Nov. 19, 2014, 7:48 AM
- During the scientific sessions at the American Heart Association meeting in Chicago, investigators presented a retrospective data analysis from the CHAMPION clinical trial evaluating the safety and efficacy of St. Jude Medical's (NYSE:STJ) CardioMEMS HF System in patients with New York Heart Association Class III heart failure (HF) who had been hospitalized for HF in the previous 12 months.
- The device is implanted in the pulmonary artery (PA) during a minimally invasive procedure to directly measure PA pressure via a miniaturized wireless monitoring sensor. Measuring PA pressure allows clinicians to proactively manage treatment with medication changes for patients with worsening HF before visible symptoms occur. The system allows patients to transmit PA pressure data from their homes to their doctors enabling them to adjust the meds to reduce the likelihood of hospitalization.
- In patients aged 65 and older, patients implanted with the CardioMEMS HF Systems had 58% fewer all-cause hospital readmissions and 78% fewer HF readmissions compared to standard-of-care medical management. The results suggest that the use of the CardioMEMS HF Systems could reduce a hospital's risk of government-imposed financial penalties from patient readmissions with 30 days of treatment.
Nov. 10, 2014, 10:49 AM
- The Japanese Ministry of Health, Labour and Welfare approves Medtronic's (MDT +0.1%) Evera SureScan implantable cardioverter-defibrillator (ICD) for magnetic resonance imaging (MRI) scans positioned on any region of the body. The commercial launch is underway.
- Evera MRI is available in both single chamber and dual chamber ICDs.
- Until the availability of MR-Conditional ICDs, patients with the devices had been contraindicated from receiving MRI scans because of the potential interactions between the MRI and device function.
- Evera MRI is not yet approved in the U.S.
- Related tickers: (STJ +0.7%)(BSX +1.6%)
Oct. 27, 2014, 11:41 AM
- The FDA approves St. Jude Medical's (STJ -0.3%) TactiCath Quartz irrigated ablation catheter. The product gives physicians a real-time objective measure of the force that the catheter applies to a patient's heart wall during an ablation procedure. The technology is associated with a reduction in the rate of atrial fibrillation recurrence when optimal treatment measures are used.
- Related tickers: (BCR +1.2%)(MDT -0.1%)(JNJ +0.9%)(BSX +0.8%)(HNSN +2.1%)(ABT -0.6%)
Oct. 21, 2014, 5:17 PM
Oct. 15, 2014, 8:30 AM
- St. Jude Medical (NYSE:STJ) Q3 revenue growth by selected line item:
- Leaders: Intl Neuromodulation: +14.3%; International Atrial Fibrillation: +11.5%; WW Atrial Fibrillation: +7.7%; U.S. Cardiovascular: +5.3%.
- Laggards: International ICD: -3.0%; International Cardiac Rhythm Management: -2.2%; International Pacemakers: -1.3%; U.S. Neuromodulation: -1.3%.
Oct. 15, 2014, 8:20 AM
- St. Jude Medical (NYSE:STJ) Q3 results: Revenues: $1,372M (+2.5%); International: $706M (+2.0%); U.S.: $666M (+3.1%); WW Cardiac Rhythm Management (CRM): $688M (-0.3%); International CRM: $315M (-2.2%); U.S. CRM: $373M (+3.6%); WW ICD: $422M (+1.0%); Intl ICD: $160M (-3.0%); U.S. ICD: $262M (+3.6%); WW Pacemakers: $266M (+0.8%); Intl Pacemakers: $155M (-1.3%); U.S. Pacemakers: $111M (+3.7%); WW AF: $253M (+7.7%); Intl AF: $155M (+11.5%); U.S. AF: $98M (+2.1%); WW Cardiovascular: $324M (+2.2%); Intl Cardiovascular: $204M (+0.5%); U.S. Cardiovascular: $120M (+5.3%); WW Neuromodulation: $107M (+2.9%); Intl Neuromodulation: $32M (+14.3%); U.S. Neuromodulation: $75M (-1.3%).
