Cardiology Experts Converging with LINKS CRO to Boost Medical Device Innovation

2023-06-01

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       After a three-year hiatus, the 17th Oriental Congress of Cardiology (OCC 2023) returned on May 26th, 2023. This conference was hosted by Shanghai Medical Association and the Cardiovascular Disease Branch of the Shanghai Medical Association at the Shanghai World Expo Center. The domestic and international cardiology experts and opinion leaders in the field of cardiovascular disease brought together each other in this conference. Focusing on innovation and reaching an expert consensus. This event served as a crucial cooperation platform to promote the cardiology development and contribute to the progress of Healthy China Initiative.

       The conferees included a group of prestigious leaders and dignitaries, including Mr. Zhang Xiong, Deputy Secretary General of Shanghai Municipal People’s Government, Dr. Wu Jinglei, President of Shanghai Medical Association, Academician Han Yaling, Director of the Cardiovascular Disease Branch of the Chinese Medical Association, Academician Chen Yihan, Vice President of Tongji University, Academician Ge Junbo, Chair of the OCC and the Cardiovascular Physicians Branch of Chinese Medical Doctor Association, and President of CCI Innovation Academy, Professor Huo Yong from Peking University First Hospital, and Professor Ma Changsheng, Director-designate Member of the Society of Cardiology of Chinese Medical Association. Each of these esteemed individuals delivered an inspirational keynote speech, sharing their valuable insights and expertise in the congress.

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 Prestigious experts appeared at the exhibition booth of LINKS for guidance and communication 

(Academician Ge Junbo on the right, Dr. Chen Zhenlang at the middle, Director Pang Bo on the left)

       During the conference, Academician Ge called attention to the original research in China and expected more domestic original research in the latest clinical research sessions of international events such as ACC and AHA. During the break in the busy schedule of the event, Academician Ge appeared at the booth of LINKS to provide guidance. The marketing and export of innovative medical devices of China cannot be achieved without the assistance of excellent CROs. As a connecting hub, LINKS CRO has connected sponsors and clinical research organizations to boost clinical development and delivery. Academician Ge affirmed ’efforts of LINKS in clinical research and praised its professional competence in the cooperation, encouraging us to “keep a foothold in China and align to the global outsourcing of innovative devices and services.” Dr. Chen Zhenlang, the founder of LINKS, expressed that LINKS team will continue working hard to live up to the expectations of experts.

(The picture shows Professor Zhou Yujie)

        Professor Zhou Yujie, Executive Vice President of Beijing Anzhen Hospital, received a special interview during the cardiology time of OCC. In recent years, the drug-coated balloon (DCB) therapy based on the concept of “implantation-free intervention” has won more and more support among doctors and patients. Professor Zhou introduced how the therapy worked, and the application status of such devices in China. LINKS has served many similar products in the field of coronary artery and thus accumulated rich clinical test experience.1687143498363039.jpg(The picture shows Professor Ma Changsheng)

      Professor Ma Changsheng, Director of the Cardiology Center of Beijing Anzhen Hospital, delivered a keynote report on “AI Based Cardiology Management”, which started from concrete cases of the machine learning model and fully recognized the application capacity of artificial intelligence in the medical field. Professor Ma said, the application of AI-based cardiology management system could enhance the diagnosis and treatment efficiency so that patients in different regions could access fair, homogeneous, and affordable medical services.


(Director Zhang Gejun on the left, Dr. Chen Zhenlang on the right)

       Dr. Zhang Gejun, Deputy Director of the Structural Heart Disease Center and Director of the First Inpatient Area of Structural Heart Diseases in Fuwai Hospital, CAMS & PUMC, introduced the strategy selection for a variety of innovative devices, including the pulmonary valve leaflet, the only device to obtain the double certifications of CE and NMPA in the world.

1687143493624263.jpg1687145274267191.png(Professor Lu Fanglin on the right, Dr. Chen Zhenlang at the middle, and Director Pang Bo on the left)

       Professor Lu Fanglin, director of the cardiac surgery department with the First People’s Hospital Affiliated to Shanghai Jiaotong University, delivered a fascinating lecture on the progress of transcatheter tricuspid valve replacement. As one of the inventors of the domestically first-ever self-developed tricuspid replacement product, he has made a voice for the innovation of China in the international arena. During the conference break, Professor Lu visited the booth of LINKS to communicate and review the past cooperation with LINKS. As the CRO participating in the first and second generations of products in the important project, LINKS hoped that the product could hit the market sooner to benefit patients worldwide. For this purpose, LINKS has worked with the sponsors to embrace a bright future.

