AGA Medical

Photograph by Paul Sinkler

Franck Gougeon (left) and Dr. Kurt Amplatz built their medical-device company on the foundation of Amplatz's inventive mind.

Healthy Once Again

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Dr. Kurt Amplatz mends broken hearts. The 83-year-old Austria native invented the Amplatzer septal occluder, his company's flagship product, to close congenital atrial septal defects—holes in the wall between the upper chambers of the heart. His line of occluder devices, which are wire-mesh units filled with polyester fabric, have helped more than 100,000 children and adults avoid invasive surgery.

 

"Before we came out with those products, the gold standard for closure of atrial septal defects was open-heart surgery," says Franck Gougeon, president and CEO of Plymouth-based AGA Medical, which produces the occluders. "There was no other viable treatment."

These innovative products emerged from humble beginnings. In 1995, Amplatz rented warehouse space for $75 a month to create an experimental model of his first occluder. According to Amplatz, who was honored many times for his work during his 40 years as professor of radiology at the University of Minnesota, he had no choice but to start a new company when his experiment proved successful.

The medical-device company he founded was itself an experiment. Figuring he should be the only one gambling on the success of his products, he charged each of his two partners—Gougeon and Russian-born engineer Michael Afremov—$100 in return for a one-third share of the company. In 2002, after the septal occluder received FDA approval, AGA Medical posted $62 million in sales.

Later that year, the company suffered some well-publicized legal disputes between the partners. Nearly two years passed before Amplatz and Gougeon regained control of the company.

Today, those problems appear to be history. AGA Medical's implanted medical devices for repairing heart defects are now sold in more than 90 countries. Annual sales have increased more than 20 percent over the past few years; 2007 revenues are projected to exceed $120 million. Nearly 100 of the company's 300 employees have been added in the past 10 months. "We had to add a number of people in various departments just to be able to cope with the growth of the company, which is mainly R&D and quality driven," Gougeon says.

Although AGA's core business has been pediatric cardiology, the company is turning more of its attention to treating adults. "Congenital heart disease is a growing field, because as younger patients improve, they tend to grow up and reach adulthood, which in the last 20 years was not the case," Gougeon says.

AGA's occluding technology also could be used to treat strokes and migraine headaches. "We were occluding patients, who were then telling their physicians, 'I'm doing well after surgery, but I also used to have terrible migraines, and now they are gone or have been reduced considerably since I had the procedure done.' We are conducting trials to confirm this link," Gougeon says. "It [could] open the way for us to treat potentially millions of patients in the U.S. alone."

Amplatz himself is still busy in his workshop. "All the legal trouble is behind us now, and Kurt is back as the research scientist, working to develop new products," Gougeon says. "We have a large number of engineers who are backing him up, so he is able to get fully integrated in research. Thanks to Dr. Amplatz's innovative ideas, we have a large number of products in the pipeline, which are going to be spanning over different specialties."

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