According to the statistics of the World Health Organization (WHO), about 17.7 million people worldwide died of cardiovascular disease in 2015, accounting for 31% of the global death toll, making it the deadliest disease in the world.

Coronary heart disease is a common illness of cardiovascular disease which is treated mainly through medicines, coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI). Remarkably, PCI is preferable to both clinicians and patients for its short treatment course, small wound and significant therapeutic effects: doctors can use PCI to open coronary arteries that are narrowed or blocked by the buildup of atherosclerotic plaque without thoracotomy.

Today, Ddu is going to share the market report of coronary stent with you.

I. Coronary stent market in China

The incidence of coronary heart disease in China has been close to that of the United States and other developed countries. At present, the number of domestic coronary heart disease patients reached 20 million with an increase of more than 1 million new patients each year. In 2016, there were more than 1.2 million PCI cases in China.

Cardiac stents are high value consumables used for the treatment of cardiac atherosclerosis. With an increasing incidence rate of coronary heart disease and the improvement of medical technology, more and more people receive PIC treatment. At the same time, an increasing number of people are now able to afford heart stents due to price reduction and improvement of life standards, contributing to the dramatic development of the market.

The number of PCI cases which require heart stents increased from 300 thousand stents in 2008 to 1.6 million stents in 2016, of which 93% were drug-eluting systems.

In 2016, per capita use of stents in PCI operations remained at 2.2/person and the domestic demand for cardiac drug stent systems will show a rapid growth in the future.

II. Global market of coronary heart stents

Products of coronary heart stents are popular among patients. In 2016, the global market of coronary heart stents reached 10.6 billion USD.

Although many medical companies are constantly developing new coronary stents, this market is dominated by several major medical giants such as Abbott Vascular, Medtronic, Boston Science, Parsons International and Tyler.

In terms of clinical use, doctors think highly of the products from Abbott Vascular and Medtronic, both for their characteristics and brands. Lepu Medical from China is also popular but still trails behind Abbott Vascular and Medtronic.

III. Steady export of coronary heart stents

With successive breakthroughs in the technology of drug-eluting stents, domestic companies like Lepu have rolled out products with IPR and have gradually entered into a stage of mass production and exports.

According to custom data, China’s drug-eluting export business has been expanding for the past couple of years with the number of its exporting countries increasing from 22 in 2013 to 65 in 2016. During January 2016 to July 2017, China’s  coronary heart stent export sales of the top ten countries it exports to, exceeded 12.78 million USD.

IV. China’s benchmarking companies

Most Chinese companies are doing well in regards to international market development. Here follows a list of some of the benchmarking companies in this industry (in no particular order):

1. Lepu Medical Technology (Beijing) Co., Ltd.

Established in 1999, Lepu Medical Technology (Beijing) Co., Ltd. specializes in high-tech medical device development, production and sales. Lepu has built up a leading group company concentrating on cardiac therapy, with products including interventional cardiology, occlusion devices, prosthetic heart valves, pacemakers, cardiac in vitro diagnosis products, angiographic equipment and anesthetic products. In Oct. 2009, Lepu successfully listed on ChiNext of the Shenzhen Stock Exchange market (stock code: 300003).

2. LifeTech Scientific Corporation

LifeTech Scientific Corporation (Stock Code: 1302.HK) is the leading supplier of minimally invasive interventional medical devices to treat cardiovascular and peripheral vascular diseases. The company specializes in R&D, manufacturing and sales and its high-quality, innovative, proprietary products are extensively marketed in the world by distributors, spread across Europe, South America, Asia, Africa and other regions. At present, the company is the world’s second largest supplier (and the largest among BRIC countries) of occluders to treat congenital heart diseases.

3. MicroPort Scientific Corporation

MicroPort Scientific Corporation can trace its origin back to 1998 to a small office at ZJ Hi-Tech Park, Shanghai, China, where a group of dedicated individuals joined together with a common belief that advancements in medical technology could transform and enhance patients' well-being, not just in China, but globally. During the past decades, the pioneers of MicroPort® have devoted themselves to this mission of advancing the forefront of technology innovation to develop the best and most affordable medical therapies to treat patients around the globe.

4. Sino Medical Sciences Technology Incorporation

Sino Medical Sciences Technology Inc. (SINOMED) is a global company engaged in research and development, production and sales of interventional medical devices. SINOMED was founded in 2007 by Dr. Jianhua Sun (CEO) with shareholders who are renown international institutional investors. Heart stents developed by SINOMED with complete IPR, redefined China in the world as an inventor instead of an imitator.

