Medtronic announced that it has recently received CE mark for its Radiant balloon-expandable covered stent, the first and currently, only, covered stent indicated for use in chimney endovascular aneurysm repair (ChEVAR) with the Endurant II/IIs stent graft system.
Used together, the Endurant II/IIs stent graft and Radiant covered stent offer a standardised, fully on-label, off-the-shelf solution for short-neck, juxtarenal abdominal aortic aneurysms (AAA). This enables safe and effective endovascular repair in both urgent and elective juxtarenal AAA cases.
The Radiant product’s design offers predictable, accurate delivery and deployment, while providing the flexibility and radial strength necessary for a chimney covered stent.
The covered stent is intended to maintain perfusion to the renal arteries when used in combination with the Endurant II/IIs stent graft system for AAA patients with inadequate sealing zones.
With this CE mark, Medtronic will roll out a comprehensive training programme and continue to invest in clinical data to optimise ChEVAR outcomes for physicians and the patients they treat.
“Having a stent graft specifically approved for ChEVAR reflects a milestone towards standardisation of the technique and the materials used. In combination with the strict preoperative protocol regarding planning and sizing, ChEVAR will stabilise its role and approach in the existing endovascular alternatives to treat aneurysms with inadequate infrarenal sealing zones,” Konstantinos Donas, head of the Department of Vascular Surgery and director of the Research Vascular Centre, Asklepios Clinic Langen, University of Frankfurt (Frankfurt, Germany) said of the Radiant stent graft.
In partnership with Getinge
The Radiant product comes from the long-term collaboration between Medtronic and Getinge, leveraging Getinge’s proven Advanta V12 design and eight sizes of the Getinge (Atrium Medical) stent portfolio. It will be produced by Getinge and distributed by Medtronic.
“To support this business expansion, Getinge has invested in doubling our stent production capacity in order to provide all of our global customers with the devices needed to treat patients,” the company’s senior director of Global Marketing and Product Management, Vascular Systems, Patty Burns, said of the partnership.