Covidien's EverFlex Self-Expanding Peripheral Stent With Entrust Delivery System Gains CE Mark Approval

January 23, 2013—Covidien (Mansfield, MA) announced CE Mark approval for its EverFlex self-expanding peripheral stent with Entrust delivery system. The company announced the European regulatory approval and introduced the device at LINC 2013:  Leipzig Interventional Course in Leipzig, Germany. The device will be commercially launched in Western Europe in February.

According to the company's press release, the Entrust delivery system offers an alternative to the traditional two-handed approach. The device is a one-handed delivery system with a triaxial design and a 5-F profile that is compatible with a 0.035-inch guidewire. This combination of features is designed for superior performance during stent delivery, even when treating patients with complex conditions. Other features include a range of catheter lengths and a broad stent matrix for greater treatment options. The stent delivery system is engineered for optimal control, allowing physicians to consistently place stents in the desired location with accuracy and ease, stated Covidien.

Covidien advised that with the Entrust delivery system, all sizes of the Covidien EverFlex stent can be deployed 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.

In Covidien's press release, Arne Schwindt, MD, Senior Vascular Surgeon at St. Franziskus Hospital in Munster, Germany, commented, “This delivery system exceeds my expectations and addresses a true need in the market for better control and accuracy. 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 150-cm catheter length also allows access to lesions via the brachial artery, which is becoming increasingly necessary for patients with conditions that prevent femoral access.”