Fuwai Hospital Unveils Direction-Adjustable Shockwave Balloon Catheter Patent

April 2024,Fuwai Hospital, Chinese Academy of Medical SciencesAdded one itemShockwave BalloonPatent disclosure. This patent is aDirectionally Adjustable Shockwave Balloon, to address the technical problem that existing shockwave balloons cannot freely adjust their orientation within the human body.

Clinically, intracoronary rotational atherectomy is commonly used to treat vascular calcification. However, this technique demands high operator expertise, hindering its widespread adoption, and carries a risk of complications such as vascular injury. Consequently, there is growing clinical anticipation for shockwave balloon technology, which offers enhanced safety and ease of use.

However, existing shockwave generation devices have certain limitations.If the intensity, range, and direction of the generated shock waves are difficult to control, it may lead to suboptimal therapeutic outcomes or cause damage to surrounding tissues.To address this pain point, the team incorporated axially configured bendable bimetallic strips and employed heating to actuate shape-memory alloy strips, enabling directional control of the shockwave balloon and thereby enhancing therapeutic efficacy.

Vascular calcification is a common pathological manifestation of blood vessels. Aging, atherosclerosis, and hypertension can all contribute to the development of vascular calcification. Although vascular calcification does not directly cause severe consequences for patients, it stiffens the vessel wall and reduces compliance, thereby leading to myocardial ischemia, left ventricular hypertrophy, heart failure, and an increased risk of thrombosis.

Currently, the most effective clinical treatment for vascular calcification is intravascular lithotripsy, which primarily uses low-pressure balloon dilation to disrupt superficial and deep calcification, thereby restoring vascular elasticity.

Balloons for the treatment of vascular calcification vary in type depending on their mechanism of action. There areNon-compliant balloons, scoring/cutting balloons, rotational atherectomy balloons, intravascular lithotripsy (IVL) balloons. Among them, shockwave balloons can address severe calcification and are safer, more effective, and easier to use.

Advantages and Disadvantages of Various Balloon Catheters

As an emerging sector, the number of companies globally positioning themselves in the shockwave balloon market has been increasing in recent years. Current participants in this sector includeShockwave Medical, Fast Wave Medical, Blue Sail Medical, Jiamuyao Medical, Jian Shi Medicaletc.

Industry Participant Landscape

In 2021, Shockwave Medical’s intravascular lithotripsy balloon catheter for the treatment of calcified peripheral artery lesions received CE marking in Europe and FDA approval in the United States, which alsoThe World’s First Approved Shockwave Balloon. In 2022, this balloon catheter also received approval from the National Medical Products Administration (NMPA) for market launch, officially entering the Chinese market.

The first domestically produced shockwave balloon is the C-Wave® Intravascular Shockwave Catheter and Generator System, independently developed by Zhonghui Medical of Huihe Group., which was approved for market launch in 2023. The introduction of this product marks a significant breakthrough in China's shockwave balloon technology, providing more treatment options for patients with cardiovascular diseases such as coronary heart disease.

In 2024, the Vesscrack intravascular lithotripsy balloon catheter, independently developed by Lepu Medical, was officially approved for market launch. According to publicly available information, the device features innovative designs in electrode configuration, acoustic pressure distribution, and intelligent display capabilities, enabling safe and effective improvement of vascular calcification. It is reported thatThis product is the second domestically produced counterpart to be launched in China and the third intravascular lithotripsy (IVL) product for coronary arteries to be marketed globally.

Currently, multiple domestically produced shockwave balloons have entered the clinical stage. For instance, Sonico-PX, China’s first domestically developed intravascular lithotripsy system for peripheral vessels, jointly developed by Academician Ge Junbo’s team at Zhongshan Hospital, Fudan University, and Puchuang Medical, initiated its registration clinical trial in 2021 and completed the enrollment of the first patient in December.