Medtronic’s Radiant Balloon-Expandable Covered Stent Receives CE Mark for ChEVAR Indication

September 20, 2022—Medtronic announced that it recently received CE Mark approval for the Radiant balloon-expandable covered stent, which is indicated for use in chimney endovascular aneurysm repair (ChEVAR) with the company’s Endurant II/IIs stent graft system.

According to Medtronic, the Radiant system is intended to maintain perfusion to the renal arteries when used in combination with the Endurant II/IIs system for abdominal aortic aneurysms (AAA) patients with inadequate sealing zones.

Used together, the two devices offer a standardized, fully on-label, off-the-shelf solution for short-neck, juxtarenal AAAs in both urgent and elective cases. The Radiant is designed to offer predictable, accurate delivery and deployment, while providing the flexibility and radial strength necessary for a chimney-covered stent, stated Medtronic.

The Radiant device will be commercially available in Western Europe in November 2022. It will be released in other regions that recognize CE Mark in 2023. Medtronic further advised it will initiate a comprehensive training program and continue to invest in clinical data to optimize ChEVAR outcomes.

In related news, Getinge announced a supply partnership with Medtronic for the Radiant covered stent—which is a private-labeled Getinge Advanta V12 balloon expandable covered stent. The device is produced by Getinge and distributed by Medtronic. Getinge will manufacture the Radiant covered stent for Medtronic, starting Q4 2022.

As noted by Medtronic, the Radiant device comes from the long-term collaboration between Medtronic and Getinge, leveraging the proven Advanta V12 design and bringing it to the next level by collecting robust clinical evidence to support the CE Mark in ENCHANT: the Endurant ChEVAR New Indication Trial.

“Having a stent graft specifically approved for ChEVAR reflects a milestone toward standardization of the technique and the materials used,” commented Professor Konstantinos Donas, MD, in Medtronic’s press release. “In combination with the strict preoperative protocol regarding planning and sizing, ChEVAR will stabilize its role and approach in the existing endovascular alternatives to treat aneurysms with inadequate infrarenal sealing zones.” Prof. Donas is Head of the Department of Vascular Surgery, Director of the Research Vascular Center, at Asklepios Clinic Langen and University of Frankfurt in Frankfurt, Germany.