FDA OKs Medtronic system for atrial fibrillation

Medical device maker Medtronic Inc said U.S. regulators approved its new catheter system for treating a common heart rhythm disorder known as paroxysmal atrial fibrillation.

The Food and Drug Administration approved the Arctic Front Cardiac CryoAblation Catheter system, a non-invasive procedure that freezes and kills problem-causing heart tissue, the company said.

“I think it’s a big deal,” said Jan Wald, an analyst for Noble Financial Capital Markets, noting that it’s only the second catheter approved to treat atrial fibrillation.

“The physician community likes cryo. They consider it safe, and so from that perspective I think Medtronic has a good device on the market and will be able to take (market) share,” Wald said.

While catheter ablation is still a relatively small portion of an atrial fibrillation market dominated by drugs, Wald said he expects it to grow. Ablation is the destruction or removal of tissue.

In a pivotal clinical trial, the Medtronic system proved nearly 10 times better at eliminating the potentially serious heart rhythm disorder than conventional anti-arrhythmic drugs and appeared to be just as safe.

In the trial, nearly 70 percent of patients who underwent cryoablation using the Medtronic system remained free of the heart problem after one year, compared with about 7 percent of patients who received common drug therapy.

Atrial fibrillation is the most common heart disorder, affecting some 3 million Americans. It significantly raises the risk of stroke. Paroxysmal atrial fibrillation is a type of atrial fibrillation in which irregular heartbeats in the upper chambers start and stop suddenly on their own.

Medtronic’s balloon-based technology, which is delivered via a catheter inserted into a blood vessel and threaded to the heart, is novel because it uses a freezing technology on the affected heart tissue rather than more commonly used heat.

“It’s going to be a good product for them to break into the AF market in the U.S. for the first time,” said Gabelli & Co analyst Jeff Jonas. “It’s been successful for them in Europe.”

The Medtronic system was previously approved in Europe and Australia.

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By Bill Berkrot
NEW YORK