Covidien announced that it has received CE Mark clearance from the European Union for its new self-expanding stent system. In addition to the EverFlex self-expanding peripheral stent, the company also received CE Mark clearance for its Entrust system, which is a cardiovascular delivery device designed to work with the EverFlex stent.
According to an announcement by the company, Covidien plans to commercialize the device in Western Europe starting in February.
The EverFlex stent system has several significant advantages over similar products on the market. Many traditional stent systems require a two-handed insertion procedure. With its Entrust delivery system, surgeons and other healthcare providers can implant the EverFlex stent with a one-handed maneuver. In addition, the Entrust delivery system and the EverFlex stent come in a wide variety of sizes to accommodate a patient’s unique cardiovascular anatomy.
Brian Verrier is the vice president and general manager of Covidien’s peripheral vascular systems division. In prepared remarks, he said, "Our Entrust technology takes 1-handed delivery to a new level for treating patients with varying conditions." He continued, "Like many Covidien innovations, the design of the Entrust delivery system is based on extensive physician feedback and procedural observation."
In March of 2012, Covidien received FDA clearance for its EverFlex stent system. The device has been available in many international countries for the past seven years.