Kinetic Concepts Inc. said it won 510(k) clearance from the FDA for a new negative-pressure wound therapy device, the V.A.C.Via, saying it plans to have it on the market in early December.
The V.A.C.Via is a portable wound care system featuring a diaphragm pump for faster draw down, longer battery life and a higher leak rate threshold, according to a press release.
“We’ve listened to the feedback from our customers and patients and have taken our original system and enhanced it to better meet their needs. The V.A.C.Via therapy unit is designed to help patients return to their normal lifestyle, while receiving up to 7 days of negative pressure wound therapy in a compact, portable unit,” senior vice president Jim Cunniff said in prepared remarks.
Kinetic Concepts took a revenue hit in the 3rd quarter, reporting a sales decline of about 2.7% during the 3 months ended Sept. 30, to $320.9 million. The San Antonio-based medical device company attributed the slide to Medicare’s competitive bidding program, which expanded earlier this year to include more cities.