On October 19, 2021, saihe medical independently developed the first coronary artery shock wave lithotripsy system in China was completed by the team of Professor Li Yan of the Department of Cardiology in Tangdu Hospital of air force military medical university, and the operation was a complete success, fully demonstrating the safety and excellent clinical effect of the innovative device.
According to reports, the first clinical trial enrolled patients are women, and their coronary CTA and coronary angiography suggest that 80% of the severe stenosis of the proximal descending branch of the anterior descending branch is severely stenosis with severe calcification. Considering that the patient belongs to the middle ring calcification and local eccentric calcification, other methods of treating calcification may not meet good expectations, and Professor Li Yan's team used the coronary shock wave lithotripsy system for treatment of the patient.
<h1 class="pgc-h-arrow-right" data-track="5" > cutting-edge treatment solutions, leading the way in epoch-making technology</h1>
The coronary shock wave lithotripsy system independently developed by Saihe Medical consists of two parts: shock wave coronary balloon catheter LiqMagic C14 and intravascular shock wave therapy instrument ISL100 Pro. After the shock wave coronary balloon catheter and the intravascular shock wave therapy instrument are connected, the host of the intravascular shock wave therapy instrument can be controlled to start or stop the intravascular lithotripsy treatment through the control button of the operation handle, which has good safety, convenience and reliability. The distal and proximal ends of the balloon are marked with a developing ring for precise positioning by the doctor.
Professor Li Yan said: "From the connection of the overall system, the passage of the shock wave balloon and the treatment effect of the middle layer and eccentric calcification, the coronary shock wave lithotripsy system performed well during the operation, and the treatment of a discharge cycle (10 seconds) saw that the calcified stenosis was easily opened. After the stent implantation, the expansion is ideal, there is no obvious residual narrowness, and it is very easy to overcome the hard fortress, and the good effect has been unanimously recognized by all colleagues in the Department of Cardiology. ”
Mr. Liu Bin, Chairman of Saihe Medical, said: "We are very pleased to see that this clinical study can successfully complete the first patient enrollment. The emergence of the coronary shock wave lithotripsy system has provided an efficient and safe solution for calcified plaques that interventionists have previously been helpless and unable to handle, significantly reducing intraoperative risks, enabling implanted stents to reach the maximum lumen and fully expanding the adherent. As a local medical device innovation enterprise in China, Saihe Medical will continue to be committed to the technological innovation and clinical application of cardiovascular implant interventional devices, and we believe that intracorular shock wave lithotripsy technology will bring good news to patients with calcified lesions. ”
<h1 class="pgc-h-arrow-right" data-track="29" > deeply cultivate independent innovation equipment and overcome the "last bastion" of coronary artery lesions</h1>
Coronary heart disease has always seriously threatened the health of the majority of patients, and with the increasingly severe trend of population aging, its incidence has also increased year by year. Coronary artery calcification lesions often run through a variety of complex coronary heart disease lesions, accounting for about 20-30% of them. Advanced age, diabetes and renal insufficiency are all risk factors for coronary artery calcification, and coronary calcification seriously affects the treatment and prognosis of coronary heart disease.
Coronary artery calcification lesions are very tricky lesions in interventional treatment and are called "the hardest bones" or "the hardest bastions". Coronary calcification has become a bottleneck in the treatment of cardiovascular disease. A 2014 meta-analysis study published in BMJ confirmed that coronary calcification was an independent predictor of poor prognosis, with significantly higher mortality in severely calcified patients. Ordinary balloons are difficult to dilate satisfactorily, easy to rupture of blood vessels after high pressure expansion, low instrument pass rate, high incidence of dysplasmation after stent implantation, and high perioperative complications, often leading to perioperative myocardial infarction and increased mortality. Traditional methods of treating calcified plaques, including high-pressure balloons, cut balloons, spin-incision/spin milling of plaques, have limitations and can only handle superficial calcifications of the intracular lining of the vessels, and are "helpless" for mesodiacalification, eccentric calcification nodules, or severe calcifications.
In this case, Saihe Medical adopted a new system architecture and successfully developed the first independent coronary shock wave lithotripsy system in China. Unlike traditional calcification treatment techniques, the coronary shock wave lithotripsy system combines acoustic calcification fracturing techniques with balloon catheters. The shock wave balloon has built-in several miniaturized and parallel acoustic pressure wave generators, which are delivered to the calcification lesion through the balloon catheter platform, and the balloon can release intermittent acoustic pressure waves to the calcified lesion when the balloon is expanded at low pressure, and the superficial and deep calcification plaques of the vascular cavity can be efficiently and safely destroyed through unfocused, pulsed mechanical energy, thereby significantly improving vascular compliance. "Coronary Artery Calcification Lesion Diagnosis and Treatment of Chinese Expert Consensus 2021" pointed out that intravascular shock wave lithotripsy not only has an effect on superficial calcification, but also is the only technology in the industry that has a therapeutic effect on deep calcification, which provides a new choice and a powerful "weapon" for the treatment of coronary artery calcification lesions, and is expected to become the "terminator" of coronary artery calcification lesions.
>>>> about Saihe Medical
Saihe Medical is a high-tech enterprise that develops and produces active vascular implant interventional medical devices, the main products include shock wave balloon catheters, ultrasonic catheters and other active interventional high-value medical consumables, covering coronary artery disease, peripheral vascular disease and structural heart disease and other cardiovascular and cerebrovascular clinical fields. The company was founded in 2020, headquartered in Shenzhen, the company's product development team from well-known medical devices and ICT companies, in the medical sensors, vascular interventional devices and host systems and other aspects of rich design and development experience, we will maintain continuous technological innovation in medical sensor chip technology, promote the large-scale application of high-value consumables products based on new medical sensors in the field of medical and health, continue to create value for doctors and patients, and be a smart medical enabler.