Sep. 23, 2014, 3:45 AM
- Under Treasury Secretary Jack Lew’s crackdown on inversions, the Treasury Department announced new tax rules late yesterday to deter U.S. companies from moving their domicile to countries with lower tax rates.
- The tax changes make it harder for companies to complete overseas mergers, and should they choose to invert, companies will face a hard time using the cash accumulated abroad.
- The new rules are effective immediately and apply to all deals that have not closed by yesterday.
- Related M&A: MDT, COV, SLXP, MYL, CQB, OTC:FYFFF,BKW, THI
Sep. 16, 2014, 2:01 PM
- Results from the 331-patient randomized controlled IN.PACT SFA trial show Medtronic's (MDT +0.3%) IN.PACT Admiral drug-coated balloon (DCB) peripheral artery intervention device outperformed standard percutaneous transluminal angioplasty (PTA) both clinically and economically.
- The 12-month clinically-driven target lesion revascularization (CD-TLR) rate was 2.4% for the IN.PACT Admiral DCB compared to 20.6% for standard PTA. In other words, only 2.4% required another procedure within one year compared to one in five PTA patients.
- In an economic analysis from the U.S. phase of the SFA trial, the follow-up target limb-related medical care costs from discharge to one year were $750/patient lower in the DCB group versus the PTA group, despite higher initial hospital costs. This translates into an incremental cost-effectiveness ratio (ICER) of about $2,900 per repeat revascularization avoided, which is similar to other cardiovascular therapies, including coronary drug-eluting stents.
Sep. 10, 2014, 12:11 PM
- The clinical trial evaluating the safety and efficacy of Medtronic's (MDT +0.7%) CoreValve Evolut R System is underway. The primary efficacy endpoints in the 250-patient prospective study are all-cause mortality and disabling stroke at 30 days and the device success rate at 24 hours to seven days.
- The system consists of the CoreValve Evolut R transcatheter valve and the EnVeo R Delivery System. The self-expanding anatomically designed valve increases conformability at the annulus for optimal fit and sealing while maintaining the supra-annular valve position for improved blood flow and hemodynamic performance. The delivery system offers a reduced catheter profile of 14 Fr equivalent (< 1/5 inch).
- The system offers the option to recapture and reposition the valve during deployment, if necessary, during transcatheter aortic valve replacement.
Aug. 27, 2014, 10:41 AM
- Medtronic (MDT) commences a 3,000-patient 200-site post market clinical trial to assess the superiority of cardiac resynchronization therapy (CRT) devices utilizing the AdaptivCRT feature versus standard CRT in heart failure patients. AdaptivCRT preserves normal heart rhythms and automatically adjusts to patients' needs to customized therapy.
- The primary endpoint is a combination of all-cause mortality and the rate of medical intervention for decompensation (worsening heart failure). Secondary endpoints include the incidence of atrial fibrillation, quality of life measures and cost effectiveness.
- Patients will receive a CRT-pacemaker or CRT-defibrillator equipped with the AdaptivCRT algorithm. They will be randomized 1:1 (aCRT on or off) and will be followed at three and six months after randomization and then every six months until the trial ends.
Aug. 27, 2014, 9:17 AM
- Medtronic (NYSE:MDT) acquires the 70% of privately-held Italian firm NGC Medical S.p.A. that it did not own in a transaction that values the company at $350M. NGC will serve as the Managed Services arm for Medtronic's Hospital Solutions business.
- NGC manages cardiovascular suites, ORs and ICUs at over 30 hospitals in Italy. It is expanding its service offerings across Europe, the Middle East and Africa.
Aug. 26, 2014, 7:11 AM
- Medtronic (NYSE:MDT) acquires privately-held Dutch firm Sapiens Steering Brain Stimulation for ~$200M in cash. The company is developing a deep brain stimulation system with 40 individual stimulation points. It its designed to allow more precise stimulation of the target while reducing the potential for side effects.
- Medtronic will integrate Sapiens into its neuromodulation business.
