MedicalCV expects to launch Atrilaze atrial fibrillation treatment in second half of '06

By Jennifer Lanning Drey

Eugene, Ore., July 12 - MedicalCV expects to launch its Atrilaze Minimally Invasive System in the second half of the year, according to Marc Flores, chief executive officer of the company.

The company submitted a 510(k) application to the Food and Drug Administration in late May and expects to have a response soon, Flores said Wednesday at the C.E. Unterberg Emerging Growth Opportunities Conference.

The Atrilaze Minimally Invasive System is a laser-based system designed to enable access to and ablation of cardiac tissue for the potential treatment of atrial fibrillation (AF) in a closed-chest beating heart setting.

"If we do what we're saying and provide the market with a minimally invasive solution for the treatment of AF, on its most conservative basis, that is a $2.1 billion market," said Flores.

MedicalCV estimates that there are at least 5 million people worldwide with AF. Half of them are Americans, Flores said.

The company also said AF is the most commonly occurring cardiac arrhythmia.

"The incidence of AF also increases with age, and last time I checked, here in the States, the population was aging," he said.

The company plans to perform additional studies on the device in animals and humans once the system is launched.

MedicalCV also hopes to expand its labeling to include a specific indication for AF, said Flores.

MedicalCV believes its Atrilaze Minimally Invasive System will be able to successfully compete with drugs and procedures currently on the market because it is less invasive and would offer a better success rate that the drugs typically used to treat AF.

"The physics of lasers are such that we have an incredibly powerful tool at our disposal for blading cardiac tissue while the heart is beating," said Adam L. Berman, vice president of research and development at MedicalCV, on Wednesday.

"We truly have a customized energy source for arterial tissue that can be used on the beating or arrested heart. It lends itself incredibly well to a minimally invasive closed chest delivery system."

MedicalCV is an Inver Grove Heights, Minn.-based cardiovascular surgery company that develops products for the early treatment of cardiovascular disorders and disease.

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