Vascular Solutions Receives 510(k) Clearance for R350 Guidewire

Vascular Solutions, Inc.

today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for a new and enhanced version of the R350 guidewire, an extra-long guidewire designed for use in complex interventional procedures. The company will begin U.S. sales of the device immediately. The new version of the R350 will replace the original R350 guidewire that was launched in 2012 and will now be discontinued. The design of the new version has been enhanced by the use of a nitinol core, which provides superior flexibility and kink-resistance in even the most extreme tortuosity, and a hydrophilic coating on the distal 200cm for excellent deliverability. 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, M.D., FRCPC, an interventional cardiologist at St. Michael's Hospital in Toronto, commented after his use of the R350: "With renewed emphasis on providing complete revascularization in multivessel coronary disease, interventional cardiologists are performing an increasing number of complex procedures including retrograde approaches to occlusive lesions. These challenging cases require sophisticated and specialized devices. Vascular Solutions' extra-long R350 provides a meaningful step forward in the ability to deliver and efficiently externalize a guidewire in retrograde procedures. Compared to its predecessor and competitors, it has excellent flexibility that improves conformability within the heart and coronary arteries. Importantly, it externalized 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 an extra-long (350cm length) 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. "We are excited about the clearance of our new version of the R350, which adds another high-performance device to our collection of specialized tools for interventional physicians who perform complex cases," said Howard Root, CEO of Vascular Solutions. "The R350 guidewire builds on our history in this area that began with the launch of our GuideLiner catheter six years ago and continued with the launch of our Turnpike catheter earlier this year, with more products working through our pipeline."