A recent FDA report cites serious flaws in St. Jude Medical's oversight of design changes made to its Durata line of devices. Earlier this year, STJ had released a heavily redacted version of the FDA's report, but the recent release of the same report by the FDA shows highlights a pattern of inadequate verification and flawed testing procedures that could renew concerns over the safety of the Durata device. Shares -0.3% AH.
As the appetite for waging war against Obamacare wanes, smaller fixes are starting to come into the limelight, and are becoming increasingly more realistic, as long as every minor issue doesn’t blow up into a full-scale battle. One small fight is now being picked by medical device companies, who are trying to use the debate to get ObamaCare's tax on medical devices repealed, and it appears that some Democrats may support that initiative.
St. Jude Medical (STJ +2%) says its received European approval for its Portico heart valve replacement device. The approval gives STJ access to a burgeoning market for the devices, and the news gives a much-needed lift to the stock after a string of negative headlines in recent months has driven the stock down near 52-week lows. Since October alone, STJ has shaved nearly 17% off its market cap.
Obamacare is set to "take a toll" on medical-equipment companies due to a "stealth tax" on medical devices, says Tom Lydon of ETF Trends. A number of companies in the sector are planning pre-emptive layoffs in anticipation of the tax, including Medtronic (MDT) and St. Jude (STJ). Other companies in the field include [[J&J]], ISRG and BSX. ETFs worth watching include IYH, XLV, IHI and XHE.
St. Jude Medical (STJ +0.2%) says data from its catheter study, presented today at the annual scientific meeting of the American Heart Association, showed that it’s EnligHTN renal denervation system provided a significant reduction in office and ambulatory blood pressure measurements at six months. In addition, those treated with the system began experiencing a reduction in blood pressure reduction after just 30 days.
St. Jude Medical's (STJ) Amplatzer PFO Occluder, a device to close holes in the heart after a stroke, didn't definitively perform better than drugs in preventing a second stroke in patients aged below 60, two long-term studies have found. The device has been used for almost 20 years, generating under $100M a year; its use could now be called into question.
St. Jude Medical (STJ -6%) could receive a warning letter from the FDA about its manufacturing facility in Sylmar, California, where it produces defibrillators and pacemakers and which the FDA is inspecting. The news, which CEO Dan Starks disclosed on an earnings call, is not a surprise given the massive insulation problems St. Jude has had with the wires for its defibrillators.
More on St. Jude Medical (STJ) Q3: net profit drops to $176M from $227M, due to charges of $80M that are mostly related to restructuring. Outlook: Q4 EPS of $0.86-$0.88 vs. consensus of $0.89. FY EPS of $3.42-$3.44 vs. consensus of $3.43 and prior guidance of $3.40-$3.45. Board authorizes $300M repurchase program. Shares -3.6%.
St. Jude Medical (STJ) only sent a warning to doctors in December 2010 about insulation problems with the wires used with its Riata defibrillators, at least five years after the company first encountered the flaws and two years after an internal audit had specifically identified the issue, the WSJ reports. Riata was withdrawn in 2011.
St. Jude Medical (STJ +1%) says it's published positive results in an online journal from its first large-scale study of peripheral nerve stimulation of the occipital nerves in patients suffering from chronic migraine. The study, which was conducted at 15 U.S. medical centers, demonstrated a significant reduction in pain, headache days and migraine-related disability in patients who, on average, suffered from headache about 21 days per month, and received peripheral nerve stimulation therapy.
Wells Fargo ups St. Jude Medical (STJ +0.4%) to Outperform on valuation this morning, saying the government's investigations into off-label use of implantable cardioverter-defibrillators - like St. Jude's Riata and Durata devices - are nearly done. The investigation caused an 12% drop in the overall U.S. ICD market in 2011, which makes up a big chunk of STJ's total sales. Despite safety concerns about the devices, however, Wells says the company has maintained its market share.
mitrado+ FollowFollowing- Unfollow|Send Message19 Jan 2012
: $MRK over 37.5 is quite a suicidal choice... it can go up to 50, but it can as easily fall back to 30... :-/
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St. Jude Medical, Inc., develops, manufactures and distributes cardiovascular medical devices for global cardiac rhythm management, cardiovascular, atrial fibrillation therapy areas and neurostimulation medical devices for the management of chronic pain.