Look for that Canadian seal of approval

Look for that Canadian seal of approval

Summary: Medtronic's approval in Canada means hospitals can start using it now to reduce their backlogs of atrial fibrillation cases. The same system still has only investigatory approval in the U.S.

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TOPICS: Health
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Yesterday Medtronic issued a press release trumpeting the approval of its Cardiac Ablation System from Health Canada.

It's a bigger story than you realize.

The story here isn't about the device, which is indeed pretty cool. Cardiac ablation involves using radio waves to stop short circuits within the heart, halting the fast heartbeats of atrial fibrillation by suspending the electrical impulses from damaged tissue, burning them away.

With the Medtronic system all this can be done without open heart surgery. Medtronic developed its system by buying two companies, CryoCath Technologies of Canada and Ablation Frontiers of the U.S.

Why is the Canada approval important? Because it means more than what an FDA approval means, namely that the technique works. It means the treatment is cost-effective. It means sales, not just the promise of sales.

Medtronic's efforts to use its U.S. FDA approval and market the system have come under scrutiny, but Medtronic insists it doesn't want the states involved in deciding where and when such systems will be used. It wants a single federal standard.

Like they have in Canada.

All this is something of a sea change for device makers. Like drug makers they have in the past enjoyed many benefits from the U.S. regulatory system. Once the FDA approves it, you market it.

But now that is becoming problematic, as under health reform states have retained their power to decide what is-and-isn't covered by insurance. And it's payments that drive the market, not approvals.

Medtronic's approval in Canada means hospitals like the Southlake Medical Center in Newmarket, Ontario can start using it now to reduce their backlogs of atrial fibrillation cases.

Meanwhile, the same system still has only investigatory approval in the U.S. and, even after its approval by the FDA, the company still has to worry about state insurance commissioners as it seeks customers.

All of which has Medtronic singing Oh Canada. Expect more to join the chorus, as it becomes evident that the U.S. is no longer the fast-acting market it was before health reform.

Topic: Health

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19 comments
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  • Health Care Reform Has Nothing To Do With This

    "States have retained their power to decide what is-and-isn?t covered by insurance. "Retained" means it existed before health care reform.

    And while it's true that "it?s payments that drive the market, not approvals," good luck getting any state to require payments for something the FDA hasn't approved. That has never been a speedy process, either (http://www.ncpa.org/sub/dpd/index.php?Article_ID=5890). Maybe you're missing a ;) after your last paragraph?
    MichP
    • RE: Look for that Canadian seal of approval

      @MichP You're right about insurance. On both counts. But the procedure itself is covered. I think what Medtronic is upset about is states getting involved with how the procedure is done.
      DanaBlankenhorn
    • RE: Look for that Canadian seal of approval

      @MichP Much of the appeal of the Canadian system is that it seems to do more for less. Canada provides universal access to health care for its citizens, while nearly one in five non-elderly Americans is uninsured. Canada spends far less of its GDP on health care (10.4 percent, ver-sus 16 percent in the U.S.) yet performs better than the U.S. on two commonly cited health outcome measures, the infant mortality rate and life expectancy. <a style="text-decoration: none; color: #333333;" href="http://www.the-toronto-realestate.com/">Toronto real estate</a>
      starksdev305
  • Canada... National approval of safety, Provincial choice of paying...

    Health Canada says what is safe, but the provinces control the health insurance... However, if something is approved safe, and would cut costs/wait times? You can be sure that it's going to be implemented right away, as the insurance is based on what is treated, not how it is treated.

