That’s because CSS products amounted to less than $10 million in sales last year, about 2% of the $510.5 million total. The only devices made at the Draper, Utah facility related to Edwards’ flagship Sapien transcatheter aortic valve implant are "delivery system components and accessories," according to a press release.
EW shares were up 0.5% to $64.53 today as of about 12:30 p.m.
"We are committed to thoroughly addressing the issues identified with the quality systems for our CSS devices, and have already initiated responses to address FDA’s observations," chairman & CEO Michael Mussallem said in prepared remarks. "Our first priority is delivering quality, life-saving devices to patients."
Edwards said it doesn’t expect the warning letter to affect its 2013 guidance.
The warning for Edwards could signal a trend for the medical device industry, according to Leerink Swann analyst Danielle Antalffy, as the federal watchdog agency’s Center for Devices & Radiological Health steps up its oversight of medtech.
"We believe today’s announcement is in line with a trend that we think is building in the FDA in regard to issuing Warning Letters and believe their frequency across the industry will continue to increase over the near term," Antalffy wrote last night in a note to investors. "We don’t expect today’s warning letter to have any material impact on the transcatheter heart valve line or on any upcoming product approvals, namely Sapien XT in mid-2014. And importantly, we don’t view today’s warning letter as indicative of systemic problems in EW’s broader manufacturing processes."