Myxo Ring Dispute: Tale of Two Studies Plunges Northwestern's IRB Into Controversy
The review board at the heart of the Myxo controversy seemingly had guidance in place that should have triggered FDA notification and patient consent before a study of the device went ahead.
Grassley Investigation Unearths Second, Secret, Myxo Ring Study
The US Senate Judiciary Committee ranking Republican has opened a fresh can of worms in the long-running Myxo annuloplasty ring controversy, this time hinting that Northwestern withheld key materials.
Myxo Ring Controversy Reopened with New Questions From Sen Grassley
It was a 2008 heartwire story into the use and belated market clearance of the angioplasty ring that first prompted Sen Grassley to investigate. Six years later, he's asked for a fresh look.
Northwestern University denies tenure to Myxo ring whistleblower
In the latest twist in the "Myxo-ring mix-up" first reported by heartwire in 2008, Dr Nalini Rajamannan has had her tenure application denied by Northwestern, despite holding federal research grants funding her work through 2012. She believes an unreported ECG she uncovered during a Myxo procedure is at the heart of the decision, something Northwestern denies.
FDA recommends changes to 510(k) process
The FDA has issued two preliminary reports with recommendations on how to improve the so-called 510(k) process of medical devices that do not require the full premarket approval process.
FDA rebukes Edwards for late reporting of adverse events with valve devices, including Myxo ring
The FDA's warning letter demands that Edwards correct the "violation" that led to the late reporting of events. A response from Edwards, however, indicates that the company has already addressed the FDA's concerns.
Latest Grassley letter seeks clarity on 510(k) loophole through which Myxo ring went to market
The letter is the latest in a series from the senator's office probing the Myxo ETlogix annuloplasty ring—a device that made its way onto the market based on FDA guidance that Grassley has singled out as flawed.
Myxo ring controversy makes front-page news in Wall Street Journal
The twisted tale—first chronicled by heartwire—of the surgeon, the patient, the would-be whistleblower, and a kooky regulatory loophole that allowed a company to market a product without formal FDA permission has, nearly a year later, made front-page news.
theheart.org editor wins NIHCM journalism award
Shelley Wood, managing editor of theheart.org, has won a 2009 National Institute for Health Care Management Journalism and Research Award for her "Myxo ring mix-up" series.
US Senator questions FDA for letting Edwards "off the hook" over Myxo device
In a letter sent April 29 to the FDA, US Senator Chuck Grassley poses a range of questions dealing specifically with the FDA's handling of the Myxo case—including whether patients who'd received the ring had been informed of the situation—as well as probing the FDA's policies for determining when a new 510(k) is warranted.
FDA clears Myxo ETlogix valve ring under new name but disagrees with earlier decision by Edwards that device did not need 510(k)
UPDATED WITH ADDITIONAL COMMENTARY // After reviewing company documents, the FDA says the ring is safe and effective but says Edwards Lifesciences was "wrong" to commercialize the ring without appropriate clearance. The company will not face sanctions, however, since it made a good-faith effort to follow FDA guidance for devices with only minor modifications. The device will no longer be known as the "Myxo."
Myxo ring controversy spotlights regulatory gray area: When does a tweaked device constitute a new product?
UPDATED // Edwards Lifesciences says it followed FDA guidance to decide that its Myxo annuloplasty ring was similar enough to already-available rings to permit the company to market it without filing for a new device approval. But deciding when a device is "substantially equivalent" is an imperfect process, experts say.
Senate committee investigating Edwards, Northwestern, and FDA over Myxo annuloplasty ring
Sen Charles Grassley is asking for everything from paperwork detailing the approval status of the device to payments received by the university and surgeon/inventor Dr Patrick McCarthy to the university's treatment of the cardiologist who first raised an alarm about the device.
Questions raised about Northwestern use of valve device; prominent surgeon denies wrongdoing
Dr Patrick McCarthy and Edwards Lifesciences insist that the Myxo ETlogix annuloplasty ring 5100 that McCarthy invented was commercially available at the time it was used in a study describing the "initial experience" with the ring. The circumstances are now the subject of an FDA investigation and the focus of a lawsuit from a patient who says she was never told that McCarthy had invented the device.