Aug. 25, 2014, 1:16 PM
- The FDA approves Medtronic's (MDT +0.1%) newest cardiac resynchronization therapy-pacemaker, Viva CRT-P, for patients with heart failure or atrioventricular block. The pacer incorporates the company's proprietary AdaptivCRT alogrithm which preserves normal heart rhythms while automatically adjusting to the patient's needs, creating a customized therapy for each individual.
Aug. 19, 2014, 7:59 AM
- Medtronic (NYSE:MDT) fiscal Q1 results: Revenues: $4,273M (+4.7%); U.S.: $2,333M (+5.8%); International: $1,940M (+3.4%); COGS: $1,105M (+8.1%); Operating Expenses: $2,085M (+9.3%); Net Income: $871M (-8.6%); EPS: $.87 (-6.5%); Quick Assets: $13.96B; CF Ops: $310M (-68.5%).
- Cardiac Rhythm & Heart Failure: $1,256M (+5.3%); Coronary & Structural Heart: $766M (+2.4%); Aortic & Peripheral: $232M (+5.9%); Spine: $743M (-2.9%); Neuromodulation: $479M (+11.9%); Surgical Technologies: $381M (+5.5%); Diabetes Group: $416M (+12.7%).
- Fiscal 2015 Guidance: revenue growth: 3 - 5%; non-GAAP EPS: $4.00 - 4.10.
Aug. 19, 2014, 7:54 AM
Aug. 18, 2014, 5:30 PM
Aug. 1, 2014, 12:54 PM
- The FDA approves Boehringer Ingelheim and Eli Lilly's (LLY -1.3%) Jardiance (empagliflozin) as a treatment for glycemic control in addition to diet and exercise in adults with type 2 diabetes.
- Empagliflozin is a sodium glucose co-transporter 2 inhibitor. It blocks the reabsorption of glucose by the kidney thereby increasing glucose excretion and lowering the level of glucose in the blood.
- Diabetes-related tickers: (MNKD -3.3%) (MRK -0.6%)(SNY +1%)(NVO -2.6%)(GSK -1.4%)(MDT -0.8%)
Aug. 1, 2014, 10:06 AM
- The ENT division of Medtronic's (MDT +0.2%) Surgical Technologies business launches the NuVent EM Sinus Dilation System for the Fusion ENT Navigation System. NuVent is a balloon sinus dilation system with built-in electromagnetic surgical navigation to that helps the surgeon confirm anatomy and optimize the placement of the balloon during sinus surgery.
Jul. 29, 2014, 1:06 PM
- In one of the largest financings this year, privately-held Proteus Digital Health raises $172M. The company is developing a "smart pill" that a patient swallows. It records data on the internal milieu and transmits it externally via a patch on the abdomen. Reactions with stomach juices provide the power.
- One of Proteus' collaborators is Novartis (NVS +0.6%).
- Investors include Novartis, Medtronic (MDT +0.2%), Oracle and Kaiser Permanente.
Jul. 11, 2014, 6:14 PM
- CryoLife (CRY +0.7%) hires James Patrick Mackin as President & CEO effective September 2, 2014 replacing Steven G. Anderson who will transition to the role of Executive Chairman of the Board. Mr. Mackin joins the company from Medtronic (MDT +0.5%) where he was President of Cardiac Disease Management.
- Mr. Mackin's employment contract specifies a base salary of $600,000 per year, a performance-based target bonus of $360,000, two country club memberships, a car allowance of $1,500 per month and up to $30,000 reimbursement for the costs of negotiating his employment contract. In addition, he will receive options to purchase 400,000 shares of CRY stock and a restricted stock grant of 250,000 shares.
Jun. 16, 2014, 9:15 AM
Jun. 16, 2014, 8:18 AM
- Undoubtedly motivated by the looming patent expiration of Lantus, Sanofi (SNY) is teaming up with Medtronic (MDT) on developing drug-device combinations and offering care management services for type 2 diabetes patients. Sanofi brings its insulin portfolio to the partnership while Medtronic brings insulin pumps and glucose monitoring devices. Financial terms are not disclosed.
- Approximately 382M people worldwide have diabetes. Type 2 comprises as much as 95% (363M) of the total.
- The companies already collaborate for Type 1 diabetes in Europe.
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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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