The incidence of coronary heart disease in China is increasing in recent years. In 2019, the number of PCI procedure, the gold standard treatment of coronary heart disease in China exceeded 1 million for the first time, but there still exists room for 2-3 times growth according to the number of PCI cases per capita in Europe, America, and Japan. Influenced by the pandemic and VBP of coronary stents in recent two years, the growth of PCI operations in the top tertiary hospitals in first-tier cities has been slow, while hospitals in other provinces which lost patients in the past have a new wave of surgery growth.
The problem this industry needs to consider is promoting more doctors, who are young or based in non-first-tier cities, to carry out more PCI operations, deal with complex lesions better, and practice precise PCI operations.
Complex coronary artery diseases include CTO lesions, left main coronary artery disease(‘LMCAD’), multi-vessel coronary artery disease, severe calcification diseases, etc. Calcification lesions appear in a lot of different complex lesions, which increases the total difficulty of coronary interventional treatment. It is one of the most important challenges faced by cardiovascular intervention doctors. The outcome of severe atherosclerosis is vascular calcification. Calcifications will exist on the surface, middle, and deep layers of the artery wall, and make it more difficult for intervention vehicles to expand the artery under safe pressure than in mild atherosclerosis.
Figure: Vascular Calcification
Coronary artery calcification(‘CAC’) frequently appeared in atherosclerosis. Some scientists also stated that atherosclerosis might always be accompanied by calcification, and moderate and severe calcifications need high industry attention. Calcification can be diagnosed by coronary CT scan, angiography, intravascular ultrasound (IVUS), and optical coherence tomography (OCT). In practice, the main diagnosis method is still angiography.
Among the 6,855 patients with acute coronary syndrome (ACS) who had PCI surgery and are monitored by the ACUITY and HORIZONS-AMI studies, the proportion of moderate and severe calcification was 32%, of which 26.1% were moderate calcification and 5.9% were severe Calcified lesions.
Figure: Distribution of Vascular Calcification in ACS patients
Moderate and severe calcification not only increases the difficulty of PCI surgery, introducing more vascular pretreatment tools, but also significantly affects the postop health of patients. The above studies indicated, for patients with moderate and severe calcification and taking operations, cardiogenic death, myocardial infarction, stent thrombosis, target lesion revascularization, and other cardiovascular disease were more likely to happen in one year.
Figure: The Incidence of Adverse Events in Patients with Calcification at 1 year after Surgery
Through multivariate analysis, moderate and severe calcification is an independent variable that predicts the diagnosis of stent thrombosis and ischemic target lesion revascularization within 1 year.
Figure: Independent Control Variables of Cardiovascular Disease.
Although in the above-mentioned study, some calcified lesions have received pretreatment like rotational atherectomy(‘RA’), the surgical outcome after 1 year cannot be changed.
The currently available treatment methods for calcification include non-compliant balloons, cutting balloons, RA, excimer laser coronary angioplasty(‘ELCA’) as well as intravascular lithotripsy(‘IVL’) that will be launched in China, etc.
Figure: Comparison of Main Treatment Techniques for Calcification
In China, the commonly used treatment practice is cutting balloons and RA, which are suitable for mild to moderate and moderate to severe calcification, respectively.
Figure: Common Treatment Strategies
The cutting balloon can effectively cut calcification with thickness <535μm. Nevertheless, it is not recommended to use the cutting balloon for grade III~IV calcifications. Excessive pressure when using the cutting balloon may cause the blade incarcerated and to be retracted with difficulty. During the operation, it is necessary to avoid the use of balloons on the LMCAD area because of the slow pressure withdrawal. In addition, it can only act on the calcification foci on the surface of the blood vessel rather than the middle and deep part of the blood vessel due to the property of the cutting balloon.
Coronary rotational atherectomy (CRA), based on the theory of “differential cutting”, uses olive-shaped rotational atherectomy heads with diamond particles to selectively remove calcified or fibrotic arteriosclerotic plaques. Due to the high requirements of RA, the incidence of complications is also higher than that of ordinary intervention. Only some tertiary hospitals that met severe calcification would apply CRA. The main complications of rotational atherectomy include coronary artery spasm, dissection, perforation, rupture of the rotational atherectomy guidewire, and incarceration of the atherectomy head. The complicated operation and complications limit the wide application of CRA. Similarly, rotational atherectomy can only treat the calcification foci on the surface of the blood vessel, and cannot fully recover elasticity of the blood vessel due to its property.
