In the cardiovascular field, coronary artery calcification has always been a difficult point in treatment. Today, let's take a deeper look at the new technology for treating moderate to severe calcification lesions - shock wave balloon (IVL).
Analysis of the current status of coronary calcification
Incidence of coronary calcification
The incidence of coronary calcification is very high, and it is more common and serious in patients with diabetes, hyperlipidemia, and chronic kidney disease. The incidence is 50% in people aged 40-49 and 80% in people aged 60-69. Calcified lesions account for about 1/3 of all interventional treatments.
Calcified lesions affect the effect of interventional treatment
Before PCI: Angiography underestimates the severity of calcification, affects the formulation of treatment strategies, and fails to adequately pretreat.
During PCI: Affects stent delivery, damages coatings and drugs, and increases the risk of poor stent adhesion and asymmetry.
After PCI: Increases the risk of complications such as edge dissection, perforation, and the incidence of thrombosis and restenosis.
Challenges of vascular calcification
High Risk: Increased risk of serious adverse events, including flow-restricting dissection, perforation, and late embolism.
Vascular Wall Damage: Damage to the vascular wall may occur when treating calcified lesions.
High Cost: Low surgical success rate, multiple surgeries may be required.
Technical Complexity: Complex technology is used to treat complex cases, and the outcome is unpredictable.
IVL technology definition
Intravascular shock wave lithotripsy, also known as shock wave balloon technology, uses an extracorporeal device to transfer electrical energy to the transmitter, which generates "sonic pressure waves" to vaporize the liquid in the balloon, and uses the vaporized liquid to "beat" the calcification of the endothelium and media of the blood vessel through the air, while having no or little effect on the vascular tissue, increasing vascular compliance, thereby achieving the purpose of treatment.
History of IVL technology development
The development of IVL stems from the improvement and innovation of traditional interventional surgery. With the advancement of medical technology, the demand for the treatment of cardiovascular diseases such as coronary heart disease has increased, and IVL has come into being. The technology was approved for marketing in Europe in 2018, approved by the U.S. Food and Drug Administration in 2021, and approved for the treatment of coronary artery calcification in China in May 2022.
Comparison of IVL with common treatment technologies for coronary artery calcification
IVL has obvious advantages over traditional coronary artery calcification treatment technologies. Traditional treatments such as drug therapy, angioplasty, and stent implantation have limitations, and the treatment of calcified plaques is ineffective or difficult to operate. IVL can more accurately break up calcified plaques, reduce damage to surrounding tissues, have a lower risk of complications, and recover faster.
Advantages of IVL
Simple operation
The system is simple, intuitive, compact and portable, making complex calcification treatment procedures easier to control.
Accuracy
The shock wave is used to accurately break up calcified plaques to avoid damage to surrounding normal tissues.
Non-invasive
The surgery does not require a large incision, reducing postoperative pain and recovery time. Safety Safely ruptures intima and media calcification, with low risk of complications and a wide range of applications
Market situation of shock wave balloon therapy system
Shock wave balloon therapy system refers to a treatment method that selectively acts on the calcified lesions under the vascular intima and media by generating acoustic pressure waves through pulses in the balloon, so as to loosen the calcification without affecting the integrity of the vascular intima. Coronary artery calcification is one of the manifestations of coronary atherosclerosis, and has a certain relationship with dyslipidemia, age, obesity, inflammation, hypertension, etc. In recent years, with the acceleration of the aging of the population and the improvement of residents' living standards, coronary artery calcification has become one of the common complications of coronary heart disease. There are many patients with coronary artery calcification in my country, and the need for coronary artery calcification treatment is urgent. As one of the advanced treatment technologies, shock wave balloon has great potential for future market development
As an emerging track, the commercialization of shock wave balloon field has only been in recent years. At present, the number of companies that have deployed shock wave balloon market globally is increasing, including Shockwave Medical, Fast Wave Medical, Blue Sail Medical, Jiamuyao Medical, Jianshi Medical, etc. A number of domestic companies have also gathered in this field. In addition to Saihe Medical, Huihe Medical, Spectron Medical and Micro-Port Medical, Jianshi Medical, a domestic manufacturer, currently has a coronary pulse shock wave balloon treatment product that has been approved for marketing.
As an emerging vascular calcification treatment device, the shock wave balloon has the advantages of less trauma, strong applicability, and reduced complications in the clinical treatment process compared to rotational grinding treatment. With the increase in the application of shock wave balloons and the improvement of awareness, the market potential of shock wave balloons will continue to be released, and it is expected that IVL products will be commercialized in China in 2023. The potential IVL market for coronary artery disease will increase from 80 million yuan in 2023 to 790 million yuan in 2027.
As a pioneer in the field of medical device CDMO, SmartVein Medical Technology is committed to transforming the most cutting-edge scientific and technological achievements into practical clinical applications. The portable endoscope imaging system is a high-tech device that integrates advanced optical technology, electronic imaging technology, data processing and transmission technology. It uses advanced optical technology to obtain clear images of the human body; it converts optical signals into electronic signals through electronic imaging technology for collection, processing and display; it is also equipped with a data management system to facilitate the storage, retrieval and analysis of inspection data and images. Its design focuses on portability, compact structure, lightweight materials, convenient use in different scenarios, easy operation, quick start, and provides great convenience for medical examinations, helping doctors diagnose diseases more accurately.
Contact Us:
Website：www.smartveingroups.net
Tel：+86 17357337776
Email：chu@smartvein.com.cn
