A major breakthrough in interventional therapy for heart valve disease and an innovative progress in the field of interventional non-implant valve repair for calcific aortic stenosis: On 19 October, 2021, Peijia Medical Limited (Peijia Medical) completed the first case of the world’s first in man (FIM) clinical trial of in-house developed TaurusWave® lithotripsy valvuloplasty system, in the Second Affiliated Hospital Zhejiang University School of Medicine. The procedure was successfully completed by the medical team led by Professor Wang Jian’an.
The patient was 66 years old, female, suffering from severe aortic valve stenosis. Pre-procedure imaging examination indicated aortic valve calcification (severe calcification HU545: 1155 mm3), tricuspid aortic valve with aortic valve area of 0.56 cm2, mean pressure gradient of 42 mmHg and aortic valve peak velocity of 4.33 m/s. The left coronary orifice of the patient was low and her valve leaflets were redundant, while the inner diameters of Valsalva sinus, STJ, and the ascending aorta were small. Given these conditions, If TAVR were performed, there would be a high risk of left coronary orifice blockage and delayed coronary occlusion. Taking both the cardiology team’s evaluation and the patient’s intention into consideration, TaurusWave® lithotripsy technology was adopted for treatment. There was no pacing during the operation, and no thrombus was seen in the cerebral protection system after the operation. Immediately after the procedure, the pressure gradient dropped by 50%, the aortic valve peak velocity decreased by 20%, and the aortic valve area increased by 40%.
Different from the traditional treatment of valve calcification stenosis, TaurusWave® is an innovative non-implant based transcatheter solution. Benefiting from the composite mechanical effect brought by shock waves, the procedure can soften calcification on valve leaflets without damaging soft tissues. TaurusWave® lithotripsy valvuloplasty system is in-house developed by Peijia Medical to deal with calcific aortic stenosis, which revolutionarily introduced shock wave technology into the treatment. A number of patent applications have been filed for the unique multi-model electrode design. Different from ultrasound, shock waves attenuate less in the human body and cause far less thermal damage to human tissues. It is a more efficient and safer calcification remodeling technology.
TaurusWave® system can be aligned by its specially designed balloon. When the balloon is dilated, it can precisely and directionally release pulsed shock wave, achieving the result of softening the calcification of shallow and deep lesions in a safe and efficient way. The semi-compliant balloon material, with special 1D and 3D models and multi-size designs for bicuspid and tricuspid valves, enables the TaurusWave® system to adapt to a wider range of valve anatomy and more effectively transmit shock wave energy to calcified lesions, thereby improving the mobility of the valve leaflets and hemodynamics.
Professor Wang Jian’an from the Second Affiliated Hospital of Zhejiang University School of Medicine holds TaurusWave® system in high regard: “TaurusWave® together with us has taken an important step in exploring the field of using shock wave technology in the treatment of valve calcification. The shock wave treatment has a relatively high clinical significance for young patients who are not suitable for conventional surgery therapy or implant-based interventional treatment. The improvement of hemodynamics resulted from the calcification remodeling procedure may also be beneficial to the subsequent treatments. We are looking forward to seeing more promising clinical value brought in by this innovative technology in the clinical feasibility research.”
Dr. Zhang Yi, Chairman and CEO of Peijia Medical, said: “Currently, calcific valve disease is still a characteristic of Chinese valvular disease patients, and it is also a clinical problem that needs to be solved urgently. TaurusWave® is a new treatment technology for heart valve calcification，an important and innovative contribution from Peijia Medical to ‘Invented in China’. We believe that TaurusWave® will become another powerful weapon to deal with heart valve calcification lesions in the near future. Peijia Medical’s innovative products will bring in long-term benefits to patients around the world.”
With the acceleration of population aging in China, heart valve disease has become a major cardiovascular disease. Malignant progression of severe aortic stenosis disease, in particular, seriously endangers the lives of patients. Considering the high heart valve calcification degree among Chinese patients, the emergence of TaurusWave®’s non-implant calcification remodeling technology provides a brand-new option for the treatment of calcified lesions. The successful completion of this procedure marks the official start of the world’s first in man (FIM) clinical trial of TaurusWave® led by Professor Wang Jian’an from the Second Affiliated Hospital of Zhejiang University School of Medicine as the principal investigator, which places a foundation for a wider clinical application. It is hoped that the TaurusWave® lithotripsy valvuloplasty system will benefit more patients with calcific valve disease.