As a new technology, the intravascular shockwave system works differently from the traditional calcification treatment. It could release pulsed acoustic waves pressure to the lesion when the balloon is expanded under low pressure. The operation destroys the surface and deep calcification efficiently and safely. Besides, lithotripsy has a short learning curve and can be widely applied.
The treatment has advantages for LMCAD, angular disease, incomplete stent expansion, circular and eccentric calcification, and surface and deep calcification. Chinese Experts Consensus on the Diagnosis and Treatment of Coronary Artery Calcification Lesions called it ‘终结者(terminator of coronary artery calcification)’, expressing the high expectation of coronary artery doctors to the new technology.
Picture: US company Shockwave Medical INC. Intravascular shock wave lithotripsy system
Many research proved that the shockwave IVL balloon for coronary artery calcification is safe and effective. US Company Shockwave Medical has completed 4 clinical trials and published more than 100 academic papers for the technology. The recent published one-year result of the DISRUPT CAD III trial on TCT 2021 shows that among all patients with severe coronary calcification, MACE and cardiac death within one year are 13.8% and 1.1%, respectively. The performance is better than that of ACUITY and HORIZONS-AMI studies.
In addition, this technology is also suitable for peripheral vascular or aortic valve calcification. Shockwave Medical has already earned FDA 510(K) clearance for treating peripheral vascular calcification, and started FIM trial for treating aortic valve calcification.
Shockwave Medical, the technology owner, has become the listed medical device company with the highest market value in recent years. The emergence of clinical data and the PMA approval for coronary indications in February 2021 results in a continuously increasing stock price. The market value has risen by more than 10 times within 3 years. The latest market value is around 7 billion USD.
Chart: US Shockwave Medical INC. Stock Price Trend
So far, Chinese company Genesis MedTech Limited has signed a licensing-in agreement with Shockwave Medical to introduce this disruptive technology into China’s market. Based on the strongly validated trial data, it is estimated that the technology will be approved by NMPA in the first half of 2022.
Chinese medical companies are highly optimistic about the booming IVL market. Both traditional disposable manufacturers and developing active intervention companies would like to enter the market and gain profit. Right now, there are at least 4 companies in this sector that have entered the clinical trial stage.
SONOSEMI
SONOSEMI, founded in 2020 and headquartered in Shenzhen, is a high-tech medical device company developing active intravascular intervention devices. The R&D team consists of people from well-known medical device or ICT companies. SONOSEMI is the first domestic company to start the IVL clinical trial for coronary artery calcification, and it completed its first patient enrollment on October 19th, 2021.
Spectrumedics
Spectrumedics, founded in 2019 and headquartered in Shanghai, focuses on combining active technology and minimally invasive heart/blood interventional treatment. Its R&D team is based in Singapore. Spectrumedics has completed both first peripheral artery and first coronary artery clinical patient enrollment of its IVL system.
HuiHe Healthcare
Hui Healthcare, a wholly-owned subsidiary of HuiHe Healthcare, was established in August 2020 and is located in Suzhou BioBay Park. The company engaged in the R&D and production of active cardiovascular medical devices. Hui Healthcare has completed its first peripheral artery clinical patient enrollment of its IVL system in November 2021.
Peijia Medical
TaurusWave system, self-developed by Peijia Medical, is an innovative active device targeting heart valve calcification. Peijia Medical is the first domestic company to apply shockwave technology in the TAVR procedure. According to the company, TaurusWave has already started its FIM trial.
Chinese precise PCI and non-implantation intervention market will enter the rapid development stage. The attribution of PCI surgery growth will be moved from the top-tier hospitals to hospitals in municipals and towns. The public expects treatment tools for complex diseases, like IVL, can help improve the prognosis of patients and help Chinese PCI surgery reach a new level.
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