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.

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.

Topics: Enterprise Software


Dana Blankenhorn has been a business journalist since 1978, and has covered technology since 1982. He launched the Interactive Age Daily, the first daily coverage of the Internet to launch with a magazine, in September 1994.

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