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Jun. 14, 2015, 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.
Jun. 4, 2015, 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.
Jun. 3, 2015, 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.
May 10, 2015, 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)
May 7, 2015, 5:54 AM
- St. Jude Medical (NYSE:STJ) declares $0.29/share quarterly dividend, in line with previous.
- Forward yield 1.63%
- Payable July 31; for shareholders of record June 30; ex-div June 26.
Apr. 30, 2015, 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.
Apr. 28, 2015, 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 $91 (6% upside) price target.
Apr. 22, 2015, 8:10 AM
- St. Jude Medical (NYSE:STJ) Q1 results ($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.
Apr. 22, 2015, 7:17 AM
- St. Jude Medical (NYSE:STJ): Q1 EPS of $0.93 beats by $0.02.
- Revenue of $1.35B (-0.7% Y/Y) beats by $30M.
Apr. 21, 2015, 5:30 PM
Apr. 20, 2015, 1:07 PM
- St. Jude Medical (STJ +0.8%) exercises its option to acquire Menlo Park, CA-based Spinal Modulation for $175M plus additional payments based on FDA clearance of the Axium Neurostimulator System and the achievement of certain revenue targets.
- The company has had a relationship with Spinal Modulation since January 2013, when it secured exclusive rights to distribute Axium in ex-U.S. territories. It also made a $40M equity investment in the intraspinal neuromodulation therapy firm.
- St. Jude expects to complete the transaction this quarter.
Feb. 24, 2015, 9:43 AM
- The FDA grants 510(k) clearance to privately-held Bioness' StimRouter, an implantable neuromodulation device for the treatment of chronic pain of peripheral nerve origin. It is the first implanted device with a specific indication for peripheral nerve stimulation.
- The system consists of an implanted lead , an external pulse transmitter and conductive electrode and a small hand-held wireless control unit.
- Bioness is yet another medical products firm started by serial entrepreneur Al Mann, the force behind Second Sight Medical Products (EYES +21.3%), MannKind (MNKD -1%), Advanced Bionics and MiniMed.
- Neuromodulation-related tickers: (MDT -0.3%)(STJ -1.9%)(BSX)(NURO)
Feb. 20, 2015, 2:48 PM
- St. Jude Medical (NYSE:STJ) declares $0.29/share quarterly dividend, 7.4% increase from prior dividend of $0.27.
- Forward yield 1.71%
- Payable April 30; for shareholders of record March 31; ex-div March 27.
Jan. 28, 2015, 7:57 AM
- St. Jude Medical (NYSE:STJ) Q4 results ($M): Revenues: 1,439 (+1.2%), International: 761 (-2.6%), U.S.: 678 (+5.8%); ICD: 426 (-3.6%); Pacemakers: 259 (-1.5%); AF: 283 (+12.3%); Cardiovascular: 347 (-0.9%); Neuromodulation: 124 (+7.8%).
- COGS: 425 (-1.2%); R&D Expense: 175 (-5.9%); SG&A Expense: 457 (-3.8%); Net Income: 245 (+99.2%); EPS: 0.84 (+100.0%); Quick Assets: 1,442 (+5.0%).
- Gross Profit: 1,014 (+2.2%); COGS: 29.5% (-2.3%); Gross Margin: 70.5% (+1.0%); Operating Earnings: 382 (+15.4%); Operating Earnings Yield: 26.5% (+14.0%); Net Earnings Yield: 17.0% (+96.8%).
- 2015 Guidance: EPS: $3.50 - 3.55; Non-GAAP EPS: $3.95 - 4.00; Revenues: $5.45B - 5.55B.
- Q1 Guidance: EPS: $0.77 - 0.70; Non-GAAP EPS: $0.90 - 0.92; Revenues: $1.305B - 1.320B.
Jan. 28, 2015, 7:17 AM
- St. Jude Medical (NYSE:STJ): Q4 EPS of $1.03 in-line.
- Revenue of $1.44B (+1.4% Y/Y) in-line.
Jan. 27, 2015, 5:32 PM
- The FDA approves St. Jude Medical's (NYSE:STJ) FlexAbility Ablation Catheter for the treatment of cardiac arrhythmias. The product has a flexible tip which enables it to better conform to the cardiac anatomy.
- It received CE Mark approval in Europe last year.
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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