It can take years for the Food and Drug Administration to approve a new medical device. Critics say that's limiting important health care advances that could be saving lives today.
‘I just kept hanging on'
The main artery that carries blood from Jack Snyder's heart developed a serious problem. A section of his aorta was swelling like a balloon and ready to pop.
"I didn't know how long it would last, I just kept hanging on," he recalled.
In the past, doctors would've given Snyder two options: Do nothing and hope the aneurysm doesn't burst which could cause him to bleed to death internally, or open up his chest and try and fix it surgically.
However, with that choice given his current state of health is the real possibility he'd die on the operating table. Thanks to an FDA program to help fast-track new medical technologies, Snyder had another option. It involved a less invasive procedure to put in a test device designed to prevent the artery from rupturing.
The third option
To prepare for the operation, doctors at the Mayo Clinic used a 3-D printer to make a replica of Snyder's damaged aorta. They took the model and hooked it up to a pump to simulate Snyder's heartbeat and blood pressure. Then, they practiced inserting an experimental stent, a tube-like device, inside the aneurysm. It's a risky and tricky maneuver.
For the real procedure, doctors cut a small opening in Snyder's arm and threaded the stent through a blood vessel into his bulging aorta, so the blood could flow inside the stent and no longer in the aneurysm.
What's next for Fast Track
The FDA allowed Mayo to use the experimental stent because of the seriousness of this case. There was nothing else available. What's learned from this test run about the device's safety and effectiveness could eventually speed up its approval for widespread use.
Mayo is one of five sites in the United States taking part in this fast track approach.
Snyder was able to leave the hospital after just a few days. Doctors will continue to monitor how well the stent is holding up, but for now, that ticking time bomb of an aneurysm is no longer such an ominous threat.