Covidien receives CE mark for EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System


Covidien has announced CE mark approval for its EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System.

According to the company, 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 made available in Western Europe next month.

An alternative to the traditional two-handed approach, the Entrust delivery system allowed one-handed delivery with a triaxial design with a 5 F profile that is compatible with a 0.035” guidewire. The combination of these 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.

“This delivery system exceeds my expectations and addresses a true need in the market for better control and accuracy,” Arne Schwindt, senior vascular Surgeon, Saint 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.”

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.

“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.

The EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System was demonstrated at LINC (The Leipzig Interventional Course) on 26 January 2013.