The US Food and Drug Administration has granted approval to Abbott’s next-generation XIENCE Sierra everolimus-eluting coronary stent system.
The new device expands the company’s existing portfolio of XIENCE stents and comes with improved capabilities to treat complex blockages, including cases with several or completely blocked vessels.
XIENCE Sierra features a thinner profile and improved flexibility with longer lengths and small diameters. The stent obtained the European CE-Mark in October 2017 and Japan’s regulatory approval last month.
Abbott vascular business senior vice-president Chuck Brynelsen said: “We developed XIENCE Sierra so that physicians can more easily deliver the stent even in challenging cases.
“The updated design and improved deliverability mean doctors can access and unblock difficult-to-treat lesions with more flexibility and precision than other stents.”
The company has also reported positive data from the initial 100 subjects in a clinical study being conducted to evaluate its Tendyne Transcatheter Mitral Valve Replacement (TMVR) system.
This transcatheter mitral replacement device has been designed to facilitate repositioning and complete retrieval to enable more precise implantation and subsequently improve patient outcomes.
Tendyne does not require open-heart surgery and involves minimally invasive replacement of native mitral valve for reducing symptoms of heart failure.
Results revealed that after 30 days, patients treated with Tendyne achieved significant decrease in mitral regurgitation symptoms and low mortality rates.
The study involves a total of 350 adult symptomatic mitral regurgitation (MR) patients not eligible for open-heart surgery. Its primary endpoints are safety, procedure-related serious adverse events and performance assessment.