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
Wed, Jul. 22, 7:57 AM
- St. Jude Medical (NYSE:STJ) acquires Thoratec (NASDAQ:THOR) for $63.50 per share ($3.4B). The price represents a 10% premium over yesterday's close of $57.58. The deal should be accretive to STJ's revenue and earnings growth in 2016. The transaction is expected to close in Q4.
- The agreement includes a 30-day go-shop period during which THOR can solicit other offers.
Wed, Jul. 22, 7:34 AM
- St. Jude Medical (NYSE:STJ) Q2 results ($M): Total Revenues: 1,410 (+28.5%); ICD: 421 (-8.9%); Pacemakers: 249 (-8.1%); AF: 279 (+8.6%); Cardiovascular: 343 (-2.3%); Structural Heart: 159; Vascular: 184; Neuromodulation: 118 (+10.3%).
- Net Income: 290 (+7.4%); EPS: 1.02 (+9.7%).
- ICD sales growth has decelerated the past five quarters: 2.1%; 1.8%; 1.0%; -3.6%; -5.7%; -8.9%.
- 2015 Guidance: Revenues: $5.435B - 5.575B from $5.440B - 5.515B; Non-GAAP EPS: $3.96 - 4.00 from $3.92 - 3.97.
- Q3 Guidance: Revenues: $1.325B - 1.365B; Non-GAAP EPS: $0.96 - 0.98.
Wed, Jul. 22, 7:08 AM
Tue, Jul. 21, 5:30 PM
Tue, Jul. 21, 12:41 PM
Mon, Jul. 20, 9:49 AM
Thu, Jul. 16, 9:06 AM
- The FDA approves St. Jude Medical's (NYSE:STJ) Invisible Trial System, a fully wireless spinal cord stimulator that utilizes Apple technology in both the patient and physician controllers. The trial system is deployed prior to permanent implantation in order to evaluate the therapy. The new product eliminates the complex controllers and bulky cables that often dissuade patients from employing permanent SCS therapy.
- The Invisible Trial System uses Bluetooth wireless technology and an iPOD device as the controller. Physicians use an iPAD to program the device and evaluate the therapy. The external pulse generator, the system's power source, is small enough to be worn discreetly under the patient's clothing.
- Spinal cord stimulation (SCS) is used to manage chronic pain. An SCS device interrupts pain signals as they travel along nerve fibers to the brain by delivering low levels of electrical energy to the spinal cord via thin wires (leads).
Sun, Jun. 14, 10:41 AM
- The FDA approves St. Jude Medical's (NYSE:STJ) Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson's disease (PD) and essential tremor in patients who have had inadequate responses to medication.
- The device consists of a battery-powered rechargeable electrical pulse generator that is implanted under the skin of the upper chest with lead wires that attach to electrodes placed in the brain. The pulse generator, which can be adjusted, delivers low intensity electrical pulses to target areas in the brain.
- Approximately 1M Americans live with PD while several million are affected with essential tremor.
- Brio is the second neurostimulator cleared for PD and essential tremor. The FDA approved Medtronic's (NYSE:MDT) Activa Deep Brain Stimulation Therapy System in 1997 for the treatment of tremor associated with essential tremor and PD. In 2002, the agency approved a label expansion to include the symptoms of PD.
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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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