Abbott (NYSE:ABT) said today that it won FDA approval for its Xience Sierra everolimus-eluting coronary stent.
The company’s device features a thin profile, improved flexibility and longer lengths than previous stents. The device and delivery system were designed to help clinicians tackle complex cases, like those involving multiple or totally blocked vessels, according to Abbott.
“We developed XIENCE Sierra so that physicians can more easily deliver the stent even in challenging cases,” Chuck Brynelsen, SVP of Abbott’s vascular unit, said in prepared remarks. “The updated design and improved deliverability mean doctors can access and unblock difficult-to-treat lesions with more flexibility and precision than other stents.”
Abbott won CE Mark clearance for Xience Sierra in October last year and regulatory approval in Japan earlier this year. The device has been used in more than 8 million people worldwide, Abbott touted.
Last year, the company touted results from a quality-of-life analysis based on data from its Xience Excel study, which enrolled 1,905 people to compare the safety and efficacy of percutaneous coronary intervention with Abbott’s Xience coronary stent and coronary artery bypass grafting in patients with left main coronary artery disease.
After one month, one year and three years, patients were asked to report the frequency of things like angina and symptoms of depression.
Patients who were treated with Xience reported significantly greater freedom from angina and 60% of them said they had no difficulty breathing compared to 44% of people who had surgery.
Also last year, reports surfaced revealing that Abbott will not introduce its Xience Sierra stent to the Indian market due to measures that cap the prices for metal, drug-eluting and bioresorbable stents.
