St. Jude Medical (NYSE:STJ) won European regulatory approval for 2 next-generation defibrillators, the Ellipse and the SJM Assura high voltage systems. The new devices aim to bolster device reliability by preventing lead-to-can abrasion, according to the company.
The Ellipse and SJM Assura feature a low-friction coating that aims to reduce insulation abrasion that can occur when the device can rubs against the leads and cause lead-to-can abrasion, the most common type of lead insulation failure, St. Jude reported.
"The goal for this innovative portfolio of devices is to bring implantable defibrillation reliability and patient safety to the next level," said St. Jude president Eric Fain in prepared remarks. "The new Ellipse ICD and Assura family of devices demonstrates St. Jude Medical’s commitment to developing technologies that provide physicians with advanced patient management tools to mitigate the most common ICD lead complications, especially those that can lead to ineffective high voltage therapy delivery."
The low-friction coating improves upon the higher-risk silicon-only insulated defibrillation leads, of which there are still 400,000 in use worldwide, according to a company statement. The shift is an important distinction for St. Jude, which is still in the midst of a high-profile recall of its silicone-insulated Riata and Riata ST defibrillator leads.
The U.S. Justice Dept. recently closed a “civil investigative demand” into the recalled Riata leads, but the company is still a target for litigation. Just last month the medical device maker was slapped with multiple lawsuits in California courts over the Riata defibrillator lead, alleging that the heart wires were defective and led to injuries or death for more than 30 patients.
St. Jude has been attempting to shield its newer Durata leads from the high-profile recall since the company was forced to concede that the Riata revision rates were higher than previously reported. Late last week the Minnesota medtech giant touted positive safety and reliability data on the Durata leads, generated by an independent analysis of Durata registries.
The St. Paul-based medical device company also recently won CE Mark approval in the European Union for the 1st-of-its-kind Allure Quadra quadripolar CRT pacemaker. St. Jude posted profits in the 1st quarter despite a slip in sales, and last month the company was slapped with several personal injury lawsuits for its constant headache, the Riata lead.