Recently, at the main meeting of the TCT Conference (2018 American Conference on Transcatheter Cardiovascular Therapy), Ditch University Medical Center Mitchell W. Professor Krucoff presented a research report at the TCT Conference entitled "Biolimus A9 TM Drug-Coated Stent (DCS) for Critical Clinical Research in Patients with High Bleeding Risk." In addition, the blue fan medical products subsidiary of Biosensors occasion of clinical trials (LEADERS FREE II test) results are also presented in this meeting were released.
It is understood that the test is a key clinical research test for the registration of DCS (BioFreedom TM polymer-free drug-coated stent) of Parker International's flagship product in the United States, based on the FDA Research Instrument Exemption (IDE) program. United States, Canada, Denmark, France, Germany, Italy and the UK are involved in research centers, clinical results BioFreedom TM Biolimus A9 TM drug-eluting stent for patients with high risk of bleeding were observed in the study.
The results of the trial showed that the DCS scaffold (Biolimus A9 TM drug-eluting scaffold) has better safety and better quality than the BMS scaffold (metal bare scaffold) in the high-risk bleeding patients who underwent only one month of DAPT treatment. Efficacy.
The test results are expected to provide the first strong clinical evidence for the safety and efficacy of DCS implantation plus one-month ultra-short DAPT treatment strategy for patients with high bleeding risk in North America. The FDA is also completed for the BioFreedom TM stent in the United States. Pre-market approval (PMA) lays the foundation for a critical foundation.
Lanfan Medical was established in 2002 and successfully listed on the Shenzhen Stock Exchange on April 2, 2010. Its core product is health protection PVC gloves. Since 2013, Lanfan Medical has begun to explore the transformation and development, and takes the “protection + medical†dual field as the future development direction of Lanfan Medical. In order to achieve the goal of Lanfan Medical in the field of medical and health care, Lanfan Medical will enter the medical device field through mergers and acquisitions to achieve its leap from low-value consumables to high-value consumables.
Pershing International's products are based on cardiac interventional devices, including bare metal stents, drug-eluting stents, drug-eluting stents, balloon catheters and other interventional cardiac surgery products. In terms of scale, the global medical device industry and cardiovascular medical device sub-sector have maintained a continuous growth trend in the last decade. Parkson International is the world's fourth largest research and development, production and sales of cardiac stents, ranking second only to Abbott, Boston Scientific and Medtronic. It has a market share of more than 10% in EMEA (Europe, Middle East, Africa); its subordinates are wholly-owned The company Jiwei Medical has a market share of more than 20% in China and is one of the three giants in the field of cardiac stents in China.
Parkson International was included in the Bluefan Medical Organization System through acquisition. In the 2018 semi-annual report of Lanfan Medical, Lanfan Medical's acquisition of Parkson International was progressing smoothly and completed this on May 14 this year. For the delivery of the underlying assets of the major asset reorganization, the transfer of the underlying assets has also been completed.
Lanfan Medical has been engaged in the research, development, production and sales of medical gloves and health protective gloves. After the acquisition of Baisheng International, Lanfan Medical has added a new line of cardiac interventional devices based on its original business and realized low-value medical supplies. Strategic goals for the extension of high-value medical consumables business and industrial upgrading. It is also through the major asset restructuring, Lanfan Medical has added a new medical device for cardiac interventional device products. In recent years, the overall development strategy of “health protection + medical health†two-wheel drive medical device has been implemented.
However, after Baisheng International became an indirect holding subsidiary of Lanfan Medical, while the volume of Lanfan Medical Assets increased, the scale of business also expanded significantly, and the difficulty of communication and coordination increased, which gave management of Bluefan Medical and Operation brings certain pressures and challenges. Not only that, although Lanfan Medical and Parkson International belong to the medical device industry, and both have a sound organizational structure, an effective management system and a mature business model, the two belong to different segments and outside the Parkson International Department. Multinational corporations have certain differences with Lanfan Medical in terms of business model and internal operation management system, and there is still some integration risk.
In the announcement issued by Lanfan Medical, the release of this clinical data has no impact on the performance of Lanfan Medical in 2018, but may have a positive impact on the performance of the future. However, the BioFreedom TM stent from Pershing International is still subject to FDA PMA approval before it can be marketed in the US market.
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