NIE 2024 | Peng Keh Medical Weng Yulin: Differentiated Exploration of Interventional Balloons

The following are the key points of Weng Yulin's speech:

Weng Yulin pointed out that in the medical device market, the differentiated strategy of balloon products is gradually becoming a key measure to cope with the normalization and homogenization of centralized procurement. With the intensification of market competition, traditional products struggle to stand out in the fierce environment due to issues such as insufficient technological innovation and limited patent protection. Therefore, differentiation is the key to success. By exploring differentiation in products, fields, and strategies, it is possible to effectively promote products from homogenized competition and remain invincible in the fierce market competition. Manufacturing industry-leading products with unique technology is an important path for enterprises to pursue innovation and achieve sustainable development.

In terms of policy differentiation, through reasonable pricing strategies and international cooperation, it is not only possible to rapidly enhance the market competitiveness of products but also to leverage external resources for technology introduction and overseas market development. In the exploration of differentiation in application areas, attention should be paid to some overlooked 'small pools with big fish' markets, such as the dialysis access field. The annual increase in new uremia patients in China has significantly accelerated, breaking through 1 million for the first time at the end of 2022, a 3.5-fold increase compared to the total number of dialysis patients in 2011. With the increase in the number of dialysis patients, the number of hemodialysis access surgeries accelerated to over 70,000 in 2020 and is expected to increase to 994,500 by 2030. This market has great potential and relatively less competition. By deeply cultivating these areas, it is possible to effectively avoid homogeneous competition in the mainstream coronary balloon market.

In terms of product differentiation, the development of balloon technology has evolved from traditional balloon PTA (POBA) to drug-coated balloons (DCB) and focused-focal-pressure balloons (FFB). Each generation of technology has innovated and improved upon the shortcomings of the previous one. Although early balloon PTA technology played an important role in vasodilation, its high restenosis rate and vascular wall damage limited its efficacy. The advent of bare-metal stents (BMS) effectively reduced the incidence of restenosis, but there were issues such as multi-layer stents, poor adaptability to small vessels, and antiplatelet contraindications for device implantation. Drug-eluting stents (DES) further reduced in-stent restenosis through drug release, but they have not completely solved the problems brought about by mechanical implantation, and there is no significant difference in long-term survival rates compared to bare-metal stents. The introduction of drug-coated balloons (DCB) eliminates the need for stent implantation, thereby reducing the risk of mechanical implantation and effectively preventing restenosis through drug release, marking a significant advancement in technology. Focused-focal-pressure balloons (FFB) further improve the precision and safety of vascular preparation on this basis, reducing the risk of dissection.

Compared to conventional balloons, when the pressure focused balloon dilates fibrotic lesions, it cuts off the continuity of the fibrotic lesions through a cutting element, while reducing the phenomenon of elastic recoil. This type of balloon can reduce plaque extrusion and vascular stretching during dilation, and lower the incidence of dissection. In addition, it can form regular cracks within the vessel, facilitating drug balloon application. For example, the Dingke Incised Balloon, compared to other products, adopts a nickel-titanium coil wrapped design to ensure high safety during delivery; it has directional incisions that can achieve controllable dilation effects and form a folded shape after dilation; it also has strong retraction capabilities, significantly improving operational safety and effectiveness. The DK Score Coronary Incised Balloon significantly outperforms similar imported products in terms of immediate lumen gain, especially in the treatment of in-stent and off-stent restenosis lesions, showing better dilation effects and higher device success rates.