Author Archives: Mark McCarty

Indispensably obsolete; the FDA warning letter

The FDA warning letter has been around for more than a quarter century, and questions about their use and abuse crop up periodically. Perhaps it’s time again to ask whether warning letters actually fulfill their purpose, but one gets the…

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Quick hits from ACC 2017

The news at ACC 2017 has varied by product type, including TAVR devices, coronary artery stents and imaging modalities, As usual, there are potential and verifiable winners and losers, and in some cases, companies playing catch-up with the competition in…

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FDA issues alert for Abbott GT1 due to MACE rate

The FDA issued a Medwatch alert on March 18, regarding the rate of major adverse cardiac events for the Absorb GT1 scaffold by Abbott Vascular, breaking an embargo placed on the news at the American College of Cardiology annual meeting….

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FDA’s off-label dilemma

As is widely known, the FDA is facing a change in leadership and has inked a memorandum staking out the agency’s current position on the off-label promotion problem. Despite the continued vetting of the problem by the agency, the memo…

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Hyperventilation; Reaction to the Cures Act

  There may be someone on the dark side of the Moon that hasn’t heard about the Senate vote for the 21st Century Cures Act, but everyone else certainly has. One might have expected the reaction to the Cures bill…

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Device flight round trips, and other matters

Never a dull moment in the world of medical devices and the Food and Drug Administration, is there? Sometimes the FDA is on the march, other times it seems the agency is about to be eclipsed by other forces. Don’t…

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Loose the clown posse; Uncle Sam has cancer fever

You have to hand it to the cancer lobby. It really has the U.S. federal government wrapped around its little finger. Some will say I’m overstating the case, but is that really a solid argument? Let’s examine the evidence. Mortality,…

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ACC 2016: All aboard the TAVR train

The Windy City really lived up to its name during the course of ACC 2016, didn’t it? It was also interesting to hear the recording on the subway stating that gambling is not allowed on the trains. Who knew? ACC…

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To IVUS or not to IVUS

Everyone has heard about the FDA advisory hearing for the Absorb scaffold by Abbott Vascular, but to recap, one of the issues that came up in connection with the trial data for the Absorb was the association between coronary artery…

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Abbott’s dilemma; Absorbing the Absorb

Now that Abbott Vascular has pulled out a resounding win at an FDA advisory committee for its Absorb bioresorbable scaffold, it’s time to ask what the coverage and reimbursement pictures look like. The coverage part looks easy – perhaps easier…

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