The FDA has approved Abbott’s next-generation Xience Prime drug eluting stent to treat patients with complex coronary artery disease.

The Xience Prime Everolimus Eluting Coronary Stent System is based on the company’s cobalt-chromium stent technology and is designed to enhance deliverability, flexibility, and more accurate stent placement in patients with symptomatic heart disease due to de novo native coronary artery lesions.

The approval was based on results from the SPIRIT PRIME clinical trial, a prospective, multi-centre, open-label trial involving 500 patients with coronary artery disease at more than 60 centres in the US and Australia. Clinical results show that the trial met its primary endpoint of low rates of target lesion failure (TLF) at one year.

Dr Marco Costa, principal investigator of the SPIRIT PRIME trial, said: “Drug-eluting stent technology continues to advance, leading to improved outcomes for patients with coronary artery disease.”

He said that the medical device “will improve our ability to access challenging, complex lesions, and thereby improve care for our patients”.

Robert Hance, Senior Vice President at Abbott Vascular, said that the FDA’s approval “expands the range of treatment options that we can offer physicians for the benefit of their patients with coronary artery disease”.

Xience Prime received CE Mark Approval in 2009.

Abbott recently split into two companies, one concentrating on research-based pharmaceuticals and the other (Abbott) on medical products.

The FDA has approved Abbott’s stent system for the treatment of renal artery disease in patients with high blood pressure.

RX Herculink Elite is the first stent using cobalt chromium technology to gain a renal indication in the US.

Cobalt chromium allows for thin stent struts, which provides flexibility while maintaining strength to support the vessel and improves visibility during stent implantations enabling more accurate placement.

Michael R. Jaff, Medical Director of the Vascular Center and VasCore, at the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston, said: “This result supports renal stenting as an important treatment option, as elevations in blood pressure can increase heart disease and stroke risk in patients with renal artery stenosis”.

The approval was based on Abbott’s HERCULES (Herculink Elite Cobalt Chromium Renal Stent Trial to Demonstrate Efficacy and Safety) study.

The study involved 202 patients with renal artery stenosis at 37 sites in the US, and demonstrated that the stent is safe and effective, with a significantly low restenosis (vessel re-narrowing) rate of 10.5% at nine months post-treatment.

HERCULES is a prospective study designed to evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in patients with atherosclerotic renal artery stenosis with uncontrolled hypertension.