Updated ClosureFast radiofrequency ablation catheter receives US FDA 510(k) clearance for treatment of CVI


Medtronic has announced that an updated ClosureFast radiofrequency ablation (RFA) catheter in a lower 6Fr profile is now available in the USA following 510(k) clearance from the US Food and Drug Administration (FDA). The ClosureFast procedure is intended to treat chronic venous insufficiency (CVI).

“For patients with mild tortuosity in their saphenous veins, where I would normally use a wire or two access points, I have found that the new ClosureFast 6Fr system glides through more easily than the 7Fr system, providing a better periprocedural experience for the patient,” said Misaki Kiguchi, vascular surgeon at MedStar Heart and Vascular Institute (Washington DC, USA).

With 2.5 million+ patients treated, Medtronic states that the ClosureFast procedure is the global market leader in RFA for the treatment of CVI and has 200+ published clinical studies and articles.

A press release details that ClosureFast 6Fr builds upon the technology’s proven platform. New features in the updated ClosureFast RFA catheter include:

  • A lower profile 6Fr catheter designed for better flexibility, easier navigation, and greater kink resistance, even in tortuous veins
  • Increased length of the heating element (from 7cm to 8cm) for greater procedural efficiency

“Offering the ClosureFast catheter in a lower 6Fr profile is part of our commitment to provide meaningful product advancements for patients,” said David Moeller, SVP and president of Peripheral Vascular Health at Medtronic. “We listened to our customers’ feedback to evolve this trusted, market leading technology. The new features are designed to provide advantages in technical performance and procedural efficiency.”


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