In 2008, a heartwire investigation reported on a mitral annuloplasty ring, invented by a prominent surgeon, that one patient believed she'd received without giving informed consent. The device ultimately traveled an unusual path to FDA clearance, but not before attracting the attention of Congress.
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.
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.
The letter is the latest in a series from the senator's office probing the Myxo ETlogix annuloplasty ringa device that made its way onto the market based on FDA guidance that Grassley has singled out as flawed.
The twisted talefirst chronicled by heartwireof 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.
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 caseincluding whether patients who'd received the ring had been informed of the situationas well as probing the FDA's policies for determining when a new 510(k) is warranted.
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."
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.
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.
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.