Wed, Apr. 20, 7:17 AM
Tue, Apr. 19, 5:30 PM
Sun, Apr. 3, 10:52 AM
- St. Jude (NYSE:STJ) is out with another positive study on its CardioMEMS heart failure system this morning:
- "The (Northwell Health) study demonstrated that monitoring pulmonary artery pressure with the CardioMEMS technology leads to significant improvements in quality of life, and ability to exercise (using the six minute walk test standard) in patients with chronic heart failure.
- "The study evaluated 66 patients with Class III heart failure; 34 underwent implant of the CardioMEMS device and 32 patients remained on medical management alone. The study found management with the CardioMEMS device led to a: i) Decrease of nearly seven percent in body weight. ii) Three-fold increase in quality of life scoring. iii) Increase of 38% in the distance patients were able to walk."
- STJ had hoped that its CardioMEMS heart failure system would be adopted by physicians keen on preventing costly readmissions of congestive heart failure patients. However, stymied by coverage rejections from Medicare Administrative Contractors, adoption has been lackluster.
- A recent BMO survey shows that there are other reasons besides reimbursement that are preventing greater adoption: 38% of physicians said they also want to see more clinical data.
- Now read My Top Health Care Equipment & Supplies Stocks For 2016 »
Wed, Mar. 23, 1:13 PM
- The FDA has approved privately held Stimwave, LLC's StimQ Peripheral Nerve Stimulator (PNS) System for the relief of severe intractable chronic pain of peripheral origin. StimQ PNS is a wireless, fully programmable PNS neuromodulation device that can be implanted through a standard needle-size insert or small incision. According to the company, the product's small size minimizes the need for surgery and is much more patient-friendly, avoiding the larger cables and bulky components of other neuromodulators.
- StimQ is less than 5% of the size of other implanted pain relief devices. it is powered by a small fabric patch unit that is worn on the body.
- Pain relief device-related tickers: (STJ -0.1%)(BSX -1%)(MDT -0.2%)(GB +2.9%)(NURO -1.6%)
Fri, Mar. 18, 11:38 AM
- Applied Genetic Technologies (AGTC +0.8%) initiated with Buy rating with $25 (85% upside) price target by Janney Capital.
- Nomura's Ed Ridley has been busy in devices. He rates the following companies a Buy: Boston Scientific (BSX +1%) PT: 22 (22% upside); Zimmer Biomet Holdings (ZBH +0.3%) PT: 123 (18% upside); Edwards Lifesciences (EW +0.8%) PT: 101 (19% upside); St. Jude Medical (STJ +0.5%) PT: 64 (19% upside); Stryker (SYK +0.7%) PT: 115 (6% upside); Medtronic (MDT +0.8%) PT: 86 (13% upside). He rates C.R. Bard (BCR +0.7%) Neutral with a PT of $205 (5% upside).
- Tesaro (TSRO +2.6%) initiated with Buy rating and $65 (46% upside) price target by Citigroup.
- CRH Medical (CRHM +0.1%) initiated with Buy rating and $5 (48% upside) price target by Canaccord Genuity.
- Evoke Pharma (EVOK) initiated with an Outperform rating and $16 (258% upside) price target by Northland Securities.
- NanoString Technologies (NSTG -0.2%) initiated with Buy rating and $21 (31% upside) price target by Janney Capital.
- AbbVie (ABBV +0.6%) initiated with Hold rating and $63 (13% upside) price target by Deutsche Bank.
Fri, Feb. 19, 1:33 PM
Wed, Feb. 17, 4:32 PM
- The Circulatory System Devices Panel of the FDA's Medical Devices Advisory Committee will meet tomorrow to review and make recommendations on clinical trial and postapproval study design and physician training requirements for leadless cardiac pacemakers. The committee will be asked to make recommendations on the acceptability of adverse event rates in acute and chronic time frames, indications for use of the devices, required training and acceptability of observed learning curves and the necessary elements of postapproval studies.
- Executive summary & questions
- Micra panel pack
- Nanostim panel pack
- AHA statement
- Related tickers: (NYSE:MDT)(NYSE:STJ)(NYSE:BSX)
Wed, Feb. 17, 10:31 AM
- The FDA approves St. Jude Medical's (STJ +2.3%) Axium Neurostimulator System for dorsal root ganglion (DRG) stimulation for the treatment of adults with complex regional pain syndrome (CRPS I and II) with moderate-to-severe chronic intractable pain of the lower limbs. Market launch will commence in the coming months.