V. Development trend of stents

With more and more drug-eluting stents being applied for clinical use, its excellent clinical efficacy has brought great encouragement and hope to both doctors and patients. Although the first generation of drug-eluting stents (DES) effectively reduced the rate of intravascular restenosis, it still delays the repairing of endothelium when it manages to inhibit the proliferation of vascular smooth muscle cells, thereby increasing the risk of thrombosis caused by the stent. Recent clinical studies have shown that the mortality rate caused by late thrombosis of DES is to some extent higher than that of bare metal stents.

So what is the ideal drug-eluting stent and how would it be developed in order to meet  the demands of clinicians? Ddu will now discuss how the improvement of DES casts, impacts clinical efficacy from the perspective of design and R&D of manufacturer..

According to our observations, polymer accounts for stent thrombus in the late stages. Attempting to eliminate or reduce the negative effects of polymer has become a main point of focus for doctors and stent manufacturers. Please look at the following examples.

Nevo, J&J’s stents (USA) of the latest generation, are composed of slotted stents made of cobalt-chromium alloy and PLGA + Sirolimus coating.

Medtronic’s stents (USA) of the latest generation, are designed with no polymer layer. The Resolute Onyx DES is the first and only DES to feature Core Wire Technology, an evolution of Continuous Sinusoid Technology (CST). CST is a unique Medtronic method of stent manufacturing, which involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. This enables greater deliverability and conformability to the vessel wall. With Core Wire Technology, a radiopaque inner core is incorporated within the cobalt alloy wire, to enhance visibility for accurate stent placement. Core Wire Technology also enables thinner struts while maintaining structural strength. The Resolute Onyx DES is designed with the transradial approach (through the wrist) in mind, including 5 Fr catheter compatibility with stent sizes up to 5.0 mm. With the first 4.5 mm and 5.0 mm DES sizes available in the U.S., the Resolute Onyx DES helps expand treatment options for patients with extra-large vessels.

The fourth-generation SYNERGY™ Coronary Stent from Boston Scientific, uses a bioabsorbable PLGA polymer and everolimus drug formulation to create a thin, uniform coating confined to the outer surface of the stent. Once the drug has been delivered, the bioabsorbable coating is resorbed into the body, leaving behind only a bare-metal stent. This technology is designed to provide the same degree of restenosis reduction as a conventional drug-eluting stent, while offering faster and more complete vessel healing after stent implantation. The SYNERGY Stent features the same proprietary platinum chromium alloy and innovative stent design used in the PROMUS® Element™ Stent to enable thinner struts, increased flexibility and a lower profile while improving radial strength, recoil and visibility.

In addition to that, fully absorbable coronary drug-eluting stents are mainly divided into fully absorbable polymer scaffolds and fully absorbable alloy stents. Their representative products are Abbott's polymer biodegradable scaffold BVS and Biotronik. magnesium base alloy drug-eluting stent AMS respectively.

The Absorb GT1 Bioresorbable Vascular Scaffold (GT1 BVS) System is a fully absorbable stent mounted on a balloon dilatation catheter. It is made of an absorbable polymer, poly (L-lactide) (PLLA), with a thin coating of the absorbable polymer poly (D, L-lactide) (PDLLA) containing the drug everolimus. The absorbable stent contains two platinum marker beads, one embedded at each end. The delivery system is comparable to the one used in Abbott Vascular's XIENCE Alpine Coronary Stent System (CSS) (P110019/S066).

The absorbable stent is placed into a blood vessel (coronary artery) during angioplasty to help keep the coronary artery open. The stent dissolves and will be absorbed by the body in approximately three years, leaving behind only the platinum markers.

Biotronik's magnesium-based alloy drug-eluting stent AMS 3.0 "DREAMS" is made of 93% magnesium and 7% rare-earth metals. It induces rapid endothelialization, has low thrombogenicity, and a degradation time of 2-3 months. Magnesium was chosen because it is an essential mineral in the body (the body requires approximately 350 mg/day) and the stent is made of < 4.5 mg of magnesium. The alloy also has calcium antagonist and antiarrhythmic properties and, of importance, is not associated with any adverse allergic reactions.

To conclude, the development trend of DES is to realize completely elimination of negative effect of polymer or even scaffolds to human beings.