China's Dual Firsts! Tongling Bionics' Intra-Aortic Balloon Pump Catheter Kit Officially Obtains NMPA Registration

Recently, approved by the NMPA, Anhui Tongling Bionics Technology Ltd. has obtained Class III medical device registration for China's first intra-aortic balloon catheter kit (TL-IAB-30, TL-IAB-40). This marks another significant breakthrough for Tongling Bionics following the launch of China's first self-developed intra-aortic balloon pump, TL-IABP-100, in the first half of 2025. China's first self-developed IABP system has broken years of import monopoly and is expected to benefit numerous hospitals and patients in the future.

1. Clinical Applications and Guidelines

In recent years, the clinical application market for IABP in China has maintained a relatively rapid growth trajectory. Within the context of the high incidence of cardiovascular diseases, the demand for cardiac assist devices like IABP remains persistent. Geographically, developed regions such as Europe and America hold a significant global market share due to their well-established cardiovascular disease prevention and treatment systems and high adoption rates for advanced medical technologies and equipment. However, as the economic strength of developing countries grows and their medical infrastructure gradually improves, their market growth potential is considerable. In emerging Asia-Pacific countries like India and China, the demand for IABP is steadily increasing alongside rising cardiovascular disease rates and greater investment in medical resources. The global market size is expected to expand at an accelerated pace in the coming years.

The 2025 "Percutaneous Coronary Intervention Guidelines" provided a systematic update on the application strategy of IABP in PCI, further clarifying its indications and timing of use based on characteristics of Chinese clinical practice and the latest evidence-based medical evidence. The guidelines emphasize the core mechanism of IABP — inflating during ventricular diastole to increase aortic diastolic pressure and improve coronary perfusion, and deflating during systole to reduce left ventricular afterload — underscoring its irreplaceable value in treating high-risk patients.

Regarding indications and recommendation levels, the guidelines classify the following as Class I recommendations (C-EO evidence): STEMI complicated by cardiogenic shock (when vasopressors are ineffective or combined with acute left heart failure), STEMI with mechanical complications (e.g., papillary muscle rupture, ventricular septal rupture causing hemodynamic instability), and hemodynamic crisis during PCI. For extremely high-risk PCI patients (e.g., with a history of cardiogenic shock, severe heart failure, complex multi-vessel disease with LVEF <30%), routine use of IABP for mechanical circulatory support is recommended (Class IIa recommendation, C-EO evidence).

The timing of clinical application is divided into three categories: Prophylactic use is suitable for high-risk procedure patients, such as those with unprotected left main disease or severe multi-vessel disease combined with cardiac dysfunction, recommending pre-procedural insertion to maintain intraoperative hemodynamic stability; Rescue use addresses circulatory collapse during PCI caused by sudden coronary artery occlusion or malignant arrhythmia; Bridge therapy provides transitional support for patients awaiting cardiac surgery or transplantation. The guidelines specifically note that IABP can increase PCI success rates by 20%-30% in patients with severely impaired left ventricular function, with a lower complication rate compared to other mechanical circulatory support devices.

Compared to devices like ECMO and catheter-based axial flow pumps, the guidelines clearly state that IABP offers advantages such as ease of operation, fewer complications (40% reduced bleeding risk), and higher cost-effectiveness, recommending it as the preferred initial circulatory support strategy. For patients requiring stronger support, a combined IABP and ECMO strategy can be adopted, utilizing IABP to reduce left ventricular afterload and compensate for the limitations of ECMO used alone.

As the core consumable for IABP systems, the performance of the IAB balloon catheter is directly related to treatment efficacy and patient safety. Leveraging its talent advantages in the integration of medicine and engineering, Tongling Bionics has achieved multiple technological innovations through continuous exploration in structural design, balloon performance, and production processes of the balloon catheter. These innovations enable stable hemodynamic support for patients, meeting clinical demands for safety, precision, and reliability.

2. Optimized Structural Design

The balloon catheter primarily consists of a tip, balloon membrane, inner/outer tubes, and a Y-connector. The TL-IAB-30 and TL-IAB-40 feature a dual-lumen coaxial design: the inner lumen, used for fluid and guidewire passage, incorporates a stainless steel to balance flexibility, support, and bending strength; the outer lumen, used for helium delivery, is made of wear-resistant polymer to protect the inner lumen and enhance helium delivery efficiency. Additionally, the large-diameter central lumen provides continuous and clear arterial blood pressure waveforms, while the smooth and soft tip minimizes patient trauma caused by puncture or abrasion during procedures.

3. High-Performance Balloon Material

The balloon is made of medical-grade high-performance polyurethane, offering excellent flexural resilience, fatigue resistance, and abrasion resistance. It can withstand high-frequency continuous inflation and deflation cycles and endure persistent abrasion from most aortic calcifications. Simulation tests show that the balloons maintain excellent performance even after 5 million inflation-deflation cycles. The high-performance polyurethane composite material also exhibits good biocompatibility, allowing for extended use in patients. The balloon surface is treated with a cured hydrophilic coating process, significantly reducing friction and ensuring smoother implantation.

4. Advanced Production Process

The balloon must possess extremely high burst pressure resistance while also being thin-walled, uniform, and softly folded, posing significant challenges to the production process. Relying on advanced automated production equipment and manufacturing techniques, the TL-IAB-30 and TL-IAB-40 have significantly enhanced overall balloon performance based on comprehensive innovation of traditional balloon forming technology. Through high-precision multi-axis linkage control systems and intelligent molding platforms, uniform control of balloon wall thickness and consistency in folding morphology are achieved, ensuring the product's burst pressure reliability under extreme thin-wall conditions. Simultaneously, the adoption of laser micro-welding and visual alignment processes further enhances the sealing performance and mechanical stability of the interface structure, successfully overcoming the process challenges associated with semi-compliant materials in high-precision balloon molding. This demonstrates the company's leading technical prowess in the field of high-end medical devices.

Thanks to the aforementioned innovations, the Tongling Bionics TL-IAB-30 and TL-IAB-40 balloon catheter offer excellent intravascular deliverability, are easy to operate, safe, and durable, and can seamlessly integrate with the TL-IABP-100 pump. Concurrently, the company is actively advancing the development of new balloon catheters to better meet clinical needs and contribute to enhancing China's capacity for treating critical and severe illnesses.