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https://www.smartballoon.net/Intravascular-Lithotripsy-IVL-An-Innovative-Tool-in-Cardiovascular-Treatment.html

In the field of cardiovascular medicine, coronary artery calcification has always been a challenging area to treat. Today, let's delve into the new technology for treating moderate to severe calcified lesions – the Intravascular Lithotripsy (IVL).

I. Analysis of Coronary Calcification Status

1. Incidence of Coronary Calcification

The incidence of coronary calcification is high, especially in patients with diabetes, hyperlipidemia, and chronic kidney disease. The rate is 50% in the 40-49 age group and 80% in the 60-69 age group. Calcified lesions account for about one-third of all interventional treatments.

2. Calcified Lesions Affect the Effectiveness of Interventional Treatment

– Before PCI: Angiography underestimates the severity of calcification, affecting the formulation of treatment strategies and inadequate pre-treatment.

– During PCI: Affects stent delivery, damages the coating and drugs, increasing the risk of poor stent apposition and asymmetry.

– After PCI: Increases the risk of complications such as edge dissection, perforation, and the occurrence of thrombosis and restenosis.

3. Challenges of Vascular Calcification Lesions

– High Risk: The risk of serious adverse events increases, including restricted blood flow dissection, perforation, and long-term embolism.

– Vascular Wall Injury: Handling calcified lesions can cause damage to the vascular wall.

– High Cost: Low surgical success rates may require multiple surgeries.

– Technical Complexity: The use of complex techniques to handle complex cases with unpredictable outcomes.

II. Definition of IVL Technology

Intravascular Shockwave Lithotripsy, or intravascular lithotripsy technology, utilizes an external device to transmit electrical energy to a transmitter, which generates an "acoustic pressure wave" that vaporizes the liquid inside the balloon. This process "taps" the calcification in the intima and media of the blood vessels without or with minimal impact on the vascular tissue, increasing vascular compliance, thus achieving the treatment goal.

III. 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 and the increasing demand for the treatment of coronary heart disease and other cardiovascular diseases, IVL was born. This technology was approved for marketing in Europe in 2018, by the U.S. Food and Drug Administration in 2021, and in China for the treatment of coronary artery calcification in May 2022.

IV. Comparison of IVL with Common Coronary Artery Calcification Treatment Techniques

Compared with traditional coronary artery calcification treatment techniques, IVL has distinct advantages. Traditional treatments such as drug therapy, angioplasty, and stent implantation have limitations and are not effective or difficult to operate on calcified plaques. IVL can more accurately fragment calcified plaques, reduce damage to surrounding tissues, have a lower risk of complications, and faster recovery.

Technology	Principle	Disadvantage
Shockwave Technology	Releases non-focused, circumferential, and pulsed shockwaves to the lesion site to fracture both superficial and deep calcified plaques, improving vascular compliance	IVL balloons have poor deliverability, requiring assistance from other pre-treatment methods; there are limitations on the number of times a lesion can be treated
Non-compliant Balloon	High-pressure pump inflates the balloon, causing multiple longitudinal micro-tears in the narrowed area to achieve dilation	Excessive pressure dilation can lead to vascular damage
Scoring Balloon	Uses scoring pressure to plastically shape the plaque at lower operating pressures	Requires special usage conditions, mainly for mild to moderate calcification, and requires operator training
Rotational Atherectomy/Cutting	Uses a high-speed rotating burr to grind down calcified plaques to create new channels	Highest risk of coronary artery dissection and perforation; complex operation, with many complications; difficult to treat deep calcification
Laser Ablation	Excimer laser emits high-energy UV pulses, causing cells to vaporize water and increase internal temperature, leading to tissue disintegration

V. Advantages of IVL

1. Simplicity: The system is simple, intuitive, compact, and portable, making the complex calcification treatment process more manageable.

2. Precision: Utilizes shockwaves to precisely fragment calcified plaques, avoiding damage to surrounding normal tissues.

3. Non-Invasive: The surgery does not require large incisions, reducing postoperative pain and recovery time.

4. Safety: Safely fractures the intima and media calcification with a lower risk of complications and a broad range of applications.

VI. Intravascular Lithotripsy Treatment System and Market Situation

The intravascular lithotripsy treatment system refers to a method that uses pulses within the balloon to generate acoustic pressure waves, selectively acting on calcified lesions beneath the intima and media of blood vessels, causing calcification to loosen without affecting the integrity of the vascular intima. Coronary calcification is one of the manifestations of coronary atherosclerosis and is related to dyslipidemia, age, obesity, inflammation, hypertension, etc. In recent years, with the acceleration of population aging and the improvement of living standards, coronary calcification has become a common complication of coronary heart disease. China has a large number of coronary calcification patients with an urgent need for treatment, and intravascular lithotripsys, as one of the advanced treatment technologies, have great market development potential in the future.

As an emerging track, the commercialization of intravascular lithotripsys has only occurred in recent years. Currently, the number of companies globally deploying intravascular lithotripsys is increasing, including Shockwave Medical, Fast Wave Medical, Blue Sail Medical, Jia Muyao Medical, and Jianshi Medical. In this field in China, a group of companies has gathered, including Saihe Medical, Huihe Medical, Puchuang Medical, and MicroPort Medical, among which Jianshi Medical is the only manufacturer with an approved coronary intravascular lithotripsy treatment product.

Intravascular lithotripsys, as an emerging vascular calcification treatment device, have the advantages of less trauma, strong applicability, and reduced complications compared to rotational atherectomy. With the increasing application and recognition of intravascular lithotripsys, the market potential of intravascular lithotripsys will continue to be released. It is expected that the IVL product will be commercialized in China in 2023. The potential IVL market for coronary artery disease will increase from 0.8 billion yuan in 2023 to 7.9 billion yuan in 2027.

VII. Simvida Shockwave Host Solution

SmartBalloon Medical is committed to promoting the development and innovation of medical technology and plays an important role in the application and promotion of intravascular lithotripsy technology. It provides professional equipment and technical support to ensure that IVL technology is safely and effectively applied in clinical treatment, bringing better treatment outcomes and quality of life to patients.

In summary, the intravascular lithotripsy (IVL) is an important innovative technology in the field of cardiovascular medicine, bringing new breakthroughs in the treatment of coronary artery calcification. SmartBalloon Medical will continue to strive to provide more advanced medical technology popularization and high-quality medical services.

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