Vascular Solutions’ R350 guidewire receives 510(k) clearance


An enhanced version of Vascular Solutions’ R350 extra-long guidewire has been granted US Food and Drug Administration (FDA) 510(k) clearance, according to a press release.

The original R350 guidewire, which was launched in 2012, will be discontinued and replaced by the enhanced version. The new R350 uses a nitinol core, designed to provide superior flexibility and kink-resistance in extreme tortuosity, and a hydrophilic coating on the distal 200cm.

Initial clinical evaluations of the new version of the R350 guidewire were performed in Canada, where Vascular Solutions received regulatory clearance earlier in 2015. Christopher Buller, an interventional cardiologist at St. Michael’s Hospital, Toronto, comments, “Compared to its predecessor and competitors, it has excellent flexibility that improves conformability within the heart and coronary arteries. Importantly, it externalised more easily than any wire I had previously used. I expect this characteristic will save procedural time, avoid certain procedural failure modes, and potentially reduce patient and staff radiation exposure.”

The Vascular Solutions’ R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature. The R350 guidewire is a 350cm guidewire for use with 0.014” lumen catheters. It is designed for use in procedures that are performed with a retrograde (against blood flow) approach to the targeted lesion.