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Feb. 23, 2015, 11:04 AM
- The FDA's Orthopedic and Rehabilitation Devices Advisory Panel votes 5 -1 (2 abstain) that VertiFlex's Superion Interspinous Spacer System is safe and 4 -2 (2 abstain) that the risk-benefit profile is adequate.
- The FDA does not have to abide by the vote in its final decision, but it usually follows the committee's recommendation.
- Related tickers: (ABT -0.2%)(MDT +0.3%)(JNJ +0.2%)
- Previously: Ad Comm review approaches for Vertiflex spinal implant (Feb. 18)
Feb. 23, 2015, 9:38 AM
- Medtronic (MDT +0.2%) acquires privately-held Elizabethton, TN-based Advanced Uro-Solutions for an undisclosed sum. The company's lead product is the NURO percutaneous tibial nerve stimulation system for the treatment of overactive bladder (OAB). The 510(k)-cleared device consists of a small external stimulator and a single, reusable lead that provides temporary stimulation to the tibial nerve. Medtronic plans to launch the system in the U.S. in the next 12 months.
- OAB affects ~17% of women and 16% of men in the U.S.
Feb. 20, 2015, 1:00 PM
- The FDA approves Covidien's (MDT +0.1%) VenaSeal system for the permanent treatment of patients with varicose veins of the legs. The device works as follows: a trained clinician inserts a catheter through the skin into the diseased superficial vein. The VenaSeal adhesive, a clear liquid, is then injected through the catheter into the vein where it polymerizes into solid material, permanently sealing the vein.
- VenaSeal's value proposition is the avoidance of heat or cutting, which is more traumatic to tissue. It is performed via an in-office procedure that minimizes bruising and enables patients to quickly return to their normal activities.
- The device was developed by Morrisville, NC-based Sapheon, which Covidien acquired in August of last year.
Feb. 18, 2015, 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)
Feb. 17, 2015, 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.
Feb. 17, 2015, 7:43 AM
- Medtronic (NYSE:MDT): FQ3 EPS of $1.01 beats by $0.04.
- Revenue of $4.32B (+3.8% Y/Y) beats by $70M.
- Shares +0.12% PM.
Feb. 16, 2015, 5:30 PM
Feb. 11, 2015, 4:11 PM
Feb. 5, 2015, 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.
Feb. 3, 2015, 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.
Jan. 27, 2015, 8:23 AM
Jan. 22, 2015, 8:38 AM
- Covidien (COV) FQ1 results: Revenues: $2,686M (+1.8%), Advanced Surgical: $928M (+8.8%), General Surgical: $385M (-5.6%), Surgical Solutions: $1,313M (+4.1%), Vascular Therapies: $428M (+0.7%), Respiratory and Patient Care: $945M (-0.8%); COGS: $1,042M (-3.2%); R&D Expense: $133M (+6.4%); SG&A: $865M (+1.8%); Operating Income: $648M (+22.0%); Net Income: $511M (+28.4%); EPS: $1.12 (+28.7%).
- No guidance given.
Jan. 22, 2015, 8:02 AM
- Covidien (NYSE:COV): FQ1 EPS of $1.11 beats by $0.06.
- Revenue of $2.69B (+1.9% Y/Y) misses by $30M.
Jan. 21, 2015, 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.
Jan. 21, 2015, 5:30 PM
Jan. 12, 2015, 12:17 PM
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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