TriVascular trials progress in Europe

Stent-maker expects to hire 100, begins first marketing effort

[caption id="attachment_19675" align="alignleft" width="288" caption="The Ovation abdominal stent graft is showing stellar results in European trials."][/caption]

SANTA ROSA -- TriVascular's abdominal stent graft is showing solid results in European clinical trials, well on its way to holding a leading position in a predicted $2 billion global market.

To deal with anticipated demand, TriVascular will add 100 jobs in Santa Rosa during the next nine months, plus additional staff for a new European office in Switzerland. TriVascular currently employs 200.

The release overseas of the Ovation stent graft will most likely take place before the end of the year, bringing the 8-year-old investor-backed device maker its first revenues, said TriVascular President and CEO Michael Chobotov.

"They've been a long time coming," he said.

[caption id="attachment_19679" align="alignright" width="136" caption="TriVascular vice president of commercial operations Vivek Jayaraman will take the company's first product to market."][/caption]

Meanwhile, the company is hurrying to build a marketing and commerce operation, hiring Vivek Jayaraman, formerly vice president of global marketing for Medtronic CardioVascular, to lead the effort.

"This is a new phase for us. We've never had to think about commercialization before," said Dr. Chobotov.

The first human trials of the abdominal stent are currently under way among 30 patients in Germany, where physicians lauded its performance.

The minimally invasive treatment for aortic aneurisms can be offered to a wider range of patients than systems now on the market.

"The clinical benefits of the reduced profile and unique sealing technology were evident immediately," said the study's principal investigator, Dr. Thomas Nolte.

The product represents a significant advance over competing stent systems made by Medtronic, Cook Medical and Gore Medical, said Dr. Chobotov.

Boston Scientific, which in 2005 acquired and subsequently abandoned TriVascular and its product line, is not a competitor.

Clearance has been received for human trials of the Ovation in the U.S., which will begin shortly and run simultaneously with trials in Europe and South America, said Mr. Jayaraman.

Right on its heels will be the TriVascular thoracic stent graft system, expected to begin European trials in 2011, followed by enhancements to both systems.

"In all we'll have eight to 10 products in the pipeline," he said.

TriVascular has no plans to outsource manufacturing of the systems, although it may establish an additional manufacturing site in Europe.

Its 110,000-square-foot location on Brickway near the Charles M. Schulz-Sonoma County Airport currently has the capacity to keep up with production, although the company will eventually need to find a larger space, said Mr. Jayaraman.

Meanwhile, he has begun to hire sales and marketing staff and to set up training programs for both TriVascular employees and the physicians and staff who will be using the products.

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