Thu, Nov. 19, 9:12 AM
- The FDA approves St. Jude Medical's (NYSE:STJ) Proclaim Elite Spinal Cord Stimulation (SCS) System for the treatment of chronic pain. It is the first upgradeable and recharge-free SCS system cleared in the U.S. The device is also MRI-compatible for head and extremity scans.
- The system features an Apple iPAD mini-based programmer that allows clinicians to program and adjust their patients' SCS therapy. Patients are able to directly assess their therapy with the company's Invisible Trial System, which is a discreet, app-based wireless neuromodulation programming system featured on an Apple iPAD touch mobile device.
Wed, Oct. 21, 8:55 AM
- St. Jude Medical (STJ -0.03%) Q3 results: Revenues: $1,339M (-2.4%), ICD: $392M (-7.1%), Pacemakers: $238M (-10.5%), Atrial Fibrillation: $271M (+7.1%), Cardiovascular: $317M (-2.2%), Neuromodulation: $121M (+13.1%); COGS: $425M (+3.2%); R&D Expense: $161M (-4.7%); SG&A: $413M (-8.8%); Operating Income: $294M (+8.9%); Net Income: $215M (-9.7%); EPS: $0.75 (-8.5%); Quick Assets: $2,535M (+75.8%).
- Q4 Guidance: Revenues: $1.455B - 1.480B; GAAP EPS: $0.35 - 0.41; Non-GAAP EPS: $1.00 - 1.02.
- 2015 Guidance: Revenues: $5.549B - 5.574 from $5.435B - 5.575B; GAAP EPS: $3.04 - 3.10; Non-GAAP EPS: $3.93 - 3.95 from $3.96 - 4.00.
Wed, Oct. 21, 7:18 AM
Tue, Oct. 20, 5:30 PM
Tue, Oct. 20, 10:04 AM
Mon, Oct. 12, 9:01 AM
- St. Jude Medical's (NYSE:STJ) HeartMate 3 Left Ventricular Assist System (LVAS) is now CE Mark-approved in the EU. The device is indicated for cardiac support in patients with advanced heart failure who are waiting for a transplant, are in myocardial recovery or advanced heart failure patients who are not candidates for a transplant.
- HeartMate 3 is the first commercially-approved centrifugal-flow LVAD (left ventricular assist device) that utilizes fully magnetically-levitated technology (Full MagLev). The magnetic forces suspend the device's rotor which reduces the stress to the blood as it passes through the pump.
- The HeartMate 3, designed to supplement the pumping ability of the left ventricle, can pump up to 10 liters of blood per minute. The system includes a centrifugal pump that is implanted directly onto the patient's heart while the device itself is implanted above the diaphragm next to the heart and attached to the aorta. The patient wears an external controller and battery pack that powers the pump.
- St. Jude acquired the rights the HeartMate 3 via its acquisition of Thoratec.
Thu, Oct. 8, 5:52 PM
- St. Jude Medical (NYSE:STJ) closes on its acquisition of Thoratec (NASDAQ:THOR), a deal it struck this summer for $3.4B that will add key products to St. Jude's heart failure portfolio.
- All shares of Thoratec outstanding at the close today have been converted to the right to get $63.50 in cash, and the shares will be delisted from Nasdaq.
- St. Jude expects the deal to be accretive to EPS in 2016. Analyst consensus for 2016 earnings per share is $4.34 on $5.87B in revenues.
Wed, Oct. 7, 4:31 PM
Fri, Oct. 2, 6:14 PM
- St. Jude Medical (STJ +1.7%) says in an SEC filing that it received a warning letter from the FDA regarding non-conformities at the Atlanta facility where it makes the CardioMEMS HF system, an implant to measure pulmonary artery pressure.
- The FDA has issued an early regulatory action based on inspections throughout June, and St. Jude responded regarding corrective actions.
- St. Jude says it continues to provide the FDA with monthly updates on remediating its concerns, and that it will keep manufacturing and shipping product from the Atlanta facility. It believes the FDA's concerns will be addressed without material impact.
- Shares were down 0.6% after hours prior to the filing.
Tue, Sep. 22, 8:17 AM
- St. Jude Medical's (NYSE:STJ) Infinity Deep Brain Stimulation (DBS) System and its directional DBS lead are now CE Mark cleared. The device, which will be offered in two sizes, is the only ungradeable DBS system available to patients fighting movement disorders such as Parkinson's.
- Infinity uses Bluetooth wireless technology to communicate with Apple digital devices which serve as patient and physician controllers.
Fri, Sep. 18, 9:21 AM
- St. Jude Medical (NYSE:STJ) announces CE Mark clearance for the 27mm and 29mm Portico Transcatheter Aortic Valve Replacement (TAVR) System. The approval follows the earlier clearance of the 23mm and 25mm valves. Portico can accommodate a patient's native anatomy with diameters ranging from 19mm to 27mm.
- The Portico system was developed to simplify TAVR procedures for doctors by improving control, ease of use and accuracy. For example, the valves can be fully recaptured and repositioned prior to full deployment to ensure the best fit.
Wed, Sep. 9, 10:08 AM
- St. Jude Medical (STJ -1.4%) announces a leadership transition plan following the retirement of Chairman, President and CEO Dan Starks. Effective January 1, 2016 COO Mike Rousseau will become President and CEO as Mr. Starks transitions to Executive Chairman.
- Mr. Rousseau joined the company in 1999 as Senior Vice President, Cardiac Rhythm Management Global Marketing.
Thu, Aug. 27, 9:05 AM
- Abbott Laboratories (NYSE:ABT) has denied a report that it's preparing an offer for St. Jude Medical (NYSE:STJ) that would value the medical device maker at about $25B.
- St. Jude shares have now pared back their gains in early trading after surging 17% on the rumor.
- STJ +4.9% premarket
- Previously: FT: Abbott prepping $25B takeover offer for St. Jude (Aug. 27 2015)
Thu, Aug. 27, 7:18 AM
- Abbott Laboratories (NYSE:ABT) is preparing a takeover bid for St. Jude Medical (NYSE:STJ) that is likely to value the medical device maker at $25B, FT reports.
- Sources say the firm has been working with advisers for several weeks, lining up the financing for a cash and stock offer.
- Abbott and St. Jude already have a strong alliance in the field of cardiovascular devices, and a full merger would give the enlarged company greater leverage in negotiating with healthcare providers.
- STJ +13.2% premarket
- Update: Quoting a spokesperson, Bloomberg says Abbott isn't making an offer for St. Jude.
Tue, Aug. 4, 5:44 PM
Thu, Jul. 23, 1:16 PM| Thu, Jul. 23, 1:16 PM | 5 Comments
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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