Healthcare products company Covidien has obtained European CE mark approval for its EverFlex self-expanding peripheral stent, to be used with its accompanying Entrust delivery system.
The Entrust system, which the company claims is the only one-handed delivery device currently on the market, features a triaxial design to offer a 5 F profile for better treatment options.
The system also features various catheter lengths including 150cm, which allows access to lesions via the brachial artery, but not via the femoral artery, claims Covidien.
The company also said the lower profile delivery system can be used by clinicians for deploying all sizes of EverFlex stent ranging from (20mm – 200mm) on a low 5 F profile, which is compatible with a 0.035in guidewire and broad stent matrix, without reducing the stent’s radial force.
During the company’s Durability II clinical study, the EverFlex stent demonstrated its safety, efficacy and a proven stent patency rate at one year.
Entrust also offers the clinical advantage of making a small puncture at the site during stent deployment, which results in less bleeding and faster ambulatory rates, according to the company.
St Franziskus Hospital senior vascular surgeon Dr Arne Schwindt said; "This delivery system exceeds my expectations and addresses a true need in the market for better control and accuracy."
Covidien is planning to launch the technology in Western Europe in February 2013.
