China med Device, LLC provides market access research for Western medical device companies. Recently MinSheng Pharma published an in-depth analysis on China CVD market. CVD is not only the top killer in the world but also the #1 killer in China. In Beijing, for example, the total loss of life expectancy due to CVD is estimated at 317,813 person-years. That is, the loss of life per thousand people is 24 person-years.
Drug is still the number 1 method of treatment. Patients are generally accustomed to the relevant chronic disease management process. Since pharmaceutical manufacturing is a highly profitable business, innovative drugs continue to come to market. For example, long-term low doses of aspirin can prevent heart disease, stroke and thrombosis and can delay the onset of cardiovascular disease.
However, for critically ill patients, drug have limitations. Under such as congenital defects, atherosclerosis caused by coronary artery disease, severe heart valve diseases, patients need to be treated more than that. Interventional treatments include PCI, bypass, open heart cardiac surgery, heart transplantation etc.
Vascular stent has a long history and an increasing application in China market. The localization rate continuously goes up thanks to frequent R&D breakthroughs. With more and more cases, surgery operations and equipment market continue to expand.
In recent years, CFDA has issued a series of regulatory documents and strengthens its reviews of application from players in the field of stent. Since domestic stent gains more market share and the tender price limit decreases, the price of cardiac stent has dropped more than half from the level at the beginning of this century. With fierce competition, market research and development begins to turn to a new direction focused on the long-term medication needs and the issue of stent thrombosis.
Although Abbott’s dissolving stent has hit the market, drug-eluting stent (DES), as well as its variants, is still the market dominator. In China, domestic DES has been used in more than 80% cases. According to current clinical study, rapamycin is the mainstream of DES. Except for allergy to rapamycin, the use of paclitaxel has been declining. Everolimus, as a rapamycin derivative, won positive clinical reactions and serves mainly for imported products. Existing DES have relived patients from long-term drug needs on a large scale.
One solution to DES is to allow the solid part to dissolve gradually after the completion of its mission. Abbot selects material absorbable to human body, tries to make the stent body degrade in 2-3 years and ultimately leave nothing in the vessel but the platinum bracket on the edge of stent. Dissolving stents are basically developed based on mature drug-eluting stents. The major innovation is the adoption of new materials. Abbott’s Absorb GT1 system was approved by FDA on July 5, 2016. Its short-term clinical results are similar to those of Abbott’s previous mainstream DES, Xience. Absorb uses the same surface structure as Xience (ie, the Abbott-registered Multi-Link pattern), as well as the elution drug: everolimus, a derivative of rapamycin sirolimus.
However, full-dissolving PLA still faces difficulties such as mechanical strength, metabolic products that cause vascular stenosis and other issues. The operation is not easy. Also, postoperative stent thrombosis problem is not lower when compared with the traditional DES. With higher prices, marketing promotion relies on further research and development improvement.
On the other hand, Boston Scientific chooses a different plan from Abbott to develop its own SYNERGY stent. Synergy was approved in Europe in 2012, earlier than Absorb in the United States in October 2015. Like Absorb, the development of Synergy has also followed the process of the Boston Scientific’s older DES generation, PRDSUS Element, in terms of structures and the slow release of drugs. However, Synergy eventually leaves a thinner metal stent, which can be called an incompletely dissolving stent. Synergy’s metal stent will eventually be wrapped in endothelialized vascular wall cells to reduce stent stimulation of the affected area, thereby avoiding the formation of thrombus in the stent. In contrast to Absorb, Synergy is more traditional, focusing on innovation about the surface treatment process and drug release time, rather than an absolute change of stent structure.
In China, there are also two major R & D paths for stent. Companies such as LEPU Medical follow Abbott, try to develop PLA biodegradable materials and fully dissolving stent with the aiding of their own mature DES processes and structures. On the other hand, Amsino Medical represents companies that are devoted to promoting the existing DES, improving the surface treatment, drug release and other processes, and thus enhancing the effect of endothelialization.
Lepu’s dissolving stent has entered special approval process. Analysts believe that the first half of 2018 will see China’s first approved dissolving stent; the company itself is in preparation for clinical trials in Europe and has confidence in the reaction from domestic market. XINSORB supported by Prof. Ge Junbo with Fudan University also entered the approval process specifically for innovative medical devices. XINSORB has a similar basic principle to Absorb, with the use of PLA as stent material and location logos on both sides of the stent.
Microport adopts another path with its Firehawk coronary thalamycin Target Eluting Stent (TES). Known as “the world’s first and only TES system”, Firehawk is structurally like EXCEL and SYNERGY. With a directional groove at the vascular wall side of the metal stent, Firehawk integrates 3D printing technology to control drug release, reduce drug loading and polymer loading, and accelerate endothelialization.
Absorb and SYNERGY represent two major innovation trends: full dissolving stent and enhanced surface treatment with metal structure support. Each trend has its own pros and cons, thus unfolding continuous R&D. Based on existing technology development and clinical effects, PLA cannot completely solve the problem. It will rely on clinical and market reactions to see which trend will outperform the other.
Apart from stent, artificial heart is another promising field of CVD research. Nowadays, SynCardia has developed portable devices that allow the patient to act on his or her own, recharge at home and even take mild exercises, offering a better survival experience and physical reserves. In addition to total artificial heart (TAH), the assisted artificial heart is more widely used. Three different kinds of devices, including left ventricular assist device (LVAD), right ventricular assist device (RVAD), Bi-ventricular assist device (BiVAD) three, are applied to different cases and conditions.
In future, China will enhance the administration reviews and narrow industry access standards. At the same time, China will also strengthen the support of domestic manufacturing with respective policies. For example, the National Development and Reform Commission has enlisted in the guide directory about strategic emerging industries key products and services such as balloon dilatation catheter, cardiovascular and cerebrovascular stent, artificial valve, etc. The State Council has published Made in China 2025 as well, in which lists high-value medical disposables like dissolving stent.
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