    ...or at least, that's how it was explained when I asked my doctor.
    shryko
    • RE: Look for that Canadian seal of approval

      @shryko
      That's what I was told too. I was talking to an ER doctor at one of our local hospitals. He said the difference is in how much insurance gets billed, which depends on the state that you live in. In states like Florida, health care professionals get paid by the procedure. In states like Minnesota, most health care professionals are on salary. That is why health care costs are significantly lower for states like Minnesota than they are for states like Florida or South Carolina. My two cents, I think it's great that congress wants to make sure that everyone has access to affordable health care. I don't think the current solution takes care of the real problem though, namely, the high cost of health care. If I were a health insurance CEO, I would be paying my customers to price shop for health care. Cut them in at 50% of the savings. They save money, I save money, and the cost of health care goes down. There also probably needs to be some standardization on how health care professionals are compensated. I'm sure that are many other things we could do differently too.
      deekm
      • RE: Look for that Canadian seal of approval

        @deekm One thing I've written about here and at SmartPlanet is the idea of medical tourism. Companies that fund their own health care (usually through an insurance company) can offer this to their employees, and as you say split the difference on savings.
        DanaBlankenhorn
    • RE: Look for that Canadian seal of approval

      @shryko You're right as well. In Canada the provision of health care is provincial matter. But as I noted Medtronic also had a sale to report along with the approval...
      DanaBlankenhorn
      • RE: Look for that Canadian seal of approval

        @DanaBlankenhorn I don't understand the States medical system, but what we have in Australia is a national government sponsored basic healthcare. What that means is you can go to a public hospital, get treated by what ever doctor is available. This is covered by your taxes. However waiting lists for elective surgery, dental, anything not life threatening are long, and may take months to happen.

        If you want your own doctor, own room in hospital, private hospital, chiropractor, dentist (more than absolute basic), nose job, etc then you must pay.

        You can take out private health insurance to cover most of those expenses. This is actively encouraged by the government through tax deductions, and penalised by extra "taxes" if you don't have cover after you turn 30.

        An interesting byproduct of government funded health is that they want the population to be healthy. SO...

        Start banning tobacco as soon as possible.
        Create laws for wearing seatbelts, wearing push bike and motor bike helmets.
        Pressure on fast food companies to stop obesity, amongst others.
        Active and constant advertising against drugs. (I don't know how much it works but they try)

        Anything to reduce the cost of supplying that health care!
        I am Gorby
  • RE: Look for that Canadian seal of approval

    I have had oblation the old fashioned way. I spent 4 days in Kingston and was not in very good condition for about six weeks after. It was an invasive procedure.

    If Canada can fast track procedures that cost less and are more accurate, and other countries think that, then why not? I think that there should be an open border of trade between countries. Medtronic is just making sure that they financially survive. It makes perfect sense.
    bwarren3
  • RE: Look for that Canadian seal of approval

    There is a lot of confusion in the US about the Canadian Health System, first of all our system is paid for from taxes in fact it is where the greatest amount of tax dollars are spent both at the federal and provincial levels. Health Canada is responsible for several things, mainly drug approval, they are far more cautious than the FDA (FDA has approved drugs that are not approved for use in Canada), they approve medical procedures and only then will Provinces consider paying for them, like drugs they also approve medical equipment, but its distribution is dependant on funds availability, hospitals have to weigh patient care against getting the latest and greatest. Health Canada has a primary purpose and that is to ensure that medical care is available equally to all Canadians from the poorest to the richest, we try not to have a two tier system of health care. Our system is so egalitarian that patients have been cared for in the US at government expence because a treatment is so rare or experimental and is not offered in Canada. One thing is that our system is not subject to is an Insurer dictating who we can visit, what will be covered and where we will be treated, our system's focus is on saving lives regardless of social strata and whether or not you can pay. No one dies from a ruptured appendix because they don't have insurance or can't pay to have it removed.
    Rndmacts
    • RE: Look for that Canadian seal of approval

      @Rndmacts

      Amen. Corporations never had influence when the system was created in Canada. The root of all the problems in USA is corporate greed first.
      czorrilla
      • RE: Look for that Canadian seal of approval

