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
Nov. 26, 2014, 3:57 PM
- The Federal Trade Commission approves the merger between Medtronic (MDT +1%) and Covidien plc (COV +1.2%) with the proviso that Covidien divest its drug-coated catheter business before completing the transaction. Covidien agreed to sell the business for $30M to Spectranetics (SPNC +1%) several weeks ago.
- Previously: Medtronic buying Covidien for $42.9B
Nov. 18, 2014, 8:07 AM
- Medtronic (NYSE:MDT) fiscal Q2 results ($M): Revenues: 4,366 (+4.1%); COGS: 1,142 (+4.8%); Operating Expenses: 1,881 (+3.9%); Net Income: 828 (-7.2%); EPS: 0.83 (-6.7%); CF Ops (6 mo.): 1,223 (-39.4%).
- Revenue by group ($M): Cardiac Rhythm & Heart Failure: 1,320 (+3.7%); Coronary & Structural Heart: 743 (+4.9%); Aortic & Peripheral Vascular: 223 (+2.3%); Spine: 746 (unch); Neuromodulation: 494 (+3.1%); Surgical Technologies: 410 (+8.8%); Restorative Therapies: 1,650 (+3.0%); Diabetes Group: 430 (+9.4%).
- 2015 Guidance: Revenue growth: 4 - 5% from 3 - 5%; non-GAAP EPS: $4.00 - 4.10 (unch).
- Previously: Medtronic EPS and revenue in-line
Nov. 18, 2014, 7:43 AM
Nov. 17, 2014, 5:30 PM
Nov. 17, 2014, 8:24 AM
- At American Heart Association meeting in Chicago, Medtronic (NYSE:MDT) presented new data supporting the clinical and economic value of its cardiac resynchronization therapy (CRT) devices for the treatment of heart failure (HF).
- Over 1M HF patients are hospitalized each year. 25% of them are re-admitted within 30 days and 50% are re-admitted within six months. The mortality rate is ~30%.
- In an effort to determine whether CRT reduces the rate of all-cause readmission within 30 days of a heart failure hospitalization, a meta-analysis of pooled data from five randomized trials involving 3,872 patients was completed. In the group of 678 patients with an index heart failure hospitalization, there was a 26% relative reduction in hospital readmissions in patients treated with CRT. The benefit was higher, 31%, in patients with more advance heart failure (Class III/IV) than Class II at 10%.
- Separately, researchers found that patients who improved or remained unchanged six months after CRT were projected to live longer and consumed fewer hospital resources than patients who worsened.
Nov. 12, 2014, 4:53 AM
- Medtronic (NYSE:MDT) submitted concessions last Friday in a bid to secure regulatory approval for its $43B acquisition of Covidien (NYSE:COV), says the European Commission.
- The EU antitrust authority will decide by Nov. 28 whether to clear the deal.
- A takeover of its Irish rival would reduce Medtronic's overall global tax burden, although it has said that the takeover is not an "inversion" deal for tax reasons.
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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