CE Mark For Covidien’s EverFlex Stent With Entrust Delivery System

In short

Covidien has gained CE Mark approval for its EverFlex™ Self-expanding Peripheral Stent with Entrust™ Delivery System.

The advanced stent delivery system, specifically engineered for optimal control, is designed to allow physicians to consistently place stents in the desired location with accuracy and ease. The product will be rolled out in Western Europe next month.


An alternative to the traditional two-handed approach, the Entrust delivery system is currently the only one-handed delivery system on the market with a triaxial design to offer a 5 F profile that is compatible with a 0.035″ guidewire. This unique combination of features is designed for superior performance during stent delivery, even when treating patients with complex conditions. Other features include a diverse range of catheter lengths and a broad stent matrix for greater treatment options.

With the Entrust delivery system, physicians can deploy all sizes of the Covidien EverFlex stent on a low 5 F profile without reducing the stent’s radial force. The EverFlex stent was shown to be safe and effective in the DURABILITY II clinical study.

Physician comments

“This delivery system exceeds my expectations and addresses a true need in the market for better control and accuracy,” said Dr. Arne Schwindt, Senior Vascular Surgeon, St. Franziskus Hospital, Munster, Germany. “With a lower profile, the puncture site is smaller, resulting in less bleeding and other access complications, reduced need for a closure device and faster ambulatory rates. The new 150cm catheter length also allows access to lesions via the brachial artery, which is becoming increasingly necessary for patients with conditions that prevent femoral access.”

Company comments

“Our Entrust technology takes one-handed delivery to a new level for treating patients with varying conditions,” said Brian Verrier, Vice President and General Manager, Peripheral Vascular, Covidien. “Like many Covidien innovations, the design of the Entrust delivery system is based on extensive physician feedback and procedural observation.”

The EverFlex Self-expanding Peripheral Stent with Entrust Delivery System is being demonstrated LINC 2013 (The Leipzig Interventional Course) through January 26.

Source: Covidien, Business Wire