Volcano Corporation's intravascular ultrasound angioplasty balloon received CE mark approval, the San Diego, Calif-based company announced Wednesday.

Dubbed the Vibe RX Vascular Imaging Balloon Catheter, the joint diagnostic and therapy device features an IVUS scanner attached to a balloon catheter, to allow physicians to image blood vessels they're treating.

"VIBE(TM) RX represents the first of what we believe will be many Volcano image-guided therapy devices designed to allow physicians to see more detail right at the point of the therapy," Volcano President and CEO Scott Huennekens said in a statement.

The company said it completed its first clinical cases in New Zealand. It also predicts the platform will eventually have uses beyond cardiovascular ones.

Shipments for the device should begin in Europe by third quarter 2010, the company said.

But in a letter to investors Wednesday morning, health care investment bank Leerink Swann cautioned, "We expect Vibe's initial European and later on U.S. uptake to be relatively slow as IVUS penetration in these geographies is low."

The bank pointed out that reimbursements for the product were more favorable in Japan, and they expect a more significant reaction once it launches there, possibly by the middle of next year.

As for the United States, Volcano told DOTmed News it will be filing for investigational device exemption with the U.S. Food and Drug Administration in the coming months.

"We have not yet filed," Volcano spokeswoman Edrienne Brandon said. "We're doing an IDE submission later this year."

Volcano's stock rose slightly, around 1 percent, in recent trading, to hit $22.03 a share.

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