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  • Grand Pharma Realizes its New Breakthrough in Coronary “Intervention without Implantation” Technology: A Coronary Drug-Coated Balloon – RESTORE DEB Receives Market Approval in China

    2019-10-28

    Recently, a drug-coated balloon for coronary intervention named "RESTORE paclitaxel-releasing coronary balloon dilatation catheter" (trade name: RESTORE DEB) has officially obtained the medical device registration certificate issued by the National Medical Product Administration. RESTORE DEB is produced by Cardionovum GmbH, a German based company which is acquired by Grand Pharma (China) Co., Ltd. (hereinafter referred to as Grand Pharma), indicated that the company has reached its 1st milestones to bring its product to the market. 


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    Acquired by Grand Pharma in 2015, Cardionovum GmbH is one of the successful acquisition cases of Grand Pharma  in medical device industry. Cardionovum GmbH stared with its own R&D and has been dedicated to the development of interventional products for  coronary and peripheral arteries. Its products, such as Drug Eluting Stent, Drug Coated Balloon etc. have been sold in more than 50 countries all over the world.

    According to data released by the 22nd National Interventional Cardiology Forum, in recent years, percutaneous coronary intervention (PCI) for coronary heart disease has made significant progress in China. Statistics from the National Center for Cardiovascular Disease Quality Control show that the number of PCI in China has increased from 500,000 in 2014 to more than 915,000 in 2018, surpassing the United States and ranking first in the world.

    It is known that use drug eluting stent to treat coronary stenosis remains the leading treatment in the world. However, there are still in-stent restenosis (ISR) which is caused by restenosis after implantation of stents and small vessel disease (SVD) which is a pain point in cardiovascular interventions due to limited vessel diameter. In the paper "Chinese Expert Consensus on Clinical Application of Drug-Coated Balloons" published in the Chinese Journal of Interventional Cardiology in February 2016, concluded through  clinical data provided by all parties, Chinese clinical experts said that use drug-coated balloons to treat intravascular restenosis can reduce the incidence to less than 10%.

    The marketing approval of RESTORE DEB has long been expected by cardiovascular experts. The concept of its design is: The anti-intimal hyperplasia drug (paclitaxel) is applied to the surface of the balloon; when the balloon reaches the target lesion in the vessel, the balloon is inflated to open the lumen of the vessel, meanwhile the drug coating contacts the surface of the lumen of blood vessel, and then the drug is rapidly released to the target lesion, thereby playing a role in anti-intimal hyperplasia, and also preventing restenosis after vascular intervention. In this case, the product delivers the drug to stenosis position, produces a revascularization effect, delays the neointima hyperplasia of the blood vessel, leaves no permanent implants, and preserve the vessel for further treatment. Regarding the duration of dual-antiplatelet treatment required, DCB treated patient requires shorter dual-antiplatelet treatment than those who receives stent implantation. It is an effective solution especially for patients who have surgeries short before the PCI, who cannot tolerate dual-antiplatelet treatment, and those who suffer from gastrointestinal bleeding. The launch of RESTORE DEB is expected to provide world-leading clinical solutions as well as first class safety for millions of patients who need cardiovascular interventions.

     

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    In addition, the clinical studies and registration processes of APERTO and LEGFLOW are also in process. They are also two innovative DCB products which independently developed by Cardionovum, Grand Pharma. The marketing launch of these two products will further expand the company's product pipeline in vascular intervention.

    In recent years, through rapid development, Grand Pharma has entered the rapid growth period of professional division of labor, international development, scientific research and innovation. Cardionovum is the first step of Grand Pharma in the field of international medical devices, will not only create economic value for the enterprise, but also train more talents and improve their experience through the strategic accumulation of “professionalization and internationalization”. In the future, by introducing products with synergistic effects, Grand Pharma will gradually expand its medical device portfolio which combines the function of “diagnosis” and “treatment”, create a platform for the introduction, research and development, production and sales of high-end medical devices, and accelerate the pace of research and development of its international, innovational and transformational products.