Apr. 22, 2014, 7:22 AM
- In a short 2-1 decision, the U.S. Court of Appeals for the Federal Circuit rules that Medtronic (MDT) may continue selling the CoreValve System until it makes its final decision sometime this summer. The Court did not explain the basis for its ruling but Medtronic argued that implementing the injunction would put patients' lives at risk.
- The company's patent dispute with Edwards Lifesciences (EW) has clinicians scrambling for alternatives because Medtronic offers its device in a larger number of sizes and is appropriate for those patients who do not have the correct anatomy for the Edwards product.
- Edwards '552 patent expired in May 2012 but the USPTO has issued three one-year extensions. A final extension has yet to be issued.
- Medtronic believes the patent rights are limited.
Apr. 19, 2014, 11:17 PM
- With the injunction preventing Medtronic (MDT) from selling its CoreValve System taking effect in just a few days on April 23, the company asks the U.S. Court of Appeals to postpone the order until the firm can determine if the injunction was properly issued. The Court has yet to rule but it did grant its request for an expedited review of its appeal.
- The firm and Edwards Lifesciences (EW) are currently negotiating a mechanism whereby clinicians currently trained on CoreValve can make patient-specific decisions regarding whether to implant Medtronic's device or Edwards' without being constrained by CoreValve's availability. The companies must report their status on the issue to the Court on May 21 although they can implement a plan earlier based on mutual agreement.
- Medtronic believes that Edwards and the Court have inappropriately applied provisions of patent term extension regarding the Anderson '552 patent which expired in May 2012.
Apr. 15, 2014, 6:25 PM
- Surgical device maker ConMed (CNMD) is exploring a sale of the company, Reuters reported earlier today, after activist investors late last year took issue with its performance and corporate governance.
- The company's advisers, BoA Merrill Lynch and Greenhill, reportedly have contacted orthopedic device makers in recent weeks to gauge interest.
- CNMD has an attractive orthopedics and sports medicine business that could appeal to companies such as Zimmer Holdings (ZMH), Johnson & Johnson (JNJ), Stryker (SYK), Covidien (COV) and Medtronic (MDT).
- CNMD shares gained 7.2%, rallying from a loss before the report late in the session.
Apr. 14, 2014, 8:01 AM
- The U.S. District Court in Delaware grants a preliminary injunction limiting the sale of Medtronic's (MDT) CoreValve system in the U.S. The order will go into effect in seven days.
- The court's ruling reaffirms an earlier decision that CoreValve infringes on Edward Lifesciences' (EW) U.S. Anderson patent.
- The judge orders both companies to confer on the specific instances where CoreValve can continue to be used on U.S. patients at medical centers trained on Medtronic's device.
- The litigation began in 2008. In late 2013, the U.S. Supreme Court declined to hear MDT's appeal.
- In a separate case, a federal jury in January found CoreValve infringes in EW's U.S. Cribier patent.
- EW is up 13% premarket while MDT is down ~5%, both on light volume.
Apr. 11, 2014, 8:34 AM
- The FDA approves Medtronics' (MDT) CRT devices to treat patients with atrioventricular (AV) block and left ventricular systolic dysfunction.
- Patients designated as New York Heart Association Class I, II and III with AV block that need a high percentage of ventricular pacing and have an ejection fraction <=50% will now be able to receive biventricular pacing with the company's CRT devices.
- More than 1M Americans suffer from AV block.
Apr. 9, 2014, 4:44 PM
- Some leading U.S. and European cardiologists favor curbs on sales or an outright moratorium on renal denervation devices.
- After Medtronic's (MDT +0.7%) Simplicity clinical trial failed to meet its efficacy endpoint doctors question the continued use of the product to treat high blood pressure in patients who fail to gain enough of a benefit from drugs.
- The therapy is currently approved in more than 80 countries. Analysts believe the U.S. market would be $3B if and when the FDA approves a device for the indication.
- The renal denervation procedure uses a catheter to insert the device through the groin and into the kidney where it applies RF pulses to the renal arteries to damage the nerve endings in the vascular wall. Physicians believe these nerves contribute to elevated blood pressure.
