Failed medical device trial leaves Gilbert man facing death (+ video)

Tommy Taylor is staring death in the face, buoyed by his strong Christian faith but full of anguish that he likely won’t be able to watch his grandchildren grow up.

The 59-year-old Gilbert resident faces the dilemma as a clinical trial for a medical device that has helped keep him alive for six years ends. Unfortunately, the neo Legacy, which pumps the blood in his carotid arteries, didn’t gain approval from the U.S. Food and Drug Administration.

Without the pump to control the flow, his blood pressure quickly soars to dangerously high levels.

As the trial ended, device maker CVRx gave participants three options. The company will pay for removal of the devices through April 1. The participants can keep the device in their bodies, working until the battery dies in less than a year. Or the participants can replace the devices at their own expense every 12 to 14 months.

Taylor says he can’t afford the nearly $400,000 expense he has been quoted for the replacement surgery, which Medicare to this point has refused to cover. He sees his only choice as having the device removed next week in North Carolina, which likely is a death sentence.

“I need a miracle,” said Taylor, a devout Christian who performed in traveling gospel groups for years. “Without God’s intervention, I will not live to see it back to Columbia S.C.”

Officials at CVRx, based in Minneapolis, said the original trial agreement stated that patients would be followed and the device maintained for five years or until it gained FDA approval, said company spokesman Tom Moore. When that approval didn’t come through, the company convinced the FDA to grant a humanitarian exemption for clinical trial participants. That allows doctors to replace the device when necessary.

The company didn’t agree to pay for maintenance or replacement of the device after the trial period. Moore said the $400,000 price tag Taylor mentioned for the surgery is much higher than he would have expected based on procedures for similar heart devices. Also, the company was told “there are pathways for Medicare to cover devices which have received (humanitarian) approvals,” Moore said.

Taylor said the problem is he was given the three options and had less than two weeks to make a decision. He has contacted U.S. Rep. Joe Wilson’s office for help with Medicare, and that didn’t help.

Taylor said he was assured CVRx would cover the cost until the device gained FDA approval or the company went bankrupt.

“Part of me is thankful that I got to live six more years, but now I’m being treated like a lab rat,” Taylor said. “My name is Tommy Taylor. With them I’m a number, 13685. I don’t even have a name. They don’t know who Tommy Taylor is, and I think they could care less.”

He has had to talk through the situation and his likely death with his wife, his three daughters, his parents and even his four grandchildren. The emotions of the past few weeks have left him raw.

“I feel like a prisoner that’s committed a crime and has an execution date,” he said, “except I’m not a prisoner, and I’ve committed no crime, but yet I still have an execution date.”

Unless there’s some kind of breakthrough in the coming days, Taylor is scheduled to have the device removed the morning of March 26 at Forsyth Medical Center in Winston-Salem., N.C. The last time doctors briefly turned off the device to see how his body would react, his blood pressure quickly skyrocketed to 350 over 245, he said. Arrangements are being made to rush Taylor back to the Palmetto Health Heart Hospital, but there’s no guarantee he can make it.

Until a few years ago, Taylor had been very healthy, even running distance races. Then one day on a training run through Lexington County, he suddenly couldn’t go on. His blood pressure was running out of control. Doctors at some of the top hospitals in the country couldn’t come up with a solution.

Then Taylor noticed an online article about a study in Europe of the CVRx device, and it mentioned the maker was looking for participants for a U.S. trial. Taylor signed up for the trial, and the device worked wonders for his situation.

Impulses are sent from the neo Legacy controller in the chest to wires along the carotid arteries. The arteries are squeezed to control blood flow. Taylor says it feels like someone is choking him.

“It was working so good for me, they called me their poster child,” Taylor said. “They were talking about using me in videos to promote their device.”

But it didn’t meet all of the requirements for FDA approval. Taylor can’t fault the FDA, which is looking out for the health of everyone. He just knows his health is in extreme jeopardy.

“It’s hard to accept that the 26th, without a miracle, I won’t be here,” Taylor said. “I won’t see my grandkids. I’m ready to go, but I’d like to stay here longer.”

This story was originally published March 17, 2015 at 8:22 PM with the headline "Failed medical device trial leaves Gilbert man facing death (+ video)."