Local doctor’s research leads to approval of new cardiac device

For the past 16 years Wayne Bromen has had a pain in the heart.

Wayne Bromen smiles as his cardiologist, Dr. Jeffrey Chambers (right) shows him a video demonstration of the procedure used to open his blocked arteries. Photo by Sue Austreng

Wayne Bromen smiles as his cardiologist, Dr. Jeffrey Chambers (right) shows him a video demonstration of the procedure used to open his blocked arteries. Photo by Sue Austreng

The 73-year-old Coon Rapids man suffers from coronary artery disease, underwent quadruple bypass surgery in 1997 and has had seven stents inserted into his arteries.

There were few options left to keep his calcified arteries open and pumping blood to his heart. And then a new device received Federal Drug Administration approval Oct. 21. Two days later, Dr. Jeffrey Chambers used that brand new device to unclog Bromen’s arteries and today, the pain in his heart has been relieved.

“If you weren’t around, I wouldn’t be here – permanently,” Bromen said to Chambers last week, relaxing in Chambers’ office at the Metropolitan Heart and Vascular Institute at Mercy Hospital in Coon Rapids.

In fact, Chambers, an interventional cardiologist at the heart institute and frequent researcher who has spoken internationally on new treatments for heart disease, was the principal investigator during clinical trials for the new device.

As Bromen’s cardiologist for the past 16 years, Chambers knew the device could work wonders for him.

“The tube is inserted into the artery, then it spins around and orbits and sands the calcium out,” Chambers said, describing the calcium-clearing action of the device, called the Diamondback 360 Coronary Orbital Atherectomy System.

“The average treatment time is less than one minute,”

But Bromen simply calls it a life saver.

“If it weren’t for you, if it weren’t for that tool, I’d be in pretty sorry shape,” Bromen said. “I probably wouldn’t be here right now.”

Bromen is the first Minnesotan and one of the first in the nation to have the procedure with the Diamondback 360, which is currently being gradually launched at other facilities, Chambers said.

And the cardiologist expects the Diamondback 360 to be the go-to device in treating calcium build up.

“If we see people with a lot of calcium build up, we’ll do this. We’ll use this device and hopefully this will change the way we treat people,” Chambers said.

According to literature released by Cardiovascular Systems, Inc., which developed the Diamondback 360, heart disease causes 600,000 deaths in the United States every year and the FDA approval of the device can save thousands of lives.

“It’s a potentially lifesaving development for the estimated 16.8 million people in the United States who suffer from coronary artery disease, the most common form of heart disease,” said Jim Engel, spokesman for the Metropolitan Heart and Vascular Institute.

David Martin, president and chief executive officer of Cardiovascular Systems, further described the advantage of the Diamondback 360.

“Severe coronary arterial calcium is an underestimated problem in medicine, with limited options for treatment. The … trial proved our Diamondback technology is safe and effective in treating this complex disease,” Martin said.

For Bromen, the Diamondback 360 means new energy, new activity, new life.

He described his “pain in the heart” life before the life-changing procedure.

Back in 1997, he and his wife had gone on an Alaskan cruise. The last day of the land and sea adventure included a five-mile hike to watch the salmon run.

“It was two and a half miles one way – the last part down a steep decline – and then two and a half miles back,” Bromen said.

“Well, I couldn’t make it back up. I could only go maybe 50 feet, then have to stop and rest, catch my breath and wait until I could go another 50 feet. I knew something wasn’t right.”

Even after his quadruple bypass surgery, his arteries became severely calcified several times, hence the insertion of the seven stents.

But after the Oct. 23 procedure using the Diamondback 360, Bromen felt like a new man, full of energy and without any pain.

“Now we’re planning a trip to east Texas,” he said. “We’ll do a lot of hiking, exploring, see what’s over there.

“We’ll probably take a month, maybe six weeks. It’ll be a great trip.”

His cardiologist smiled along with Bromen, pleased at the success of the newly-approved device.

“It’s all about getting people to feel better and live a full life,” Chambers said.

Sue Austreng is at sue.austreng@ecm-inc.com

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