Wed, Feb. 18, 1:54 PM
- The FDA's Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meets Friday, February 20 to discuss the Premarket Approval Application (PMA) from privately-held San Clemente, CA-based VertiFlex for its Superion InterSpinous Spacer for the treatment of moderate lumbar stenosis (narrowing of the openings for the spinal cord and nerve roots).
- The device, CE marked in Europe since 2007, alleviates back pain via insertion in the lumbar area which decompresses the spine and relieves the pressure. Its value proposition is a one-piece expandable, reversible and motion preserving implant that is easily inserted via a small incision in the back under local anesthesia in the outpatient setting.
- Executive Summary, Panel Questions
- Related tickers: (NYSE:ABT) (NYSE:MDT) (NYSE:JNJ)
Tue, Feb. 17, 8:13 AM
- Medtronic (NYSE:MDT) fiscal Q3 results ($M): Total Revenues: 4,318 (+3.7%); Cardiac Rhythm & HF: 1,269 (+7.2%), High Power: 650 (-0.8%), Low Power: 489 (+11.4%), AF & Other: 130 (+44.4%); Coronary & Structural Heart: 737 (+2.8%), Coronary: 407 (-6.7%), Structural Heart: 330 (+17.4%); Aortic & Peripheral Vascular: 218 (0.0%); Cardiac & Vascular Group: 2,224 (+5.0%); Spine: 740 (-0.5%), Core Spine: 543 (-2.0%), Interventional Spine: 75 (-2.6%), BMP: 122 (-0.5%); Neuromodulation: 487 (+1.9%); Surgical Technologies: 418 (+8.3%).
- COGS: 1,128 (+7.4%); R&D Expense: 373 (+3.6%); SG&A Expense: 1,487 (+2.3%); Net Income: 977 (+28.2%); EPS: 0.98 (+30.7%); CF Ops: (+9.6%), Quick Assets: 17,231 (+26.1%).
- Gross Profit: 3,190 (+2.5%); COGS: 26.1% (+3.6%); Gross Margin: 73.9% (-1.2%); Operating Earnings: 1,330 (+2.4%); Operating Earnings Yield: 30.8% (-1.3%); Net Earnings Yield: 22.6% (+23.6%).
- CF Ops last three quarters: 310, 913, 1767.
- Fiscal Q4 Guidance: Revenue growth: 4 - 6%.
- Shares are up 3% premarket on increased volume.
Tue, Feb. 17, 7:43 AM
Mon, Feb. 16, 5:30 PM
Wed, Feb. 11, 4:11 PM
Thu, Feb. 5, 9:56 AM
- The FDA approves Medtronic's (MDT +1%) Pipeline Flex embolization device for the treatment of large and giant brain aneurysms. The product is designed to divert blood flow away from the bulging vessel via implantation across the base or neck of the aneurysm.
- The Pipeline Flex is indicated for the endovascular treatment of complex intracranial aneurysms that are not amenable to treatment with surgical clipping and are attached to parent vessels measuring between 2.5 mm and 5.0 mm in diameter. About 500K people worldwide die each year from ruptured brain aneurysms, half younger than age 50.
- The commercial launch will commence in the coming weeks.
Tue, Feb. 3, 1:31 PM
- The FDA approves the Pre-market Approval (PMA) application for Medtronic's (MDT +1.5%) Melody Transcatheter Pulmonary Valve (TPV), which has been available since 2010 under a Humanitarian Device Exemption.
- More than 7,300 people have received the Melody TPV to date, including over 3,700 children. It is placed via a minimally invasive procedure to prolong the time between open-heart surgeries in patients with a dysfunctional right ventricular outflow tract conduit caused by congenital heart disease (CHD).
- CHD is the most common birth defect in the U.S., affecting ~40K babies each year.
Tue, Jan. 27, 8:23 AM
Wed, Jan. 21, 7:40 PM
- Endo International (NASDAQ:ENDP) +2.9% AH on news it will join the S&P 500 later this month, replacing Covidien (NYSE:COV) after its acquisition by Medtronic (NYSE:MDT), which is expected to close next week.
- Also, Boston Beer (NYSE:SAM) will take ENDP’s spot on the S&P MidCap 400, and Southside Bancshares (NASDAQ:SBSI) is tapped to join the S&P SmallCap 600.
Mon, Jan. 12, 12:17 PM| Comment!
Mon, Jan. 5, 9:41 AM| Comment!
Dec. 24, 2014, 12:13 PM
- United Therapeutics (UTHR +2.4%) submits a Pre-Market Approval (PMA) application to the FDA for the use of Medtronic's (MDT +0.7%) SynchroMed II implantable drug infusion system with Remodulin (treprostinil) to deliver the drug intravenously to patients with pulmonary arterial hypertension.
- The company plans to submit a supplemental New Drug Application (sNDA) in January to amend Remodulin's label to include the use of the drug with the device.
Dec. 11, 2014, 10:06 AM
Dec. 2, 2014, 8:03 AM
- Medtronic's (NYSE:MDT) $17B bond offering to help finance its acquisition of Covidien is the year's largest. The tranches are:
- $500M aggregate principal amount (APA) Floating Rate Senior Notes (LIBOR + 0.80%) due March 15, 2020; $1B APA 1.500% Senior Notes due March 15, 2018; $2.5B APA 2.500% Senior Notes due March 15, 2020; $2.5B APA 3.150% Senior Notes due March 15, 2022; $4B APA 3.500% Senior Notes due March 15, 2025; $2.5B APA 4.375% Senior Notes due March 15, 2035 and $4B APA 4.625% Senior Notes due March 15, 2045.
- Closing date is December 10, 2014.
Dec. 2, 2014, 5:09 AM
- With a $17B issuance from Medtronic (NYSE:MDT), U.S. corporate bond sales broke an annual record yesterday, pushing offerings for 2014 past the $1.5T mark.
- The surge in sales has been boosted by record-low borrowing costs, prompting companies to lock in on the low rates.
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Nov. 28, 2014, 10:45 AM
- Medtronic (MDT +1.3%) secures EU approval for its $43B acquisition of Covidien plc (COV +1%) contingent on, as expected, Covidien selling Stellarex, its drug-coated angioplasty balloon. Spectranetics (SPNC +1.9%) agreed to purchase Stellarex several weeks ago for $30M. The FTC recently gave its blessing to the transaction as well.
- Previously: FTC clears Medtronic/Covidien marriage
- Previously: Spectranetics buys Covidien's DCB platform
MDT vs. ETF Alternatives
Medtronic PLC is engaged in providing medical technology alleviating pain, restoring health, and extending life of people. It currently functions in three operating segments that manufacture and sell device-based medical therapies.
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