- (BSX) (STJ)
Apr. 8, 2014, 9:57 AM
- Medtronic (MDT) spinal-cord stimulators implanted into the backs of three paraplegic patients helped them wiggle their toes and ankles, flex their legs and even stand independently for moments at a time.
- The treatment worked in two patients who were previously unable to move or feel their lower bodies.
- Researchers now intend to conduct a similar study with eight more patients, using a new device with more flexibility.
Mar. 31, 2014, 4:34 AM
- Edwards Lifesciences' (EW) Sapien XT heart valve, which can be inserted without open-heart surgery, outperformed a rival device from Medtronic (MDT) in a head-to-head comparison of 241 patients.
- Sapien XT led to improved symptoms in patients, less leakage, was easier to insert and had a similar death rate to Medtronic's CoreValve, which, in a separate study, was shown to have better mortality figures than open-heart procedures.
- While a previous version of the Sapien has generated disappointing sales, analysts believe that the market for the devices could eventually be worth $3B a year.
Mar. 30, 2014, 1:36 AM
- Medtronic's (MDT) CoreValve, an aortic valve that doctors can insert into the heart without cracking open ribs, cut death rates more than open-heart surgery in a trial of 747 people.
- In the study, 14% of patients who received CoreValve died within a year of surgery vs 19% of those who had open-heart surgery.
- "This is the type of evidence that changes guidelines and recommendations for care," says Mount Sinai Hospital's David Adams.
- Edwards Lifesciences (EW) sells a similar device but it hasn't proved more effective than open-heart surgery and sales have been lower than expected. (PR)
- Meanwhile, Medtronic plans to continue working on its Symplicity device for reducing blood pressure despite a surprising failure in trials. The company said "signals" in the data suggest that the treatment might benefit certain patients and that the procedure involving the device may not have been carried out correctly or completely during the testing. (PR)
Mar. 10, 2014, 8:41 AM
- Wells Fargo upgrades Edwards Lifesciences (EW) to Outperform with a price target of $82 - $83, up from $67 - $69.
- Catalysts for the upgrade include new transcatheter mitral valve implants that will boost 2016 revenue, an improved outlook for Sapien XT and upside potential from litigation with Medtronic (MDT) due to its infringement of two EW US patents.
- EW closed Friday at $72.07.
Mar. 7, 2014, 12:41 PM
- North Carolina surgeon Stuart Meloy may have discovered a game changer for some women: a device that produces "orgasms on demand". He decided to pursue developing the product after witnessing a female patient's intense stimulation after he placed electrodes in her lower back for an undisclosed condition.
- The device consists of two electrodes that will be surgically inserted into certain nerves in the spinal column and a cigarette pack-size signal generator implanted in the upper buttock. The user presses a remote control button for stimulation.
- The device will be studied for women who have serious cases of orgasmic dysfunction where some women's brains interpret arousal as a fear response.
- Medtronic (MDT) has signed on to conduct tests.
- No decision on developing a mass market version has been disclosed.
Feb. 18, 2014, 9:13 AM
- Medtronic's (MDT +0.2%) net profit slumps to $762M from $988M a year earlier, which included a tax benefit.
- Earnings also fell because Medtronic took charges for the failed trial of a therapy for high-blood pressure. The charges and other one-time items hit Medtronic's income by $0.16 a share.
- Sales breakdown: implantable cardioverter defibrillators flat at $655M; pacemakers -4% to $439M; structural heart products +3% to $281M; spinal products -1% to $744M; diabetes +16% to $436M.
- Emerging markets revenues +10% to $521M.
- Medtronic narrows its 2014 EPS guidance to $3.81-3.83 from a previous prediction of $3.80-3.85. The company still expects revenue growth of 3-4%. (PR)
Feb. 18, 2014, 7:26 AM
Feb. 18, 2014, 12:05 AM
Feb. 17, 2014, 5:30 PM
Jan. 28, 2014, 4:04 PM
- The system was approved for use in the treatment of type B aortic dissections.
- "Supported by the results of the U.S. Medtronic DISSECTION trial, the new indication expands treatment options for this challenging patient population by providing physicians with a minimally invasive alternative to open surgical repair and medical therapy."
- Medtronic (MDT +0.2%) press release
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.
Other News & PR