- COGS: $412M (+7.0%); R&D Expense: $169M (-1.7%); SG&A Expense: $476M (+5.3%); Net Income: $238M (-9.2%); EPS: $0.82 (-8.9%); Quick Assets: $1,294M (+3.9%).
- Gross Profit: $960M (+0.7%); COGS: 30.0% (+4.4%); Gross Margin: 70.0% (-1.8%); Operating Profit: $315M (-4.3%); Operating Earnings Yield: 23.0% (-6.6%); Net Earnings Yield: 17.3% (-11.4%).
- 2014 guidance: Revenues: $5.568B - 5.648B from $5.64B - 5.76B; EPS: $3.97 - 3.99 from $3.96 - 4.01.
- Q4 guidance: Revenues: $1.385B - 1.465B; EPS: $1.02 - 1.04.
Oct. 15, 2014, 7:34 AM| Comment!
Oct. 14, 2014, 5:30 PM
Oct. 1, 2014, 6:23 PM
Oct. 1, 2014, 4:37 PM
Oct. 1, 2014, 10:05 AM
- In response to the ever-increasing risk of security breaches, the FDA issues final guidance for device makers entitled, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." The agency recommends that device manufacturers consider cybersecurity risks at part of the design and development of their products and submit documentation to the FDA about the risks identified and the controls in place to mitigate them. The agency also recommends that companies submit their plans for patches and upgrades to device operating systems and medical software.
- The agency will hold a public workshop on October 21, 2014 to discuss how all the constituency groups can work together to improve cybersecurity in medical devices and protect the public health.
- ETFs: IBB, BIB, IRY, IXJ, BIS, DRGS
- Some related tickers: (MDT -0.2%)(BSX -0.9%)(STJ -0.3%)(ABT -0.6%)(JNJ -1.4%)(OTCQX:RHHBY +0.1%)
Sep. 15, 2014, 11:51 AM
- The FDA and EC issue 510(k) and CE Mark clearances, respectively, to St. Jude Medical (STJ -1.1%) for its Optis Integrated System, which is directly installed into a hospital's cardiac catheterization laboratory. It fully integrates optical coherence tomography (OCT) and fractional flow reserve in percutaneous coronary intervention (PCI) workflow.
- It is the first PCI optimization system to offer OCT and angiography co-registration. It supports procedural decisions by providing high-resolution 3D OCT views of coronary anatomy while mapping the exact location of the current view via angiogram.
- It also integrates the company's PressureWire fractional flow reserve measurement technology which provides hemodynamic information during PCI.
Aug. 27, 2014, 12:46 PM| Comment!
Jul. 29, 2014, 6:21 PM
Jul. 22, 2014, 8:53 AM| Comment!
Jul. 16, 2014, 8:21 AM
- St. Jude Medical (NYSE:STJ) Q2 results: Total Revenues: $1,448M (+3.2%); ICD: $462M (+1.8%); Pacemakers: $271M (+2.7%); AF: $257M (+8.4%); Cardiovascular: $351M (+3.2%); Neuromodulation: $107M (-0.9%).
- COGS: $433M (+13.4%); R&D Expense: $178M (+2.9%); SG&A Expense: $523M (+7.0%); Net Income: $270M (+134.8%); EPS: $0.93 (+132.5%); Quick Assets: $1,580M (+29.5%).
- Gross Profit: $1,015M (-0.6%); COGS%: 29.9% (+9.8%); Gross Margin%: 70.1% (-3.7%); Operating Profit: $314M (-12.5%); Operating Earnings Yield: 21.7% (-15.3%); Net Earnings Yield: 18.6% (+127.5%).
- 2014 EPS guidance raised to $3.96 - 4.01 from $3.76 - 3.81 on revenues of $5.64B - 5.76B.
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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.
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