Shanghai-based medical device giant MicroPort Scientific Corp., (HKG: 0853) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its FireFalcon coronary spinous process balloon, a novel device designed to enhance vascular dilation in coronary intervention therapy.
Challenges of Traditional Balloon Dilation Techniques
Balloon dilation technique is a common method for achieving vascular dilation in coronary interventions. However, traditional balloons can lead to uneven stress on the blood vessel wall, potentially causing plaque compression, tearing, and dissection. These risks are particularly pronounced when dealing with calcification or fibrosis lesions, and can result in elastic shrinkage post-dilation.
Innovative Design of the FireFalcon Spinous Process Balloon
The FireFalcon coronary spinous process balloon builds upon the foundation of a regular balloon catheter by incorporating nylon cutting elements with triangular-shaped protrusions fixed at both ends of the balloon. Upon inflation, the balloon focuses pressure through these nylon cutting elements, which protrude from the surface of the balloon and transmit force to the inner wall of the blood vessel. This focused pressure allows for the cutting of the intima and the dilation of the narrowed blood vessel, effectively addressing the challenges posed by traditional balloons and reducing the risk of irregular tearing and dissection.
Implications for Coronary Intervention Therapies
The approval of the FireFalcon balloon by the NMPA marks a significant advancement in the field of coronary intervention therapies. Its innovative design offers a more effective and safer approach to vascular dilation, particularly in complex cases involving calcification or fibrosis.-Fineline Info & Tech
