Consiz™ Atrial Septal Sizing Balloon Catheter by Wuyou Tiaodong Receives NMPA Approval as Breakthrough Class III Medical Device
Recently,ConSiz, independently developed by Wuyou Tiaodong Medical Technology (Shenzhen) Co., Ltd.™The Atrial Septal Measurement Balloon Catheter Has Officially Received the Class III Medical Device Registration Certificate from the National Medical Products Administration (Registration No. Guo Xie Zhu Zhun 20243032084).This innovative product is primarily used to measure defects in the atrial septum, specifically for patients whose correct selection of occluder size depends on precise defect measurement.
Atrial septal defect (ASD) and patent foramen ovale (PFO) are the two most common congenital heart diseases, both involving abnormalities of the atrial septum that can lead to abnormal blood flow between the atria. With the rapid development of interventional therapy techniques for congenital heart disease, China has made significant progress in this field, establishing a mature treatment system that provides patients with more accessible medical services and substantial clinical benefits. In interventional therapy, the size of the atrial septal defect is a key anatomical parameter; it not only guides the selection of occluder devices but also directly influences postoperative outcomes.Balloon catheter sizing of the defect is widely regarded as the industry “gold standard,” offering an intuitive and precise approach that ensures accurate measurement of atrial septal defects.
Breakthrough 0.0001''-Class ConSiz™Ultra-Soft, Ultra-Thin Atrial Septum Measurement Ultra-Compliant Balloon: The Company’s Second Major Product Launch in Its Integrated PFO Diagnosis and Treatment Portfolio, specifically designed for accurate measurement of atrial septal defect dimensions, particularly for large atrial septal defects, those with soft rims, long and narrow tunnels, and irregular morphologies, assisting operators in accurately selecting the appropriate occluder size in clinical practice.Additionally, ConSiz™Atrial Septal Measurement Balloon Catheter: Through upgrades and improvements to the balloon material, it not only possesses superior deformability but also maintains ultra-low dilation force even under extreme deformation, effectively preventing injury to the measured site.
Wuyou Tiaodong ConSiz™Ultra-soft and ultra-thin atrial septal measurement of ultra-compliant balloons has the following product features:
Special balloon material with high elasticity and flexibility, offering several times the deformability of conventional ultra-compliant balloons. It maintains ultra-low dilation pressure even under extreme deformation, effectively preventing damage and tearing to the target site.
This product is available in four models, each optimized for specific clinical scenarios to ensure appropriate balloon length and prevent slippage from the target site. Furthermore, with a balloon diameter range of 3–44 mm, it effectively addresses various types of defects, meeting the needs of diverse patients.
Ultra-thin-walled balloons with a wall thickness of 0.0001 inches are available with 6F, 7F, and 8F shafts, ensuring an extremely small outer diameter for passage. This design not only optimizes device deliverability but also reduces vascular injury, enhancing procedural safety.
The unique radiopaque marker design, combined with shaft radiopacity, enables precise balloon positioning to ensure the accuracy and reliability of the measurement process.
Utilizing 0.035" catheter technology combined with state-of-the-art bevel tip design, this innovation breaks away from conventional structures to ensure smoother maneuverability during every procedure, thereby enhancing the user experience.
The balloon features exceptional burst pressure resistance and durable fatigue endurance, undergoing rigorous testing standards to ensure safety during use.
Company Profile
Wuyou Tiaodong Medical Technology (Shenzhen) Co., Ltd., established in 2021, is a national high-tech enterprise specializing in interventional therapies for heart diseases, particularly structural heart diseases. Its current product portfolio primarily focuses on patent foramen ovale (PFO), with the goal of providing comprehensive diagnostic and therapeutic solutions for PFO. Adhering to the core values of “innovation, collaboration, diligence, and mutual benefit,” and upholding the noble mission of “maximizing patients’ quality of life and strengthening the final barrier safeguarding life,” the company is committed to delivering innovative medical device solutions to patients and aspires to become a leader in innovative medical devices within the cardiology field within ten years.
ConSuper™ Occluder Delivery System(NMPA Registration No. 20243030961)
ConSiz™ Atrial Septal Measurement Balloon Catheter(National Medical Device Registration No. 20243032084)
Hot Investment Opportunities Available!
Mr. Guo: 18007176716(WeChat ID same as phone number)
Mr. Xie: 18025491443 (WeChat ID same as phone number)