Vascular Solutions has received 510(k) clearance from the FDA for the Fluent inflation device for use during cardiovascular procedures to create, maintain, and monitor pressure in balloon catheters. A press release reports that the company received CE mark clearance for the device in August 2016 and that Fluent has already begun international clinical evaluations. It adds that Vascular Solutions expects to commence the commercial launch of Fluent in the USA and Europe during the fourth quarter.
The Fluent inflation device features a 25cc barrel and creates pressures up to 30 atmospheres of mercury (atm). According to the press release, 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 haemostasis valve and other angioplasty accessories.
Howard Root, chief executive officer of Vascular Solutions, comments: “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. 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 haemostasis valves in a convenient interventional pack configuration.”