        @czorrilla: You are not entirely correct. Corporations had less influence when Medicare was introduced in Canada - but they, and the doctors' lobbies, campaigned long and bitterly. There was even a doctor's strike (http://medicare.ca/main/the-facts/the-history-of-medicare, http://www.thecanadianencyclopedia.com/index.cfm?PgNm=TCE&Params=A1ARTA0003658).
        Marc Erickson
    • Thanks for the explanation

      @Rndmacts When I get called "socialist" or "communist" because I saw a need for health reform and said so, I like to think about Canada. Yes, there are problems and controversies there, but I don't see a rush to switch to a US system. In fact I don't see such a rush in any place American conservatives condemn so vigorously, and warn about so avidly.
      DanaBlankenhorn
    • RE: Look for that Canadian seal of approval

      @Rndmacts wrote: " Health Canada has a primary purpose and that is to ensure that medical care is available equally to all Canadians from the poorest to the richest, we try not to have a two tier system of health care."

      Does this mean that everyone will have the *best* available care? Probably NOT. Egalitarianism leads to a leveling--nobody goes without, but nobody gets the best, either.

      Or, as another Canadian wrote, "The trees are all kept equal...by hatchet, axe, and saw!"
      jabster17
      • RE: Look for that Canadian seal of approval

        @jabster17 It's true that America is far less equal in many ways than Canada. Canada's economy is also much stronger than that of the U.S. right now. So what's your point, that the rich deserve to live longer because they're rich?
        DanaBlankenhorn
      • BEST care? Who can get it in the US anyway?

        @jabster17 wrote "Does this mean that everyone will have the *best* available care? Probably NOT. Egalitarianism leads to a leveling--nobody goes without, but nobody gets the best, either."

        On the other hand, the BEST care can sometimes only prolong your life by a few weeks and the marginal cost is very high. Single-payer insurance systems (such as the Canadian, Australian and UK ones) have to be careful about cost-effectiveness for treatments, more than private insurances do. So, yes, you do not get the BEST care for everybody.

        But, let's face it, you don't in the US either. It would depend on your insurance : pre-existing conditions are not covered, insurances restrict who you can see, they restrict how many times you can go, they restrict which procedures can be done, etc. Only those that can pay out of pocket can get the *best* care in the US. So the best care argument in a false one.

        Those that *are* rich enough to get the best care (out of their own pocket) do like in the US, they shop around and get their procedures done in India, in Cuba, in Turkey, and, maybe (just maybe) in the US. The US comes last because of the cost.

        It does say something when it is more cost effective to get a procedure done in India (with a plane ticket of upwards to 2000$ per person from Ontario or Quebec, assuming you go First Class, and, IMO you should if you're sick enough to consider going abroad), with an expertise level more than acceptable, including the cost of minimum stay after the procedure and a few weeks of vacation, than to have it done by our southern neighbors.

        tl;dr version: *Best* care is not a viable argument, as evidenced by horror stories (which include price of insurance) of insurance problems in the US. The US health care is so expensive that it is cheaper to get treated elsewhere.
        Zahra B.
  • The FDA has dragged for a long time

    Dana:

    "All of which has Medtronic singing Oh Canada. Expect more to join the chorus, as it becomes evident that the U.S. is no longer the fast-acting market it was before health reform."

    isn't accurate. The FDA has been slow for years (since thalidomide) and at times follows the rest of the world by years.

    The nice thing about the Canadian approval for this device is the Yanks can now travel to Canada for faster, better and less expensive treatment. Odd situation after the arguments during the health reform development.
    Ken_z
    • RE: Look for that Canadian seal of approval

      @Ken_z Most releases I get here trumpet FDA approval, usually device approval. But device approval only gives you the right to market. In the case of this Canadian approval, it came with a sale, and the prospect of many more, given that this improves care while lowering costs.
      DanaBlankenhorn
      • An interesting story

        @DanaBlankenhorn

        A dozen or so years ago there was a great story in the WSJ on a product called the "Sensor Pad"

        One review of the story:

        http://www.fdareview.org/devices.shtml

        Or you can read the story directly if you have access, maybe through a library.
        Ken_z