Covidien has announced receiving European approval for the EverFlex Self-expanding Peripheral Stent with Entrust Delivery System. The one hand operated device features tri-axial construction with a 5 F profile catheter that works with 0.035” guidewires. Because of the narrow profile, ease of control, and one handed operation, Covidien promises greater ability for physicians to deliver stents to the right place.
Accordin to the company the stenting system should be available in Western Europe starting next month.
From the announcement:
“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.”
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.