Label expansion for CoreValve System

The FDA approves Medtronic's (MDT -0.6%) transcatheter aortic valve replacement (TAVR) CoreValve System for patients at high risk for open-heart surgery. Its original indication, approved in January 2014, is for patients at extreme risk for open-heart surgery. The basis for the expanded label was a Phase 3 clinical trial comparing TAVR using CoreValve to traditional surgical aortic valve replacement. One-year survival in patients receiving the CoreValve System was 85.8% vs 80.9% for patients receiving the traditional procedure. The results were statistically significant.

The Medtronic device competes directly with Edwards Lifesciences' (EW -3.1%) Sapien TAVR system. Last month, MDT agreed to pay EW $750M plus royalties to settle patent infringement claims.

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Comments (5)
  • donzoamania
    , contributor
    Comments (944) | Send Message
    Ew management has been totally swindled by MDT. MDT knee the dummies would settle EVEN AFTER A COMPLETE LEGAL VICTORY and ew has snatched defeat from the mouth of victory. Ew should withdraw the settlement offer after the judge involved in issuing the injunction was found to have ties to the MDT lawyer. Ew is wasting their
    patents and technological lead. Insiders have already sold and made themselves rich. The BOD is asleep here as with most companies these days. A real shame.
    12 Jun 2014, 08:47 PM Reply Like
  • tlc8386
    , contributor
    Comments (109) | Send Message
    The EW product is superior even with the patent infringement so no need to kill off MDT and risk monopoly status. Doctors know they can read the results and they will choose the better product for their patients. EW takes in the reward for theft and still is number one. The market is large enough for others problem is their products aren't any better. They will keep trying to improve so it's good for the patients.
    13 Jun 2014, 10:50 AM Reply Like
  • RetireRichie
    , contributor
    Comments (5) | Send Message
    After listening to EW present at the Jefferies Conference, I felt confident that EW is in the game to WIN. They have made great strides in perfecting their valves recently and this will translate to more market share. Doctors will have to pick the valve replacement they feel confident in. MDT will continue to sell the valve sizes that EW does not support today, but overall EW should come out the leader in the industry. Having said that, EW also mentioned at the conference that only about 2 valve manufactures will still be around when the dust settles. This is a long term process with competitors entering. In conclusion, I think we have seen stock holders making quick decisions to sell when news about MDT or St. Jude appears. These quick decisions in my opinion do not weigh in the work EW is doing presently and EW is positioning themselves for the near future. Possibly we may need to wait for 2015 but I believe the same as the many analysts that raised their targets for EW to above 90 and even 96/share within the last couple days.
    13 Jun 2014, 11:36 AM Reply Like
  • tlc8386
    , contributor
    Comments (109) | Send Message
    MDT has a huge wall to climb not only do they have to pay Edwards a great deal of money they have to convince doctors their product is better. Tough job ahead!!
    13 Jun 2014, 11:49 AM Reply Like
  • tlc8386
    , contributor
    Comments (109) | Send Message
    Mdt has a huge wall to climb not only do they have to pay Edwards a huge sum of money they have to try and create a better product which they have failed to do so. Doctors can read the stats they know which product will be best for their patient. A good surgeon will pick the best one you can't change real results and you can't buy them. It's a big win for Edwards not a loss and surely not a shame.
    13 Jun 2014, 11:53 AM Reply Like
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