FDA Approves Abbott's Xience Nano and Boston Scientific's Promus to Treat Small Vessel CAD

May 24, 2011—Abbott Vascular (Santa Clara, CA) announced that it has received US Food and Drug Administration (FDA) approval for the Xience Nano coronary everolimus-eluting stent (EES) system for the treatment of coronary artery disease in vessels as small as 2.25 mm in diameter.

The company stated that the Xience Nano features a cobalt chromium stent design, 0.0032-inch struts, and a 2.25-mm diameter to treat small vessels, which are often associated with increased levels of restenosis after stent implantation. The device is based on the same platform as the company's Xience V EES system. The Xience EES product line is now available in 2.25- to 4-mm diameters in the United States. Abbott offers the Xience V in the United States, Europe, Japan, and other international markets.

On May 25, Boston Scientific Corporation (Natick, MA) also announced FDA approval and the immediate United States launch of its 2.25-mm Promus coronary EES system for use in vessels as small as 2.25 mm in diameter. The Promus stent is a private-labeled Xience V coronary EES system manufactured by Abbott and distributed by Boston Scientific.

Boston Scientific stated that the 2.25-mm Promus EES joins the 2.25-mm Ion paclitaxel-eluting platinum chromium stent as the company's approved drug-eluting stenting options for small vessels. Boston Scientific's Promus EES is now available in diameters from 2.25 to 4 mm and lengths from 8 to 28 mm, the company stated.

According to Abbott Vascular, FDA approval of Xience Nano was supported by results from the company's SPIRIT Small Vessel Registry. The SPIRIT Small Vessel results showed very low late loss of 0.2 mm and a target lesion failure rate of 8.1%, which is comparable to results observed in the SPIRIT clinical trials with Xience V. Target lesion failure is defined as cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization.

“The treatment of small vessels is often complex and associated with higher rates of complications compared to larger vessels,” commented Marco Costa, MD, Principal Investigator of Abbott's SPIRIT Small Vessel clinical trial. “I am confident that the highly deliverable Xience Nano stent, with its thin struts and effective everolimus-eluting platform, will help physicians treat their patients who have coronary artery disease in small vessels.”

On behalf of Boston Scientific, Dean J. Kereiakes, MD, stated, “The Promus stent has demonstrated outstanding deliverability, low late loss, and excellent safety in numerous clinical trials and extensive real-world practice. These benefits make the Promus 2.25-mm stent an attractive option for United States physicians treating patients with small vessels.”