Mon, Mar. 16, 7:44 AM
- Two-year results from the High Risk Study of the CoreValve U.S. pivotal trial show a superior survival benefit in patients receiving Medtronic's (NYSE:MDT) CoreValve via transcatheter aortic valve replacement ((TAVR)) compared to those who underwent surgical aortic valve replacement (SAVR). This is the first study to demonstrate statistically significant survival differences favoring TAVR in aortic stenosis (narrowing of the aorta) patients who are considered high risk for surgery.
- At two years, all-cause mortality in the TAVR cohort was 22.2% compared to 28.6% in the SAVR group (p=0.04). The absolute difference in all-cause mortality between the two cohorts increased from 4.8% at Year One to 6.5% at Year Two.
- The rate of stroke in the TAVR group was 10.9% versus 16.6% in the SAVR group (p=0.05). The major stroke rates were 6.8% and 9.8%, respectively, but the results were not statistically significant (p=0.25). The combined endpoint of all-cause mortality or major stroke favored TAVR (24.2% versus 32.5%, p=0.01).
- Investigator Michael Reardon, M.D., says, "In this trial CoreValve maintains a low and stable stroke rate and the recovery advantages CoreValve demonstrated at one year are maintained at two years. Current ACC/AHA guidelines refer to TAVR as a reasonable alternative to SAVR in high risk patients as judged by the heart team, however these clinical data suggest a change in these guidelines may be warranted for the self-expanding valve in this patient population."
- The data were presented the 64th Annual Scientific Session of the American College of Cardiology.
Thu, Mar. 12, 10:46 AM
- Medtronic (MDT +0.5%) commences a clinical study of its Resolute Onyx drug-eluting stent (DES) in the U.S. in patients with coronary artery disease. The first phase will target patients with small vessels that will require a 2.0 mm stent, which are often untreatable with a DES. Core sizes of the stents will be studied separately.
- Principle investigator Roxana Mehran, M.D., from New York's Mount Sinai School of Medicine says, "One of the biggest challenges we face as interventional cardiologists is treating small, diseased coronary arteries, a common condition seen frequently in patients with diabetes. The initiation of the Resolute Onyx DES with CoreWire Technology is an exciting step forward in providing a treatment option for difficult-to-treat coronary lesions."
- CoreWire Technology builds on the stent manufacturing method called Continuous Sinusoid Technology which molds a single strand of wire into a sinusoidal wave that enables a continuous range of motion. The wire has a denser core surrounded by a cobalt alloy outer layer. This enables the stent to have better visibility during the procedure and, with thinner struts, improved deliverability while maintaining its radial and longitudinal strength.
- The Resolute Onyx DES was CE Mark-cleared in Europe in November. It remains investigational in the U.S.
Tue, Mar. 3, 9:38 AM
- A federal appeals court overturns a $102M jury award to Medtronic (MDT -0.8%) in a long-running patent dispute with NuVasive (NUVA +0.4%) pertaining to spinal implants.
- A jury awarded damages to Medtronic in 2011 after it found that NuVasive's CoRoent XL implants, MaXcess II and III retractors and Helix mini anterior cervical plates violated three Medtronic patents.
- The appeals panel upheld the jury's finding of liability but determined that the damage award was improper because Medtronic is not permitted to recover damages for lost profits or for the sale of conveyed products.
- Medtronic has yet to comment on the situation.
Tue, Feb. 24, 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)
Mon, Feb. 23, 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)
Mon, Feb. 23, 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.
Fri, Feb. 20, 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.
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.
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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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