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Vascular Solutions Receives 510(k) Clearance for R350 Guidewire

  • New, Enhanced Version Designed With Nitinol Core and Hydrophilic Coating for Superior Flexibility, Kink-Resistance, and Deliverability in Extreme Vessel Tortuosity
  • 350cm-Length Guidewire Designed for Use in Retrograde Interventional Procedures

MINNEAPOLIS, Nov. 24, 2015 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) 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.”

About Vascular Solutions

Vascular Solutions, Inc. is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company’s product line consists of more than 90 products and services that are sold to interventional cardiologists, interventional radiologists, electrophysiologists, and vein specialists through its direct U.S. sales force and international independent distributor network.

The information in this press release contains forward-looking statements about Vascular Solutions that involve risks and uncertainties. Those statements include expectations about the company’s 2016 revenues and adjusted earnings and growth rates in revenues and adjusted earnings. Vascular Solutions’ actual results could differ materially from those anticipated in these forward-looking statements. Important factors that may cause such differences include those discussed in the company Annual Report on Form 10-K for the year ended December 31, 2014 and other recent filings with the Securities and Exchange Commission. The risks and uncertainties include, without limitation, risks associated with the need for adoption of the company’s new products, defense of criminal litigation, exposure to potential shareholder litigation, exposure to intellectual property claims and litigation, significant variability in quarterly results, exposure to possible product liability claims, doing business in international markets, the development of new products by others, the company’s reliance on the development of new products and services, constraints or interruptions in production from key suppliers, breaches or other failures of information technology and communications systems, the availability of third party reimbursement, and actions by government regulatory agencies.

For further information, connect to www.vasc.com.

Vascular Solutions, Inc. Phil Nalbone, VP-Corp. Dev. PNalbone@vasc.com (763) 656-4371

Source:Vascular Solutions, Inc.