St. Jude Medical Inc. has won the U.S. Food and Drug Administration (:FDA) approval for its Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The devices received CE Mark approval in May 2013.
The advanced devices from the company’s Cardiac Rhythm Management business incorporate unique features that are capable of delivering high-voltage treatment to patients with heart failure. St. Jude is a pioneer in providing a low-friction coating on the ICD device instead of the lead, that helps lower the risk of lead-to-can abrasion.
Wake the dead, tell them, had they only survived the shorting, they could have tried this new and improved lead. We tested this one, the left leaning FDA made us this time.
A new day for St. Jude:
Ernest Lau, a cardiologist at the Royal Victoria Hospital in Ireland, was one of the first doctors to identify a defect in Riata that led to its recall in 2011. Now Lau is telling colleagues it’s time to embrace the company’s updated device.
Riata, a wire that connects a life-saving defibrillator to the heart, could break out of its protective coating, putting patients at risk for inappropriate shocks or leaving them untreated when a shock was needed. Lau noted the flaw in 2006, and subsequent tests to patients found the problem occurred in 15 percent. St. Jude pulled the device from the market in 2010, with U.S. regulators calling it a recall the next year.
Shorts better cover now that lead issue has been put to rest. Wouldn't be surprised to see $50's and with the lead cloud fading fast, someone like JNJ or Abbott swoop in and buy St. Jude.
Sentiment: Strong Buy
Durata Leads (June 25, 2013)
Less than two weeks ago, an anonymous physician report to the FDA indicating that the product failed in a single patient sent the company's stock into a tailspin. Like a CSI investigator, the company tracked down the lead in question and determined it was damaged due to external abrasion--by scraping against something within the body. To St. Jude's likely relief, that's very different than the "inside-out abrasion" that damaged Riata leads and drove the company to pull the leads from the market in 2010, and the FDA to issue a Class I recall last December.