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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.
Nov. 10, 2014, 4:47 PM
Nov. 10, 2014, 10:49 AM
- The Japanese Ministry of Health, Labour and Welfare approves Medtronic's (MDT +0.1%) Evera SureScan implantable cardioverter-defibrillator (ICD) for magnetic resonance imaging (MRI) scans positioned on any region of the body. The commercial launch is underway.
- Evera MRI is available in both single chamber and dual chamber ICDs.
- Until the availability of MR-Conditional ICDs, patients with the devices had been contraindicated from receiving MRI scans because of the potential interactions between the MRI and device function.
- Evera MRI is not yet approved in the U.S.
- Related tickers: (STJ +0.7%)(BSX +1.6%)
Oct. 27, 2014, 11:41 AM
- The FDA approves St. Jude Medical's (STJ -0.3%) TactiCath Quartz irrigated ablation catheter. The product gives physicians a real-time objective measure of the force that the catheter applies to a patient's heart wall during an ablation procedure. The technology is associated with a reduction in the rate of atrial fibrillation recurrence when optimal treatment measures are used.
- Related tickers: (BCR +1.2%)(MDT -0.1%)(JNJ +0.9%)(BSX +0.8%)(HNSN +2.1%)(ABT -0.6%)
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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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