heart Disease Minimally Invasive Intervention Product Developer
July 18,Professor Teguh Santoso's team from Medistra Hospital, Jakarta, Indonesia, applies Vickor D-shant.®Atrial Shunt Device Treats a Patient with Left Heart Failure, with On-Site Professional Support Provided by Professor Zhang Changdong from Professor Dong Nianguo's Team at Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.This milestone surgery is not only a significant achievement for Vickor's D-shant®The international debut of the atrial shunt device marks a breakthrough step for domestically produced atrial shunt devices entering the global market, showcasing the international recognition of their innovative design and clinical value.
A 71-year-old male patient with a three-year history of heart failure, during which medication was taken intermittently. Recently, he experienced acute heart failure. Angiography revealed triple-vessel disease of the coronary arteries, and PCI (percutaneous coronary intervention) surgery has been completed. Echocardiography indicated: ischemic cardiomyopathy after myocardial infarction, severe left ventricular dysfunction, LVEF 31%; right ventricular dysfunction, TAPSE 1.6 cm, right ventricular fractional area change 34%; IVC 1.6 cm, with respiratory variation rate <50%; RA area 12 cm², RA dimensions 48*37 mm.Despite the implementation of optimal Guideline-Directed Medical Therapy (GDMT) and comprehensive device management strategies in accordance with international guidelines, the patient's clinical condition remains inadequately controlled.
In view of the complex conditions mentioned above and the limitations of traditional treatment methods,Professor Teguh Santoso's team after rigorous evaluation and in-depth discussion,Decided to adopt a more cutting-edge and innovative treatment method - D-shant®Atrial Shunt Implantation.Using D-shant®The unique design of the atrial shunt device achieves stable and controllable redistribution of blood flow between the atria, effectively reducing left atrial pressure, improving pulmonary circulation congestion, alleviating patient symptoms, and is expected to optimize cardiac function in the long term, reduce rehospitalization rates, and improve quality of life.
Right femoral vein puncture was performed for right heart catheterization to calculate pulmonary resistance and cardiac output. Then, under transesophageal echocardiography guidance, atrial septal puncture was conducted. Left atrial pressure was measured at 44/25 (31) mmHg, right atrial pressure at 16/7 (10) mmHg, and pulmonary artery pressure at 64/25 (38) mmHg. The left-to-right pressure gradient corresponded to the hemodynamic characteristics of left heart failure without pre-capillary pulmonary hypertension.
A 6mm aperture shunt device was delivered and deployed on both sides of the atrial septum. A push-pull test confirmed stable fixation and optimal positioning of the shunt device, with fluoroscopic imaging showing the aperture meeting the expected target. Measurements indicated left atrial pressure at 25/10 (15) mmHg, right atrial pressure at 8/5 (6) mmHg, and pulmonary artery pressure at 52/20 (31) mmHg, all decreased compared to pre-implantation levels. The left-to-right shunting was minimal. Bedside echocardiography showed the shunt device securely positioned on both sides of the atrial septum. Evaluation confirmed the desired outcome, and the shunt device was released. The patient's hemodynamics significantly improved, marking the procedure as successful.
Postoperative Ultrasound Evaluation
At the forefront of exploration in the field of heart failure treatment, Vickor has always played a pioneering role.D-shant®The atrial分流器 is an implantable atrial分流 device with complete independent intellectual property rights, known for its unique design and potential therapeutic advantages.Included in China's Innovative Medical Device Approval Green Channel and received the FDA "Breakthrough Device" designation in the United States.。
After a series of rigorous and scientific clinical trial validations, D-shant®The atrial分流器has demonstrated remarkable efficacy in optimizing hemodynamic parameters, effectively controlling disease progression, and significantly enhancing cardiac function in heart failure patients. Long-term follow-up data confirms that this device can improve patient prognosis, elevate quality of life, and pave a new therapeutic pathway in the field of heart failure treatment, effectively addressing the limitations of traditional therapies.
This D-shant®The first overseas application of the atrial shunt device is not only a key milestone in Vickor's global strategy journey but also an important symbol of Chinese medical technology products going global and showcasing China's innovative strength.Vickor will continue to focus on the treatment of heart failure and structural heart disease, committing to develop more innovative medical devices with independent intellectual property rights, providing safer and more effective medical solutions for patients worldwide.
