The US FDA has approved Xience Prime, a next generation everolimus eluting coronary stent system for patients with coronary artery disease. According to Abbot Laboratories, this new stent offers doctors a wider range of drug eluting stents which have emanated from the SPIRIT family of trials. The company says that Xience Prime has an improved stent design and a more flexible delivery system compared to the Xience V® Everolimus Eluting Coronary Stent System. It also offers ideal radial strength and more accurate stent placement. The new stent uses the same drug and biocompatible polymer as the Xience V.
Marco Costa, M.D., Ph.D., principal investigator of the global SPIRIT PRIME trial, said:
“Drug eluting stent technology continues to advance, leading to improved outcomes for patients with coronary artery disease. With XIENCE PRIME, for the first time in the U.S., physicians have a 38 mm everolimus-eluting stent for the treatment of long lesions. The enhanced deliverability and wide range of sizes, including a small-vessel 2.25 mm-diameter stent, will improve our ability to access challenging, complex lesions, and thereby improve care for our patients.”
The US Food and Drug Administration (FDA) says that its approval was based on the results of the SPIRIT PRIME trial, an open-label, prospective trial involving 500 participants with coronary artery disease. It was conducted in over 60 centers in Australia and the USA.
Two registry arms were assessed:
- The Core Size arm – Xience Prime stents were used, measuring 8mm to 28mm long and 2.25mm to 4mm in diameter.
- The Long Lesion arm – Xience Prime stents were used, measuring either 33mm or 38mm long, and 2.5mm and 4mm in diameter.
The clinical trial met its primary endpoint, with low rates of TLF (target lesion failure) at one year (a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization). Rates for stent thrombosis after twelve months were also low.
Abbot Laboratories says the trial results will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco, by Dr. Costa next Tuesday, on November 8th.
Xience Prime received CE mark in Europe in 2009. Today, after the latest FDA approval, it is also available in most parts of Asia, the Middle East and the USA.
According to Abbot Laboratories:
“XIENCE PRIME is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions ≤32 mm) with reference vessel diameters of ≥2.25 mm to ≤4.25 mm.”
Xience Prime Everolimus Eluting Coronary Stent System. According to Abbot it has the following advantages: Thin struts (0.0032″ strut thickness), Low dose of everolimus drug gone at 4 months, Safe and Biocompatible4 coating technology (thin, durable)
Written by Christian Nordqvist