PerMedos’s Branched Intraoperative Aortic Stent System – A New Era for Stanford Type A Dissection Treatment Obtained NMPA Approval
The National Medical Products Administration (NMPA) of China approved the launch of the innovative product, the Helix Branched Intraoperative Aortic Stent System from PerMedos on November 28, 2025. This product is primarily intended for the surgical open treatment of Stanford Type A aortic dissection. Its core working principle or mechanism is the first of its kind in China , representing a fundamental improvement in performance or safety compared to similar products and holding a leading technical position internationally.
Core Innovations and Technical Features
The system consists of two main parts: the stent and the delivery system , ingeniously designed to reconstruct the blood flow channel in the aortic arch.
- Stent Component: Integrated Branched Design
- The main body is a self-expanding Nitinol alloy stent covered with an anti-seepage membrane made of Polytetrafluoroethylene (PTFE).
- The key innovation is the integration of artificial blood vessels (made of PET, collagen, and glycerin) , which are used during the operation to reconstruct the branched vessels leading to the head and arm (such as the left common carotid artery and left subclavian artery).
- Flexible and Adjustable Branch Spacing: The spacing of the branched vessels can be adjusted intraoperatively within a range of 4mm to 12mm and can be acutely curved (>90°). This adaptability accommodates the anatomical differences in the aortic arch among patients, improving conformability and blood flow patency.
- Special Waveform Design: Features a self-expanding structure with large wave peaks on the greater curve side and small wave peaks on the lesser curve side, perfectly adapting to the physiological curvature of the aortic arch. It also provides real-time visualization of the isolation effect and intraoperative closure of the dissection.
- Excellent biocompatibility due to the integrated PET/collagen artificial blood vessels.
- Delivery System Component: Controllable Segmental Release
- Composed of components like the large catheter, small catheter, and the release knob.
- By rotating the release knob, the surgeon can segmentally and precisely release the stent. This controllable release method helps to enhance the safety and accuracy of the operation.
- Marker lines assist in X-ray positioning.
Significant Clinical Advantages
PerMedos aims to provide a more effective surgical option for the treatment of the fatal Type A aortic dissection, significantly improving patient outcomes.
- Reduced Operative Time:
- The total operation time is shortened by 1 to 2 hours.
- The time required for anastomosis of the left subclavian/left common carotid artery is reduced to less than 30 minutes per side.
- Segmental release technology theoretically reduces cardiopulmonary bypass (CPB) time by 20-30% , resulting in CPB time of less than 120 minutes.
- Lower Complication Risks:
- Reduced CPB time lessens the inflammatory response and organ damage.
- Low complication risk with a reported endoleak rate of <5% and branch patency rate of >95%.
- Improved Surgical Precision:
- The design, featuring a special waveform and adjustable spacing, ensures the stent conforms better to the patient’s physiological structure.
This product offers surgeons a more efficient and anatomically conforming surgical solution for treating Type A aortic dissection, which is of great importance for improving the success rate of this high-risk procedure and the prognosis of patients.