Oct. 1, 2014, 10:05 AM
- In response to the ever-increasing risk of security breaches, the FDA issues final guidance for device makers entitled, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." The agency recommends that device manufacturers consider cybersecurity risks at part of the design and development of their products and submit documentation to the FDA about the risks identified and the controls in place to mitigate them. The agency also recommends that companies submit their plans for patches and upgrades to device operating systems and medical software.
- The agency will hold a public workshop on October 21, 2014 to discuss how all the constituency groups can work together to improve cybersecurity in medical devices and protect the public health.
- ETFs: IBB, BIB, IRY, IXJ, BIS, DRGS
- Some related tickers: (MDT -0.2%)(BSX -0.9%)(STJ -0.3%)(ABT -0.6%)(JNJ -1.4%)(OTCQX:RHHBY +0.1%)
Oct. 1, 2014, 8:21 AM
- Yesterday, the U.S. Government released the first comprehensive disclosure of payments made by medical companies to doctors. Over the first five months of 2013, med firms paid $3.5B to doctors to fund items such as research, consulting, royalties to hospitals to help develop products and fees for speaking engagements. The monies were disbursed in two broad categories: research funding and fees to doctors for consulting and other non-research services.
- Roche's (OTCQX:RHHBY) Genentech unit led the way in the non-research category with $135M. Most of this (90%) went to a Southern California hospital network for royalties.
- Bristol-Myers Squibb (NYSE:BMY) was #1 in the research category with $329M which, according to the company, was largely the value of experimental medicines used in studies.
- Medtronic (NYSE:MDT) paid one unidentified doctor ~$3M who was among a group of six physicians paid at least $500K by the device maker. The company's total outlay for the period was $30.1M.
- Johnson & Johnson (NYSE:JNJ) paid $68M for non-research expenses.
- The disclosures, mandated by Obamacare, cover 4.4M payments to ~550K doctors and 1,360 teaching hospitals from August to December 2013.
- The disclosures are a bit controversial. Physicians complained that the government did not give them enough time to review the data to correct mistakes.
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
Sep. 25, 2014, 9:05 AM| Sep. 25, 2014, 9:05 AM | Comment!
Sep. 23, 2014, 7:45 AM
- U.S. Treasury Secretary Jack Lew says that the Obama Administration is prepared to institute rules to stop tax inversion deals. If so, it will do so without a sliver of Republican support. Barclays analyst Michael Leuchten says, "Washington is playing for time. It makes them look good and it allows Congress to maybe get its act together and maybe do something on the legislative side."
- Mr. Lew's comments have spooked the market a bit. European companies already involved in deals or rumored to be targets are all under pressure due to the perception that some of the deals already announced may be at risk.
- The U.S. firm in the best position is Horizon Pharma (NASDAQ:HZNP). It completed its tax inversion transaction with Ireland-based Vidara Therapeutics last week.
- Related tickers: (MDT -0.4%)(COV -0.5%)(ABBV -0.6%)(SHPG -0.7%)(OTCQB:SHPGF -1.5%)(PFE -0.7%)(AZN -0.1%)(SNN +0.1%)(SYK -0.8%)
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. 17, 2014, 4:17 PM
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. 28, 2014, 7:23 AM| Aug. 28, 2014, 7:23 AM | Comment!
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, 2:09 PM
- The FDA approves Covidien's (COV -0.7%) change in its process of making the polytetrafluoroethylene coating on the delivery wire of the firm's Pipeline embolization device. Covidien recalled certain lots of the Pipeline and Alligator retrieval devices on April 1, 2014 after determining that the lead wire could delaminate and detach from the devices.
- The company expects only a slight negative effect on Q4 results considering the timely resolution of the problem.
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. 22, 2014, 7:18 AM
Aug. 20, 2014, 4:22 PM
- Covidien (COV +0.4%) debuts its Covidien Center of Innovation (CCI) Brazil. The Sao Paulo-based 3,000 square meter facility will serve as a hub for training health care professionals on the latest medical technology. It has the capacity to offer 120 courses and educate up to 2,000 clinicians per year.
- It contains a surgical lab equipped for minimally invasive surgeries using electronic and computer simulators in addition to silicone models, a clinical scenario simulation lab equipped with a human patient simulator, a lab for educating in medical and hospital procedures, an Anatomage touchscreen table (study the human body's anatomy in a virtual patient), an R&D lab and a 160-person auditorium.
- The company also has CCI facilities in China, South Korea, India and Turkey.
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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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