Vietnam MOH registration 2403355ĐKLH/BYT-HTTB

Endovascular Stent with a Coating

VN: Khung giá đỡ động mạch có màng bọc

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Medtronic Plc·Registered Nov 06, 2024

Registration details

Analysis ID: 2403355ĐKLH/BYT-HTTB
Submission ID: 17002563/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Medtronic Plc
Manufacturer Country: Theo theo phụ lục
Product Owner: Medtronic Plc
Authorized Representative: CÔNG TY TNHH MEDTRONIC VIỆT NAM

Technical details

Intended Use: The Radiant vascular stent graft is designed to maintain blood flow to the renal arteries when used in combination with the Endurant II/IIs abdominal aortic stent graft. These devices are used together to treat the condition of aneurysm of the common iliac artery or an aneurysm of the abdominal aorta adjacent to the kidney by the technique of parallel grafting, an endovascular procedure. The procedure involves creating a bypass to divert the blood flow in the patient's blood vessels (the abdominal aorta, the common iliac arteries, and the renal arteries) by the method of sac exclusion (the target lesion). Indications: The Radiant vascular stent graft is indicated to maintain blood flow to the renal arteries when used in combination with the Endovascular Support System Endurant II/IIs in the treatment of an aneurysm of the common iliac artery or an aneurysm of the abdominal aorta adjacent to the kidney by the technique of parallel grafting in patients with the following characteristics: • Morphology suitable for the endovascular treatment of the aneurysm • One of the following characteristics: – The diameter of the aneurysm >5 cm – The diameter of the aneurysm from 4 to 5 cm, with an increase of 0.5 cm over the past 6 months – The aneurysm is at least 1.5 times the diameter of the normal renal artery below the kidney • The diameter of the common iliac artery from 19 to 30 mm • The length of the proximal neck below the kidney ≥2 mm and the total length of the covered portion at the proximal neck >15 mm when the Radiant vascular stent graft is deployed in parallel grafting technique in one or both renal arteries and there is minimal calcification or thrombosis with the angle between the suprarenal aorta and the renal artery ≤45°, the infrarenal aorta ≤60°, and the suprarenal aorta ≤45°, and the diameter of the abdominal aorta is less than 20% to 30% smaller than the diameter of the Endovascular Support System Endurant II/IIs as specified in the product label • The approach to the femoral or brachial artery is suitable for the technique, device, or vascular access accessories • Sufficient length of the renal region fixation • The angle of origin of the renal artery <90° relative to the aortic axis Note: The angle between the aortic axis and the renal artery is the angle of origin of the renal artery. An angle <90° is associated with a downward orientation of the renal artery relative to the aortic axis.

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for Endovascular Stent with a Coating in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2403355ĐKLH/BYT-HTTB and manufactured by Medtronic Plc. The authorized representative in Vietnam is CÔNG TY TNHH MEDTRONIC VIỆT NAM.

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