Abbott has obtained CE-Mark for the new generation of its everolimus-eluting XIENCE coronary stent system, allowing the sale of the device for patients with heart disease in Europe.
The new design, delivery system and size of the new XIENCE Sierra stent are intended to improve the ability to access and unblock clogged arteries in complicated cases.
XIENCE Sierra features a thinner profile, enhanced flexibility, longer lengths and small-diameters, enabling doctors to use less force during implantation of the stent.
Abbott vascular business senior vice-president Chuck Brynelsen said: “Doctors tell us they need better tools to treat increasingly challenging cases, which involve multiple or totally blocked arteries and complications such as diabetes.
“We designed XIENCE Sierra with the goal of helping more people with coronary artery disease regain their health and return to their daily lives as quickly as possible.”
The efficacy and safety of XIENCE coronary stent is said to be supported by ten years of real-world experience and data from more than 100 clinical trials.
Abbott has already submitted an application to the US Food and Drug Administration (FDA) for the approval of XIENCE Sierra.
Earlier this month, the firm obtained FDA clearance for its Confirm Rx insertable cardiac monitor (ICM) for remote monitoring and detection of cardiac arrhythmias, including irregular heartbeats.
The smartphone-compatible ICM uses wireless Bluetooth technology to transmit data and requires a rapid and minimally invasive procedure for implantation.
Following the download of a related mobile application on the patient’s smartphone, physicians can continuously monitor and record episodes of irregular heartbeats.