U.S. approval for the device, which is smaller and has new capabilities, is expected this year.
St. Jude Medical announced Monday that it has received European market approval of a new, smaller Ellipse implantable cardioverter defibrillator (ICD).
St. Jude said the device, which treats abnormally fast and potentially lethal heart rhythms, was designed with feedback from more than 200 physicians from around the world.
Physician focus groups helped St. Jude develop the Ellipse ICD's unique shape by crafting in clay their ideas for the ideal defibrillator design. St. Jude said the physician-inspired shape "is unlike any currently available, with each of the enhancements designed to increase patient comfort or make the device easier to implant."
The Ellipse includes protection against inappropriate and unnecessary shocks to the heart. It adds new lead-monitoring capabilities and the ability to automatically withhold a shock in the presence of electrical "noise" in the defibrillator's leads, wires that connect the device to the heart.
The new feature is expected to help physicians lower the risk of lead-related complications, according to St. Jude.
Thom Gunderson, an analyst with Piper Jaffray & Co., characterized Ellipse's European approval as "another incremental advancement" for St. Jude. But, he said, it is good news for the company after a rough week.
"It's refreshing to have non-controversial news from St. Jude," he said.
The Little Canada-based medical device manufacturer has been buffeted by a December 2011 recall of its Riata defibrillator lead and a recent study by Minneapolis cardiologist Robert Hauser that linked Riata leads to at least 20 patient deaths.
Last week, St. Jude requested a retraction of a Hauser article from Heart Rhythm Journal and disputed his findings. St. Jude's stock, which fell about 10 percent last week, dropped 33 cents Monday to $38.25.
A spokeswoman for St. Jude said the company expects approval to launch Ellipse in the United States later this year.
James Walsh 612-673-7428