Posts Tagged ‘NMT Medical’
David Dansereau decided to go for the procedure rather than wait
Every year, experts estimate, about 80,000 seemingly healthy people in this country under the age of 55 have a stroke for no apparent reason. Some researchers have long suspected that one culprit is a cardiac defect that 40 percent of those people share — a tiny congenital opening between the upper chambers of their hearts.
Based on that theory, doctors in recent years have implanted a small flexible seal in the hearts of thousands of stroke patients. The idea is that closing the hole will prevent future strokes by blocking a pathway for blood clots.
Such devices are not currently approved by federal regulators for that procedure, which can cost up to $30,000. And there is a bigger problem. It is not clear whether the implants actually help stroke victims — or might even harm some of them. Because the devices have been used so widely, it has been difficult to find enough untreated patients to mount a study to prove their effectiveness and safety.
It is not unusual for medical practice to run ahead of scientific findings. But the hole-closing heart device is a case study of how the actions of doctors, regulators, device makers and patients themselves can combine to undercut the gathering of reliable medical evidence…
Stroke experts are sharply split about the device’s value — which is why, regardless of their view, they agree it is urgent for such trials to be conducted, to prove or disprove the benefit to stroke patients…
“Even if the answers are not clear-cut, at least it will give doctors and patients a sense of what they are dealing with,” said Maisel, the cardiologist in Boston.
If I had the problem, I guess I’d read up on what study information already exists. Though I’m not convinced the FDA earns it’s role as health overseer – especially in recent years – it’s the only official game in town.