MedicalCV seeks FDA approval of Atrilaze atrial fibrillation treatment

By Angela McDaniels

Seattle, May 31 - MedicalCV Inc. said it submitted a 510(k) application to the Food and Drug Administration seeking marketing clearance for the Atrilaze Minimally Invasive System, a laser-based system designed to enable access to and ablation of cardiac tissue for the potential treatment of atrial fibrillation in a closed-chest beating heart setting.

Atrial fibrillation is an erratic heartbeat and is the most commonly occurring cardiac arrhythmia, according to a company news release. It alters normal cardiac function, is a major precursor to congestive heart failure and is associated with an increased incidence of stroke.

There are four primary treatments for atrial fibrillation that use drugs, implantable devices, catheter-based treatments and open-chest surgery. MedicalCV said it expects its Atrilaze system to allow surgeons to complete an ablation procedure that will produce lesions that mimic those obtained by using the classic Maze surgical procedure, which is the standard of care.

Under the Atrilaze procedure, surgeons access the heart through three 1 cm incisions and use an automated laser guide and software-driven ablation sequence, which should last 15 minutes or less.

"In contrast to the existing, lengthy, invasive surgical and catheter-based treatments, we expect that the ablation procedure utilizing our Atrilaze system can be completed in one to two hours, with less pain to the patient and a shorter recovery period," president and chief executive officer Marc Flores said in the release.

Pending FDA approval, the company plans to begin marketing the system in the second half of 2006.

According to release, there are more than 5 million people with atrial fibrillation worldwide, including more than 2.5 million in the United States. The company believes that the total addressable market for a stand-alone, minimally invasive cardiac ablation procedure, which the Atrilaze system provides, is more than $2 billion.

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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