27th January 2021, LifeTech Scientific Corporation (the “Company”) obtained formal written notice from the National Medical Products Administration (“NMPA”) confirming the admission of Artery Stent Graft System (chimney technology) (the “Device”) into the NMPA Special Examination and Approval Procedure for Innovative Medical Services (药监局创新医疗器械特别审查程序) (the “Procedure”). The Device is the world’s first stent graft system especially designed for the “chimney technology”, which is a mainstream technology widely accepted by doctors to treat aortic dissection lesion involving the aortic arch. The Device is the 13th product of the Company having obtained admission to the Procedure.
The Procedure is an important supportive measure for NMPA to encourage and promote the development of innovative medical devices in China, and it could effectively optimize the registration process and facilitate the commercialization for the innovative medical devices domestically.
Research Background
Thoracic aortic dissection is a severe cardiovascular disease, and the primary treatment for the disease is Thoracic Endovascular Aortic Repair (TEVAR).
Due to the special anatomy of aortic arch, it is usually very difficult to perform TEVAR to treat the aortic dissection lesion involving the aortic arch. According to the academic paper [1], around 2/3 of the aortic dissection lesions will involve the aortic arch.
Currently, the “chimney technology” and “fenestration technology” are widely applied in the TEVAR, however, the potential risks, such as endoleak and device migration brings a great challenge in the clinical practice.
Artery Stent Graft System (chimney technology)
The Device possesses independent intellectual property rights and numbers of international patents. The Device consists of the AnkuraTM Pro Artery Stent Graft System (“Ankura™ Pro”) and Longuette™ Aortic Branch Stent Graft System (“Skirt Stent”). Ankura ™ Pro has ability to resist swelling and offers a variety of tapers, making it appropriate for patients with acute and subacute aortic dissections. The Skirt Stent adopts a segmented design concept. The proximal end of the segmented stent provides a large radial support force. When used with the Ankura™ Pro, it can maintain a shape to facilitate smooth blood flow in the branch blood vessels. The distal end of the segmented stent has higher compliance and smaller radial support force which can adapt to various distorted branch blood vessels of various anatomical shapes.
The clinical trial of the Device is on-going in China, and the patient enrollment has been completed in 25 hospitals. The immediate success rate of the procedure was 100%. Currently, the Device is in the follow-up study. Primary result shows that all enrolled patients have been observed patency blood flow after implantation of the Device, while there is no severe device-related adverse event.
LiveCase showed in international endovascular treatment congresses
Artery Stent Graft System (chimney technology) is a key product for Lifetech Scientific to complete its endovascular solution for aortic diseases. The admission of the Procedure will facilitate the market approval process for the Device in China and further consolidate the Company’s competiveness in the market.
Reference
[1]《中华现代外科学杂志》，杜昕，2008-12-27