St. Jude Medical (NYSE:STJ) announced Monday that it has won regulatory approval from the European Union to market a smaller implantable cardioverter defibrillator.
The Ellipse is the industry’s smallest high-voltage ICD, said a company news release that described the product as the result of physician input. The device design was arrived at through focus groups of physicians who translated their vision in clay.
“Its thinness, longevity and new discrimination algorithms constitute the answers to the three main concerns of patients and their doctors: decreasing the volume of the can, reducing the risk for infection during ICD replacement and minimizing inappropriate shock,” wrote Dr. L.R.C. Dekker, cardiologist from the Cardiac Center of the Catharina Hospital in Eindhoven, The Netherlands. Dekker implanted the first Ellipse ICD in Europe, according to the company’s statement.
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The Ellipse ICD has the Durata lead that has been under the spotlight ever since St. Jude’s ill-fated Riata and Riata ST leads were pulled from the market because their wires poked through the insulation material. St. Jude has repeatedly defended its Durata leads and has said that it has a proprietary technology that makes it 50 times more resistant to lead abrasion than older models like the Riata.
