Medtronic Receives CE Mark for First Balloon Expandable Stent Graft Indicated for ChEVAR

The Radiant Balloon Expandable Stent Graft

Medtronic announced that it recently received CE Mark for its Radiant balloon-expandable stent-graft, the first and currently only stent-graft indicated for use in endovascular chimney aneurysm repair (ChEVAR) with the ChEVAR graft system. Endurant II/IIs stent.

Used together, the Endurant II/IIs stent graft and the Radiant stent graft provide a standardized, fully compliant, ready-to-use solution for short-necked juxtarenal abdominal aortic aneurysms (AAAs). This allows for safe and effective endovascular repair in urgent and elective cases of juxtarenal AAA.

The Radiant product design provides predictable and precise delivery and deployment, while providing the flexibility and radial strength needed for a chimney-covered stent.

The stent graft 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 seal areas.

With this CE mark, Medtronic will deploy a comprehensive education program and continue to invest in clinical data to optimize ChEVAR outcomes for physicians and the patients they treat.

“Having a stent specifically approved for ChEVAR is an important step towards standardizing the technique and materials used. In combination with the strict preoperative protocol regarding planning and sizing, ChEVAR will stabilize its role and approach in existing endovascular alternatives to treat aneurysms with inadequate infrarenal sealing areas,” said Konstantinos Donas, Head of Department. of Vascular Surgery and Director of Vascular Research. Center, Asklepios Clinic Langen, University of Frankfurt (Frankfurt, Germany) said about the Radiant stent.

In partnership with Getinge

The Radiant product is the result of a long-term collaboration between Medtronic and Getinge, leveraging Getinge’s proven Advanta V12 design and eight sizes from the Getinge (Atrium Medical) stent line. It will be produced by Getinge and distributed by Medtronic.

“To support this business expansion, Getinge has invested in doubling its stent manufacturing capacity to provide all of our global customers with the devices needed to treat patients,” said Patty Burns, Senior Director of Global Marketing and company product management, Vascular Systems. , said of the partnership.