1687143495447745.jpg(Professor Kent So on the far left, Professors Zhang Xiaochun and Lin Yixian at the middle, Dr. Chen Zhenlang on the far right)

       OCC has always valued the academic exchange with the compatriots of Hong Kong, Macau and Taiwan. Professors Lin Yixian and Kent So from the Hong Kong Asia Heart Center are regular guests to the conference. The two said professors and another professor Zhang Xiaochun from Shanghai Zhongshan Hospital appeared at the booth of LINKS and had a warm communication with LINKS to retrospect the Asia-Pacific FIM and European Union CE-Mark researches and China’s confirmatory clinical validation conducted ten years ago on China’s first-ever innovative device, LAAC. It has initiated the animal training for structural heart diseases in China and overcome the (surgery) learning curve challenge faced by each clinical center through clinical teaching. LINKS has launched cooperation projects in Hong Kong, Japan and Europe, hoping to have more cooperation with the compatriots of Hong Kong, Macau, Taiwan, and overseas to support more overseas medical devices to enter China and promote more excellent domestic medical devices to take the international stage.


 Nonstop inquiries from customers 

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      OCC has set up a permanent international forum and invited a lot of cardiology experts and industrial elites from home and abroad to the event, with an aim to strengthen the academic exchange and boost the academic integration. During the exhibition, the booth of LINKS attracted lots of industry leaders from home and abroad for exchanging and inquiry. The business team have warmly and earnestly received every visitor. Medical Director Pang Bo led his medical team to help everyone plan the marketing strategy of products and the registration path for different medical devices according to related national laws and regulations. Moreover, some medical institutions, no longer content to wait passively, have tried to seek cooperation with LINKS. During the exhibition, LINKS received high acclaim from the clients.

      The chairman and CEO of a leading medical intervention enterprise of Japan visited the booth of LINKS for consultation. The founder Dr. Chen received the visitors and answered their questions, offering professional advice on the registration strategy for the company's products to enter clinical trials in China. The prudent attitude and professional explanation of LINKS were appreciated. Both sides expected mutual visits in the near future.


 The event concluded successfully,see you next time 

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      As one of the leading CROs and a top partner in the field of structural heart diseases, LINKS has been actively engaged in industry exchange activities and regulatory navigation. Starting from March, LINKS listened attentively to the interpretation of approval policies of the National Administration at the China International Medical Device Regulatory Forum (CIMDR) in Fuzhou and shared its practical experience at the forum, and studied the scientific clinical treatment path with the industrial experts at ChinaValve in Hangzhou in April. In May, LINKS exchanged the registration experience of innovative products with device manufacturers at CMEF in Shanghai. In addition, in late June, LINKS will make the voice of Chinese CRO heard with “(China) device innovation and development & challenges” at the European CSI in Germany. LINKS has always kept the industrial communication channels smooth according to related domestic and international regulations and systems, actively connected the sponsors and clinical research organizations to boost the efficient review of NMPA and accelerate the domestic and international commercial access.

      In the report delivered by President Xi Jinping on the 20th National Congress of the CPC, he emphasized to “promote the Healthy China Initiative”. In order to implement the Healthy China Initiative, LINKS has stayed true to its original aspiration, with an aim to connect sponsors, research institutions and researchers, help the enterprises shorten the cycle of their projects, cut their registration and R&D costs, and advance the marketization of the medical devices produced by domestic and foreign manufacturers.

The OCC concluded successfully

See you next tim


 LINKS CRO 

      As a CRO company providing clinical trial services. LINKS CRO focus on innovation, high-risk implantation(intervention) medical device, with one-stop clinical trial solutions for the whole process of medical device research and development.The headquarters of LINKS is based in Shanghai, with subsidiary branches in Beijing, Shanghai, Guangzhou, and Shenzhen, in addition to ten regional offices. The current workforce comprises almost 200 employees, with technical personnel making up over 85% and dispersed across almost 30 cities nationwide.   

      Key Services include CRO, SMO, CER, Audit, Post-market research, core laboratory registration both domestically and overseas, innovation declaration, Expert Consultancy, and overseas enterprise agency services.

      Key Indications include Cardiovascular, Neurovascular, Peripheral Vascular, Surgery Robot, Oncology, Ophthalmology, Medical Cosmetology, and other fields such as orthopedics. There are almost 300 projects consultations and services by LINKS each year.

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