Tweezers

The new Broadway musical Hamilton has taken the theatre world by storm. A mix of hip-hop, rap and traditional theatre music tells the life of American Founding Father Alexander Hamilton, Washington’s right hand man during the Revolutionary War and founder of the Treasury among several other accomplishments.
So with all things early Americana on my mind I can’t help but compare Revolutionary times to the wild history of a revolutionary cardiovascular device. I’m talking about Boston Scientific’s WATCHMAN left atrial appendage closure device which will be reimbursed by Medicare. The device, the first of its type to be approved in the US after six years of regulatory limbo, is implanted in the heart to prevent strokes for atrial fibrillation (AF) patients. It is meant to be a second line therapy when medication is no longer a feasible treatment option.
Eighteenth century European Enlightenment ideals informed the Founding Fathers, and the early clinical experiences with the WATCHMAN device also took place in Europe where regulatory approval is easy to get. In Europe modern ideas about liberty, representative government, and science took shape. WATCHMAN has had approval in Europe for a decade, serving as the source of rumblings of new ideas of replacing pharmacotherapy with device therapy for AF stroke prevention.
However, in the medtech industry if you want grand success you need US sales. Enlightenment ideals were first applied on a grand scale with signing of the Declaration of Independence, but it was still only an early step in ousting British influence from the thirteen colonies. WATCHMAN arrived with its long awaited FDA approval last March, acting as a sort of declaration but not solidifying its presence in American medical practice. The Centers for Medicare and Medicaid Services (CMS) needed to decide whether or not the government would pay for the device, leaving WATCHMAN to fight for itself in a hostile reimbursement landscape. Like in the Revolutionary War, the odds of success were not guaranteed from the outset. In fact, a preliminary CMS coverage determination in October proposed several limitations WATCHMAN’s use.
But Providence was on Washington’s and WATCHMAN’s side. CMS’s listed requirements for payment, which are fairly lenient, act like a constitution for this new device market. It describes what subset of patients to treat, how and who is to make a treatment decision, who is allowed to perform the implant and the details of a registry to track outcomes. It is a sound system of checks and balances to prevent unnecessary implants, ensure patient safety and to see if the device is doing good.
This device market, which currently is only WATCHMAN in the US, is finally born. It has a solid foundation and a large patient population to manifest destiny. The future looks bright indeed.
Alas, a civil war is on the horizon for the left atrial appendage closure market. St. Jude Medical has its own device and is planning to get FDA approval in 2017, at which time the US market will be split in two.
America will benefit from this future conflict between Boston Scientific and St Jude. There will be more device choice, features and lower prices. Let Freedom Ring.

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