The MissilEX® Intracranial Thrombectomy Stent System, supported by CCRC Medtech’s full-cycle clinical trial services, has recently received marketing authorization from China’s National Medical Products Administration (NMPA). This milestone not only represents a major advancement in neurointervention but also redefines treatment paradigms for acute ischemic stroke (AIS), demonstrating CCRC Medtech’s technical expertise in high-risk medical device CRO services.
End-to-End CRO Services Accelerate Innovative Product Commercialization
Throughout the development and approval process of MissilEX®, CCRC Medtech provided full-cycle clinical trial services that proved instrumental in accelerating the product’s path to market. The company’s team demonstrated exceptional professionalism in clinical trial design, efficient multicenter project management, and rigorous data analysis. Facing the complexities inherent in clinical trials for high-risk devices like thrombectomy stents, CCRC Medtech leveraged its extensive experience in neurointervention to quickly mobilize its network of expert resources and establish deep collaborations with leading clinical institutions. By implementing scientifically sound trial protocols and maintaining strict quality control at every stage, the team ensured data authenticity and reliability, ultimately delivering impeccable clinical evidence that significantly contributed to the product’s swift regulatory approval.
Breakthrough Design with Demonstrated Clinical Value
The MissilEX® stent system incorporates several innovative design features including a unique open-close loop hybrid structure, helical outer wings, distal tapered ends, and full-body radiopacity. These technological advancements collectively enhance surgical success rates, particularly demonstrating superior performance in vessel wall apposition within tortuous anatomy and thrombus capture efficiency. Clinical trial data confirmed the device’s significant advantages in first-pass recanalization rates while effectively reducing risks of distal embolization, thereby providing clinicians with a safer and more effective treatment option for AIS patients.
Setting Industry Benchmarks Through Excellence
CCRC Medtech has established itself as an industry leader through its specialized team of international regulatory experts and clinical operations professionals who possess extensive cross-cultural project management experience. The company’s deep understanding of regional differences in medical device regulations and clinical practice standards enables it to develop customized localization strategies that minimize compliance risks for device manufacturers. With a service system that spans the entire product lifecycle and is supported by a robust network of expert resources, CCRC Medtech offers end-to-end professional support from early-stage R&D strategy and regulatory pathway planning to clinical trial execution and post-market surveillance. Since its establishment in 2015, the company has participated in over 170 medical device clinical research projects, collaborated with more than 1,300 research centers, and successfully facilitated the global market entry of over 30 domestically developed innovative medical devices, including three products that received FDA Breakthrough Device designation.
As a pioneer in the field, CCRC Medtech remains committed to establishing higher standards for clinical research practices. Through its high-quality clinical trial design and execution, the company continues to set benchmarks for the medical device industry. Looking ahead, CCRC Medtech plans to further strengthen its strategic focus on high-risk device areas such as neurointervention and cardiovascular intervention. By building more comprehensive clinical research platforms and integrating global top-tier medical resources, the company aims to accelerate the development and commercialization of innovative medical devices.
The successful approval of MissilEX® represents an important milestone in CCRC Medtech’s development journey and serves as motivation for future endeavors. The company looks forward to collaborating with more partners to jointly advance innovation in China’s medical device industry and bring transformative healthcare technologies to patients worldwide.
