Vascular Solutions today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for the Fluent inflation device for use during cardiovascular procedures to create, maintain, and monitor pressure in balloon catheters.
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for the Fluent inflation device for use during cardiovascular procedures to create, maintain, and monitor pressure in balloon catheters. Fluent received CE Mark clearance in August 2016 and has already begun international clinical evaluations. Vascular Solutions expects to commence the commercial launch of Fluent in the U.S. and Europe during the fourth quarter.
“Every angioplasty procedure requires the use of an inflation device, and we are pleased that today’s FDA clearance to market Fluent will allow us to expand our presence in this large, yet competitive, market,” said Howard Root, Chief Executive Officer of Vascular Solutions. “The internally-developed and manufactured Fluent has design and performance characteristics that we believe will make it a popular choice for physicians who perform a wide range of interventional procedures, particularly when combined with Vascular Solutions’ widely-used Guardian hemostasis valves in a convenient interventional pack configuration.”
The Fluent inflation device features a 25cc barrel and creates pressures up to 30 atmospheres of mercury (atm). The ergonomic design provides a system that is easy to fill, flush, and operate. The locking mechanism is marked to show locked and unlocked positions. The pressure gauge glows in the dark so that it is easily readable under low light conditions in the cath lab.
Vascular Solutions will offer the Fluent inflation device in 10 configurations to meet a wide variety of procedural requirements: packaged separately and as a kit including the Guardian hemostasis valve and other angioplasty accessories.
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 has launched more than 100 products 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 that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements. Important factors that may cause such differences include those discussed in our Annual Report on Form 10-K for the year ended December 31, 2015 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 our new products, lack of sustained profitability, exposure to intellectual property claims, significant variability in quarterly results, exposure to possible product liability claims, the development of new products by others, doing business in international markets, the availability of third party reimbursement, and actions by the FDA.
For further information, connect to www.vasc.com.
Contact: Phil Nalbone, VP Vascular Solutions, Inc. firstname.lastname@example.org (763) 656-4371