Beijing, China - The 4th Edition of Vascular Innovation Symposium (VINNOVA), which was co-organized by China Association for Medical Devices Industry Vascular Devices Branch, the Professional Committee of Vascular Surgery of Chinese Research Hospital Association, Beijing Borui Vascular Health Charity Foundation and Beijing Zhongguancun Medical Device Technology Park and held by Chinese PLA General Hospital, took place in Beijing, China recently. The VINNOVA aims to be a platform serving the close communication among healthcare professionals, scientific research institutions, policy makers, the industry and investors with a focus on discussions about cutting-edge diagnostic and treatment technologies as well as evidence-based medicine researches for vascular diseases. The VINNOVA is also a platform for the exchanges on innovation and cooperation. Shanghai MicroPort Endovascular MedTech Co., Ltd. (Endovastec™) was invited to attend the symposium and present a series of products in the fields of aortic and peripheral vascular interventions. Several healthcare professionals spoke of innovative Endovastec™ products’ history of cooperation between the medical and engineering communities. With additional perspectives, the products’ clinical data and the commercialization of key technologies were also discussed as references for the multi-party cooperation involving medical device makers, universities and institutions.
Prof. Qingsheng Lu from Changhai Hospital of Shanghai delivered a speech titled “Branching Techniques: Past and Present of Castor®” to reflect on his experiences during the cooperation with Endovastec™. The birth of Castor®, which is the world’s first branched aortic stent, resulted from the close cooperation between the doctors from the vascular surgery department of Changhai Hospital and the R&D engineers from Endovastec™. The very cooperation was embodied in every and each step during the R&D, from preliminary ideas of the clinicians to their collisions with scientific researches, from perceptions on the ways of commercialization to multi-party material and engineering researches, and from animal trials to pre-marketing clinical studies. The commercialization of clinicians’ ideas is time-consuming and challenging, during which mutual understandings and thinking in other persons’ shoes are required of the clinicians and clinical engineers to ultimately achieve double wins and complete product commercialization through technological discussions and trade-offs once and again.
Prof. Kun Fang from Chinese Academy of Medical Sciences Fuwai Hospital spoke of the Thoughts on Design and Clinical Application of the distal microporous stent graft. He pointed out that the handling of the distal tear of aortic dissection is prone to be neglected but proved to be serious, in that the new distal tear and paralyses are serious complications after performing thoracic endovascular aortic repair (TEVAR) procedures. Currently, the distal tear is principally handled with multi-layer stents, false lumen plug technique and Petti coat technique. Endovastec™ has developed a stent capable of “breathing” - Talos™ Thoracic Stent Graft System (“Talos™”), which can both better reshape the distal true dissection and reduce paralysis rates. Talos™ measures 60-260 mm in lengths with a distal pore design to ensure the perfusion of distal intercostal arterial. The tapering design of the stent body is applicable to aortic dissection patients. Currently, the pre-marketing clinical study for Talos™ has enrolled 132 subjects with good immediate and short-term follow-up results, while its long-term efficacy requires the support of more cases and follow-up statistics.
Endovastec™ R&D Senior Director Dr. Zhengyu Yuan spoke of the principle and clinical practice of Low Profile delivery sheaths. He pointed out that according to scientific papers, the patients who are denied access to endovascular aortic repair (EVAR) due to vascular access stenosis and tortuous calcified anatomies account for 6% to 19% of the total number of patients. The application of Low Profile delivery sheaths can widen the indications for EVAR and reduce complications caused by incision approach. Currently, the outer sheaths of the abdominal aortic stent in the market are of the specifications between 14F-24F. The R&D staff of Endovastec™ started from the graft materials, stent structure and process to decrease the profile by applying low permeability, low thickness, wear-resistant graft, downgraded the wire diameter of metal stent, laser cutting and tooling installation. The outer sheath of the delivery system of Minos™ Ultra Low-Profile Stent Graft (“Minos™”) of Endovastec™, which was launched in March 2019, adopts a super Low Profile design to decrease the outside diameter of the delivery sheath to 14F. With the requirements on vascular access in EVAR significantly lowered and the indications for EVAR increased, Minos™ demonstrates evident advantages in the cases featuring vascular access stenosis and tortuous calcified anatomies. During its pre-marketing clinical study, the enrolled patients, with 75.3% of them having below 7mm access aorta diameters, demonstrated primary technical success rates of 97.1% at 30 days and 89% at 12 months, type I/III endoleak and second intervention rates of 2.2%, with the long-term large-scale clinical data due upon further follow-ups.
As currently the only Chinese-made abdominal aortic stent graft product with independent intellectual property and the capability to lower the outside diameter of the delivery sheath to 14F, the launch of Minos™ provided a better solution for the patients suffering abdominal aortic aneurysms with complex anatomies and particularly benefitted more patients with vascular access stenosis and tortuous anatomies. Endovastec™ will adhere to a R&D rationale of continuous innovation to provide the patients suffering aortic and peripheral vascular diseases with more personalized therapeutic solutions and services.