Pursuit Vascular said yesterday that it expanded its domestic footprint and plans to apply for entrance to the European market next year.
Maple Grove, Minn.-based Pursuit Vascular, which makes the ClearGuard HD antimicrobial caps for preventing central-line-associated bloodstream infections, said increased demand for the product prompted it to open new facilities in Dallas, Atlanta and Philadelphia.
The company is also looking north of the border, saying it plans to add resources once it wins Health Canada approval, and hopes to hit the market in the European Union during the second half of 2019.
“The company is actively pursuing CE-Mark regulatory approval in Europe, and has filed all necessary applications to begin the process,” according to a press release.
“Due to the exciting clinical study results, we’re seeing rapid uptake of ClearGuard HD caps nationally across a wide range of providers to include outpatient, hospital inpatient, and long-term acute care settings,” president & CEO Doug Killion said in prepared remarks. “In two different clinical trials, ClearGuard HD caps have been proven to reduce CLABSIs by ~70%. This revolutionary technology represents a breakthrough for dialysis patients and their families.”
In May, the FDA expanded the indication for ClearGuard HD to include reduction in the incidence of central-line associated bloodstream infection in hemodialysis patients with central venous catheters.