- Axium was cleared in the EU in November 2011.
Wed, Jan. 27, 8:23 AM
- St. Jude Medical (STJ +0.5%) Q4 results: Revenues: $1,447M (+0.6%); R&D Expense: $177M (+1.1%); SG&A: $588M (+28.7%); Operating Income: $97M (-65.4%); Net Income: $113M (-53.9%); EPS: $0.39 (-53.6%); Non-GAAP EPS: $1.02 (-5.6%).
- FY2015 results: Revenues: $5,541M (-1.4%); R&D Expense: $676M (-2.3%); SG&A: $1,878M (+1.2%); Operating Income: $1,030M (-10.5%); Net Income: $880M (-12.2%); EPS: $3.07 (-11.3%); Non-GAAP EPS: $3.94 (-5.5%); Quick Assets: $667M (-53.7%).
- Q1 Guidance: GAAP EPS: $0.68 - 0.70; Non-GAAP EPS: $0.87 - 0.89.
- 2016 Guidance: Revenues: $5.900B - 6.040B; GAAP EPS: $3.33 - 3.43; Non-GAAP EPS: $3.95 - 4.05.
Wed, Jan. 27, 7:21 AM
- St. Jude Medical (NYSE:STJ): Q4 EPS of $1.02 beats by $0.01.
- Revenue of $1.45B (+0.7% Y/Y) misses by $20M.
Tue, Jan. 26, 5:30 PM
Wed, Jan. 13, 3:59 PM
- With the aim of better aligning its reporting with how it manages its business, St. Jude Medical (STJ -6.6%) reshuffles the components of its five business segments. The changes will be in effect when the company issues Q1 results in late April. Reporting for Q4 and full-year 2015 will remain as is. The newly aligned segments are:
- Heart Failure (HF): bi-ventricular pacemakers and implantable cardioverter-defibrillators (ICDs), ventricular assist devices and the CardioMEMS HF system. 2015 sales: $1.494B.
- Atrial Fibrillation (AF): access, diagnostic, visualization and ablation products plus left atrial appendage closure products. 2015 sales: $1.124B.
- Neuromodulation (NM): neurostimulation products including spinal cord stimulation, dorsal root stimulation, radiofrequency ablation for pain and deep brain stimulation for Parkinson's disease and other neurological disorders. 2015 sales: $475M.
- Cardiovascular Disease (CV): heart valve replacement and repair devices, patent foramen ovale closure devices, structural heart defect devices, active vascular closure devices, compression assist devices, pressure measurement guidewires, diagnostic coronary imaging technology, percutaneous catheter introducers, diagnostic guidewires, percutaneous heart pumps, renal denervation technology and vascular plugs. 2015 sales: $1.211B.
- Traditional Cardiac Rhythm Management (CRM): single and dual chamber pacers, single and dual chamber ICDs. 2015 sales: $1.618B.
Wed, Jan. 13, 8:46 AM
- On a preliminary basis, St. Jude Medical (NYSE:STJ) expects Q4 revenues of $1.447B (+1%). Thoratec products contributed ~$136M. CRM, Atrial Fibrillation, Cardiovascular and Neuromodulation sales were $580M, $276M, $327M and $128M, respectively. Non-GAAP EPS should be $1.01 - 1.02.
- Final results will be released on January 27.
Dec. 10, 2015, 9:43 AM| Dec. 10, 2015, 9:43 AM
Dec. 9, 2015, 10:22 AM
- The FDA approves privately held Stimwave Technologies' Freedom-8A Spinal Cord Stimulation (SCS) System for the treatment of chronic back and leg pain. The fully programmable wireless device features a compact 0.4 cc profile and eight electrodes that are implanted in an outpatient setting through a standard needle without the need for general anesthesia or large surgical incision. Full commercial launch will commence in early 2016.
- Related tickers: (MDT +0.4%)(STJ +0.5%)(BSX -0.4%)(NVRO)
Dec. 7, 2015, 4:47 PM
- St. Jude Medical (NYSE:STJ) declares $0.29/share quarterly dividend, in line with previous.
- Forward yield 1.88%
- Payable Jan. 29; for shareholders of record Dec. 31; ex-div Dec. 29.
St. Jude Medical, Inc. develops, manufactures and distributes cardiovascular medical devices for the global cardiac rhythm management, cardiovascular and atrial fibrillation therapy areas and neurostimulation medical devices for the management of chronic pain. It operates through two operating... More
Industry: Medical Appliances & Equipment
Country: United States
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