Recently, the National Medical Products Administration approved the registration applications for two innovative products, the "Proton Therapy System" of Maisheng Medical System Company (hereinafter referred to as Maisheng Medical) and the "Cardiac Pulse Electric Field Ablation Device" of Shanghai Hongtong Industrial Co., Ltd. (hereinafter referred to as Shanghai Hongtong).

Maisheng Medical, the first product to be launched in China
Maisheng Medical was founded in 2004 and is headquartered in Littleton, Greater Boston, Massachusetts, USA. We specialize in the research, development, production, installation, and service of miniaturized proton therapy equipment for cancer treatment, with branch structures in Europe and Asia. We are a leader in the field of miniaturized proton therapy. The miniaturized proton radiotherapy system developed based on its own core technology has unique advantages such as good clinical efficacy, high integration level, small footprint, and low overall customer ownership cost.

At present, Maisheng Medical has advanced proprietary intellectual property rights in HYPERSCAN ultra high speed pencil beam scanning technology and Adaptive Aperture adaptive multi leaf grating technology. Its core product S250i series is the preferred solution in the field of proton therapy, achieving complete independent research and development from core components to key algorithms. So far, the proton therapy system independently developed by Maisheng Medical has treated over 10000 patients worldwide.

It is worth mentioning that the proton therapy system approved this time is China's first miniaturized integrated single chamber proton therapy system. The product consists of an accelerator subsystem and a treatment subsystem, where the accelerator subsystem includes an ion source, a magnet unit, an RF unit, a vacuum unit, a water cooling unit, and a beam extraction unit; The treatment subsystem includes a rotating gantry, treatment head, image guidance and registration system, treatment console, radiation therapy planning system, laser positioning system, etc. By providing proton beams for radiation therapy, it is suitable for solid malignant tumors and benign diseases such as trigeminal neuralgia throughout the body.

The proton therapy system adopts an integrated superconducting proton accelerator combined with an integrated rack design, which has the characteristics of small size. It adopts industry-leading HYPERSCAN ultra high speed pencil beam scanning technology and unique Adaptive Aperture adaptive multi leaf grating technology, which can deliver the required dose to the target area in a shorter time, while reducing the edge penumbra of the target area to within 3mm, providing precise and efficient proton therapy. The HYPERSCAN ultra high speed pencil beam scanning technology can complete energy layer switching within 50 milliseconds, providing fast and stable proton intensity modulated radiation therapy (IMPT) dose distribution for adjacent important organs or easily mobile tumor targets, ensuring the safety and efficacy of treatment.

Moreover, the system integrates advantages such as low cost, small size, high integration, and low energy consumption, greatly shortening the cycle from project design to system installation and debugging to clinical treatment implementation. This enables more medical institutions to quickly implement proton therapy technology within an affordable cost range, giving more patients the opportunity to benefit from advanced proton therapy and greatly improving its accessibility.

Shanghai Hongtong, domestic power gradually rising
Shanghai Hongtong was founded in 1998 and is a high-tech enterprise based on universities, focusing on the industrialization of high-tech medical device achievements. It specializes in the research and manufacturing of high-value consumables related to cardiovascular and cerebrovascular interventions. In 2014, it was controlled by Huitai Medical.

After nearly 10 years of continuous research and development investment, Shanghai Hongtong launched the HT Viewer highly integrated electrophysiological mapping system in 2021, which includes "electrophysiological recorder+programmable stimulator+3D navigation", breaking through the bottleneck problem of long-term lack of high-end equipment matching and low consumables technology in the domestic electrophysiological field. In the three years since its launch, it has gained high clinical recognition. This 3D electrophysiological mapping system is the exclusive magneto electric dual positioning system among domestic brands, and the first international product that integrates a physiological recorder, stimulator, and 3D mapping system.

The approved cardiac pulse electric field ablation device consists of a host, isolated power supply, foot switch, and accessory cables. The accessory cables include: 3D positioning device connection cable, serial computer interface cable, impedance monitoring connection cable, and grounding cable. This product is used in conjunction with disposable pulsed electric field ablation catheters and is mainly used for the treatment of atrial fibrillation.

Moreover, the cardiac pulse electric field ablation device adopts pulse electric field ablation technology, which selectively treats the tissue at the lesion site by controlling the energy of the pulse electric field, causing irreversible electroporation damage to myocardial cells, thus achieving the therapeutic goal. This technology can effectively reduce the risk of thermal damage to surrounding normal tissues, benefiting more patients with drug-resistant, recurrent, symptomatic, and paroxysmal atrial fibrillation.

According to Frost&Sullivan's prediction, the PFA market size in China is expected to reach 1.3 billion yuan by 2025 and maintain rapid growth; By 2032, it is expected to increase to 16.3 billion yuan, with a compound growth rate of 43.73%. The proportion of PFA market size in the overall market size of electrophysiological devices in China is expected to continue to rise, increasing from 8% in 2025 to 39% in 2032.

Although the current domestic electrophysiological market is still dominated by such giants as Medtronic, Johnson&Johnson, Abbott, and Boko, the domestic emerging forces are gradually rising, and more and more local innovative machinery enterprises are deploying on the pulse ablation track.

Conclusion
Nowadays, an increasing number of domestic innovation forces are emerging, and innovation, as the primary driving force, is continuously leading the continuous improvement of China's medical equipment level. With the acceleration of China's medical device innovation, more innovative products will emerge in the future, and the Chinese medical device industry is continuously accelerating towards the goal of high-quality development.

Source: https://news.yaozh.com/archive/44694.html