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.
Thu, Jun. 4, 10:49 AM
- St. Jude Medical's (STJ -0.8%) Invisible Trial System is now CE Mark-approved in Europe. The spinal cord stimulation (SCS) system features a small external pulse generator worn on the body that communicates with patient and clinician programming apps accessed via Apple's iPOD touch and iPAD mini.
- SCS devices are use to manage chronic pain. The Invisible Trial System has the capability to deliver both traditional and burst stimulation modes. Burst stimulation minimizes paresthesia, a skin sensation of tingling, burning or itching.
Wed, Jun. 3, 5:46 PM
- St. Jude Medical (NYSE:STJ) resumes its IDE trial assessing its Portico Transcatheter Aortic Valve Implantation (TAVI) system. The study is designed to support the company's regulatory approval application in the U.S. The estimated completion date is August 2019.
- Implantations were suspended in September 2014 due to reports that investigators observed reduced leaflet motion in the implanted valves in certain study participants. The observations were eventually found to be in the control arm, which consisted of commercially available TAVR (transcatheter aortic valve replacement) valves. The company and independent reviewers determined that reduced leaflet mobility is a class effect, present in TAVR and surgical valves across the industry. They found no excess rate of clinical events in patients implanted with Portico specific to leaflet motion. The data also show that reduced leaflet mobility is not linked to excess adverse events, has not been shown to negatively impact the clinical performance of the valves and can be resolved by medical therapy (usually the administration of anticoagulants).
- The Portico system was developed to simplify TAVR procedures for doctors by improving control, ease of use and accuracy compared to other TAVR products. The system also enables the valves to be fully recaptured and repositioned prior to full deployment and release from the delivery system to ensure optimal placement for the best patient outcomes. It was CE Mark-cleared in Europe in late 2012.
Sun, May 10, 6:46 PM
- The FDA approves Nevro's (NYSE:NVRO) Senza spinal cord stimulation system (NYSE:SCS) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain. The Senza system's value proposition is the reduction of pain without paresthesia or tingling sensation, which typically characterizes SCS therapy and that many patients find uncomfortable. Senza avoids paresthesia by delivering high frequency stimulation (10 KHz) and low stimulation amplitudes.
- The FDA also clears Senza for stimulation below 10KHz, which requires paresthesia.
- Related tickers: (NYSE:MDT) (NYSE:BSX) (NYSE:STJ)
Thu, May 7, 5:54 AM
Thu, Apr. 30, 10:10 AM
- The FDA approves St. Jude Medical's (STJ -1.6%) Protege MRI spinal cord stimulation (SCS) system, and MRI compatibility of the 60cm Octrode percutaneous leads for use with the device, for the treatment of chronic pain.
- The Protege MRI is the smallest MR-conditional SCS implantable pulse generator (IPG) available in the U.S. and the only upgradeable IPG that allows patients to safely undergo head and extremity MRI scans.
- SCS therapy uses a small implanted generator to deliver electrical pulses to the spinal column via leads with electrodes. The pulses mask or interrupt pain signals as they travel up the spinal column to the brain thereby reducing the sensation of pain.
Tue, Apr. 28, 1:31 PM
- DaVita Healthcare Partners (DVA -0.2%) upgraded to Outperform with a $95 (14% upside) by Baird.
- St. Jude Medical (STJ +0.5%) upgraded to Outperform with a $84 (15% upside) price target by Credit Suisse.
- Omnicare (OCR -0.3%) downgraded to Sector Perform with a $82 (5% downside risk) price target by RBC Capital and to Neutral by Credit Suisse with a $91 (6% upside) price target.
Wed, Apr. 22, 8:10 AM
- St. Jude Medical (NYSE:STJ) Q1 results ($M): Total Revenues: 1,345 (-1.3%); U.S.: 681 (+5.7%); Intl: 664 (-7.6%); ICD: 411 (-5.7%); Pacemakers: 232 (-7.6%); AF: 270 (+7.6%); Cardiovascular: 324 (-0.6%); Structural Heart: 147 (-4.5%); Vascular: 177 (+2.9%); Neuromodulation: 108 (+9.1%).
- Net Income: 262 (+5.2%); EPS: 0.93 (+8.1%).
- Q2 Guidance: Revenues: $1.370B - 1.395B; GAAP EPS: $0.86 - 0.88; Non-GAAP EPS: $0.99 - 1.01.
- 2015 Guidance: Revenues: $5.440B - 5.515B from $5.45B - 5.55B; GAAP EPS: $3.54 - 3.59 from $3.50 - 3.55; Non-GAAP EPS: $3.92 - 3.97 from $3.95 - 4.00.
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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