Shanghai, China – The National Continuing Education Classes of China Endovascular Course 2018 (CEC 2018) was recently held at the Shanghai International Convention Center in Shanghai, China. The event was jointly organized by Zhongshan Hospital Affiliated to Fudan University, Beijing Anzhen Hospital of Capital Medical University, Chinese PLA General Hospital, Cross-Strait Medicine Exchange Association, and China Research Hospital Association, with the attendance of nearly 4,000 Chinese and overseas cardiologists. Shanghai MicroPort Endovascular MedTech Co., Ltd. ("Endovastec™") presented at CEC 2018 the products of Castor® Branched Aortic Stent-Graft System ("Castor®"), Minos™ Ultra Low-Profile Stent Graft System ("Minos™"), and Reewarm™ PTX Drug Coated Balloon (Reewarm™).
The event covered extensively the scientific hot topics in the field of vascular diseases globally, containing 171 speeches, 93 surgery demonstrations, two live cases, and 60 edited cases. The organizations of SVS, the Japanese Society for Vascular Surgery, LINC, SITE, and Veith also hosted sessions at CEC 2018. EndovastecTM sponsored the session of Challenging Aortic Arch Disease, where several healthcare professionals spoke of the clinical application of Castor®, presented edited cases, and discussed in detail the device's development history, operational skills and clinical cases.
During the Edited Case session, Prof. Wei Guo from Chinese PLA General Hospital demonstrated an edited case of reconstruction of the aberrant right subclavicular artery with Castor®. The patient, 40, male, was hospitalized due to acute aortic dissection, with the primary entry tear of dissection located 2 cm far from the distal of the left subclavian artery. The aberrant right subclavicular artery originated from the lesser curvature side of the aortic arch, which was opposite the primary entry tear. The Castor® was used during the procedure to reconstruct the aberrant right subclavicular artery and achieved good post-operative effect with the tear fully blocked. Prof. Wei Guo commented, "Castor® adopts a standardized product design to cover multiple anatomies and reconstruct the branched aorta in a unibody manner, which requires careful assessment with the measurement program ahead of the procedures to optimize the procedure plan."
Prof. Qingsheng Lu from Changhai Hospital of Shanghai demonstrated an edited case of reconstruction of left subclavian artery with Castor®. The patient's aortic arch is bovine aortic arch, with the innominate and left common carotid arteries originating from a common trunk. The primary entry tear of dissection was located at the end of the left subclavian artery. After the reconstruction of the left subclavian artery with Castor®, the angiography showed that the primary entry tear of dissection had been fully blocked without endoleak. Prof. Qingsheng Lu commented, "The pre-operative measurement should be precise to facilitate a good assessment of the case. Then a stent graft of a proper size should be selected. During the procedure, the operation flow for Castor® should be strictly followed, with the branches and main body going through the truth lumen with precise positioning. The stent should be released fast, with the speed little changed."
During the speech session, Prof. Qingsheng Lu focused on an analysis on the design features and clinical data of Castor®. He said that the R&D and launch of Castor® was important for China's vascular surgery community as it is the world's first branched aortic stent graft system. It adopts a unibody design to reconstruct the left subclavian artery simultaneously with good long-term fatigue resistance. Compared to modular stent graft, Castor® avoids the assembly inside the body, so that it requires less space and is more suitable for aortic dissection patients. Before its launch, the cases enrolled in the clinical trials of Castor® were even more critical (acute, landing zone). However, the rates of mortality and complication incidents were basically on par with those of conventional TEVAR procedure, with a 97.26% success rate for the Castor® procedures, 0% incident rate of stent-related neurological complications, and 5.48% incident rate of neurological complications. The incident rates of neurological complications stood far below those of other branched stent graftsmade either in China or overseas.
Prof. Xiangchen Dai from Tianjin Medical University General Hospital spoke of the application of on-table fenestration and branched stent graft technique at aortic arch. He pointed out that the single-branched stent graft and the stent graft with a single fenestration share the same technical essentials, while the single-branched stent graft does not have type III endoleak. In addition, Castor® is already released to the market with lower risks with respect to techniques and laws. The inside multi-branched stent graft is still not available in the market of the Chinese mainland, and it can be used in the reconstruction of three branches of the arch. For the endovascular reconstruction of the left subclavian artery, Castor® is the best choice, and the on-table fenestration (dissection) or a combination of fenestration and branched stent graft (thoracic aortic aneurysm) can be used for multi-branched reconstruction.
Prof. Haofu Wang from the Affiliated Hospital of Qingdao University spoke of his experience in the application of Castor®. He said that the techniques used to maintain the left subclavian artery include hybrid, fenestration (on-table fenestration and in-situ fenestration), chimney, and branched stent graft. In accordance with the physical conditions and surgical conditions of the patients, various types of techniques are applied in clinical use with effect. China is leading the world in the field of endovascular therapy of aortic dissection. The Castor® produced by MicroPort® Endovascular is the world's first of its likes, with good clinical record in the past year since its launch.
Prof. Weiguo Fu from Zhongshan Hospital spoke of the pre-market multicenter clinical trial results of Minos™. He commented that Minos™ had demonstrated unique advantages in the treatment of complex abdominal aortic aneurysms, especially in the cases of vascular access stenosis, tortuous or short neck anatomies. Minos™ had showed a good performance in the pre-market multicenter clinical trial, with a 100% success rate at 30 days, a 97.1% success rate for the main technique, and no stent graft migration or occlusion.
Prof. Changwei Liu from Peking Union Medical College Hospital spoke of the pre-market clinical results of Reewarm™. He pointed out that Reewarm™ is mainly used in the treatment of lower extremity femoral artery stenosis or occlusive lesions. It adopts the process of ultrasonic spraying to ensure even and stable drug coating. The use of an exclusive coating ingredient helps the drug enter the blood with the protection of a water soluble carrier. When the carrier dissolves, the static electricity makes the drug particulars stick together and prevent their disintegration. Then the drug will be quickly released after the dilation of the balloon. The statistics showed that the rate of late lumen loss at six months was significantly lower with Reewarm™ than with bare balloon catheter. The rate with Reewarm™ was also little changed from that with the imported similar products. In the future, the safety and efficacy of Reewarm™ need to be verified with complete case data and long-term follow-up studies.
During CEC 2018, Endovastec™ also invited the healthcare professionals who were frequent users of Castor® to join in a talk with the developers on the product's post-marketing clinical data, clinical issues, and potential improvements. Furthermore, Endovastec™ demonstrated the characteristics and operational skills for various kinds of aortic products through simulators, customer discussion, and product brochure explanation at the booth. In the future, EndovastecTM Endovascular will continue to enhance the communications and exchanges with healthcare professionals, listen to the demands and suggestions of the clinicians, continuously improve and optimize product performance at such international events as CEC 2018. The company will commercialize the best yet affordable therapeutic solutions to save, transform or improve the patients' lives.