Fantastic Voyage

After the call, Cummins tells his executives, "Now all we need to do is deliver on our revised promises. It wouldn't be good to change them again in three weeks," when the company will hold its regularly scheduled third-quarter earnings call. Heading back to his office, Totah is confident in his interpretation of the FDA's next move. He says that with 30 years of device experience, understanding the workings of the agency no longer feels like Vatican-watching.

"Such a little girl," the surgeon murmurs as he slips the device into her chest. "I want to get it nicely under the muscle" so it's less visible beneath her skin.

But the next day, in an interview, Terry, the founder who now sits on the company's board, sounds apprehensive about trying to read too much into the FDA's tea leaves. "I didn't understand it," he says of the guesswork presented in the conference call. "There was no announcement from the FDA. This is really just our best estimate." Later in January, Terry's conservatism is borne out. The FDA cancels its April panel meeting--the one Totah had predicted Cyberonics would attend--without explanation. Cyberonics is also forced to change its financial projections again, for the worse. It starts talking about a July date with the FDA, and the stock sinks.

In Operating Room 22, Madsen and Cahill are fishing for the vagus nerve. It's not always easy to find. The nerve itself is a whitish-yellow cord, about the width of a cocktail straw. It runs alongside the carotid artery and the jugular vein--treacherous terrain.

The surgeons loosely loop a strand of blue surgical thread behind the nerve to keep it separated out from the blood vessels. The most delicate part of the procedure involves wrapping three tiny coils around the nerve. The coils, which will deliver the electrical impulses from the generator, look very much like the tiny metal spring inside a ballpoint pen. "It's a tiny little procedure," says Cahill, the surgical resident. "You just focus very hard on what you're doing." As he's wrapping the coils around the nerve, it looks like he's tying a fly.

They thread the wire from the incision in Jordyn's neck down to her armpit. There, Madsen plugs the wire into the titanium-encased generator, and using a small screwdriver, he turns a screw until he hears two clicks, indicating that the wire is tightly connected. He slides the generator into a small pocket he's created in the flesh, and in a few seconds, it has disappeared underneath Jordyn's pectoral muscle, like a shiny coin in a magic routine. "Such a little girl," Madsen says. "I want to get it nicely under the muscle," so that the device isn't very visible beneath her skin.

Before they close the incisions, Madsen picks up a Dell handheld computer that's used, with a Cyberonics-designed "programming wand," to test the VNS device and make sure that the generator, the wire, and the coils are all working properly. In rare instances, the test, which sends a large electrical impulse through the system, can cause the patient's heart rate to drop, so the anesthesiologist stands at the ready.

Madsen looks puzzled. "This came back as 'high impedance.' "

"Oh, that's not good," Cahill says. The electrical current isn't flowing properly along the circuit that runs from the generator to the vagus nerve. "We may need to open this back up and fiddle with it," Madsen says. "There's something wrong with the way it's interpreting the connection. It could be the [wire] or the generator that's a problem." Madsen and Cahill seem miffed; they thought they were in the home stretch. Madsen asks a nurse to make sure that the hospital has a spare VNS device on hand in case this first one proves defective.

Madsen proceeds to pull the generator out of Jordyn's chest, and starts to troubleshoot. "We want to localize the electronic problem to the generator or the cables," he says. He unplugs the wire, wipes it off, and plugs it back in. Cahill holds the generator in his hand, and Madsen tests it again with the computer and wand setup. He clicks the computer's touch screen with a silver surgical clamp; it emits a faint chime, and they wait for the diagnostic to run again. A segmented progress bar creeps across the screen. "Now it says the impedance is okay," Madsen says. He still can't figure out what

exactly happened: "It could be that the screw didn't seat right."

He puts the device back into Jordyn's chest and tests it again. It's fine. They start to close the two incisions, using dissolving sutures on the inside and a surgical glue on the outside.

Madsen, with some 500 VNS implants and replacements under his belt, says, "I have not seen that particular thing happen in just that way." But the patient is in good shape. It'll take a few weeks to see whether the device reduces Jordyn's seizures, though, as the amount of electrical stimulation is progressively increased.

A half hour later, the patient is resting in a postoperative recovery room. She's expected to go home the following morning. (Many recipients of the VNS device go home the same day.) With her mother and father standing next to her bed, Jordyn's eyelids flutter open for a second--and then she goes back to sleep. nFC

Scott Kirsner writes about technology from Boston.