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MDT

Medtronic

$77.64

(0.00%)

09:10
04/09/18
04/09
09:10
04/09/18
09:10

Medtronic announces renal denervation pivotal trial for hypertension treatment

Medtronic announced U.S. Food and Drug Administration approval to begin an investigational device exemption pivotal trial to evaluate the Symplicity Spyral renal denervation system in patients with high blood pressure. Renal denervation is a minimally invasive procedure intended to regulate the activity of nerves that lead to and from the kidney, which plays an important role in managing blood pressure. The SPYRAL HTN Pivotal Trial is part of the broader SPYRAL HTN Global Clinical Program, a multi-phased clinical study strategy aimed to establish the safety and efficacy of renal denervation to lower blood pressure.The SPYRAL HTN Pivotal Trial is a 1:1 randomized, sham-controlled study to investigate the renal denervation procedure in up to 433 patients at 50 sites in the U.S., Europe, Australia, and Japan. The trial will investigate the blood pressure lowering effect and safety of renal denervation in the absence of medication. The primary efficacy and safety endpoints in the trial are 24-hour blood pressure at three months and incidence of major adverse events through one-month post-randomization. In addition to the results from the SPYRAL HTN-OFF MED trial and the initiation of the SPYRAL HTN Pivotal Trial, new data from the first 80 patients enrolled in the prospective, randomized, sham-controlled SPYRAL HTN-ON MED trial will be presented during the late-breaking clinical trial session at the EuroPCR meeting commencing in May 2018 in Paris, France. This latest phase of the SPYRAL HTN Global Clinical Program will report the initial safety and efficacy of renal denervation six months following the procedure in patients with uncontrolled hypertension despite ongoing drug therapy.

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MDT Medtronic
$77.64

(0.00%)

02/26/18
PIPR
02/26/18
NO CHANGE
Target $60
PIPR
Overweight
Medtronic news incremental negative for Dexcom, says Piper Jaffray
Medtronic (MDT) this morning announced it received a new arm indication for its Guardian Sensor 3 which improves the accuracy of the sensor to an 8.7% MARD, likely leading to a non-adjunctive claim for standalone, Piper Jaffray analyst JP McKim tells investors in a research note. The news is an incremental negative for Dexcom (DXCM) shares as a path to non-adjunctive claim for Medtronic has become much clearer, McKim contends. He expects a stand-alone launch of Guardian Sensor 3 sometime in 2018. The analyst believes Dexcom carries more negative headline risk in the near term, but he expects the company to remain the market leader in continuous glucose monitors. As such, McKim thinks longer term investors should be buying the stock. He keeps an Overweight rating on Dexcom with a $60 price target. The stock in morning trading is down 12c to $56.24.
03/12/18
WBLR
03/12/18
NO CHANGE
WBLR
Outperform
Insulet announced coverage win with UnitedHealth, says William Blair
Insulet (PODD) on Friday announced it had established a new contract with UnitedHealthcare (UNH), which would provide its patients with in-network, durable medical equipment coverage for Omnipod beginning April 1, William Blair analyst Margaret Kaczor tells investors in a research note. This is another coverage win for Insulet as UnitedHealth represents almost 50M lives in the United States, the analyst adds. She notes Insulet has had limited access to historically a Medtronic (MDT) has been UnitedHealth's preferred, in-network DME insulin pump provider since mid-2016. Kaczor views the announcement as "another improvement in patient access to Omnipod." She thinks Insulet "continues to fire on all cylinders" and keeps an Outperform rating on the shares.
03/12/18
PIPR
03/12/18
NO CHANGE
PIPR
Overweight
Medtronic FDA news a 'nice win' for Dexcom in near-term, says Piper Jaffray
Piper Jaffray analyst JP McKim noted that Medtronic's (MDT) Guardian Connect system received FDA approval, but did not receive a non-adjunctive claim, which Dexcom (DXCM) and Abbott's (ABT) Libre have. The Guardian Connect system will not get Medicare coverage because of this, said McKim, who called the news a "nice win" for Dexcom in the near-term. While Kim does see Medtronic's system getting the claim eventually, he does not expect the Guardian Sensor to be a material threat to Dexcom in 2018 on a standalone basis, calling Medtronic a "pump first company." He keeps an Overweight rating on Dexcom shares.
03/16/18
NEED
03/16/18
DOWNGRADE
NEED
Underperform
Mazor Robotics downgraded to Underperform from Hold at Needham
Needham analyst Mike Matson downgraded Mazor Robotics (MZOR) to Underperform from Hold, forecasting a "significant" slowdown in the company's growth this year as well as more intense competition in the robotics space. Matson adds that Mazor's valuation is priced to a "best case scenario" that is unlikely to be achieved while an acquisition by Medtronic (MDT) is also "extremely unlikely".

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XLU

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