The European Union has granted CE mark to Covidien's EverFlex self-expanding peripheral stent for use with Entrust delivery system.
Entrust system, which the company claims to be the only one-handed delivery device on the market, features a triaxial design to offer a 5 F profile that is compatible with a 0.035" guidewire and broad stent matrix for greater treatment options.
The system also features various catheter lengths including 150cm length, which allows access to lesions not via femoral artery, but via the brachial artery, claims the company.
The company also said the lower profile delivery system can be used by clinicians for deploying all sizes of EverFlex stent ranging from (20 mm – 200 mm) on a low 5 F profile without reducing the stent’s radial force.
During the company’s DURABILITY II clinical study, the EverFlex stent has demonstrated its safety, efficacy and a proven stent patency rate at one year.
In addition, Entrust offers clinical advantages of making small puncture at the site during stent deployment, which results in less bleeding and faster ambulatory rates.
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,"