New surgical medical devices coming online

BOULDER — Boulder County is home to a medical-device industry that employs thousands of people.
The county has about a half dozen medical device companies employing 3,176 people, one of the highest concentrations in the state, according to state statistics.

Covidien Plc. (NYSE: COV) is the biggest player — developing and making electrosurgery devices at its research and development facility and a manufacturing plant in Boulder. Covidien’s LigaSure Maryland Jaw surgical device created in Boulder recently was approved by the U.S. Food and Drug Administration. The device seals openings in a patient’s body that a surgeon makes during minimally invasive procedures.

About 1,400 people work in the surgical solutions unit of Covidien in Boulder, making it one of the largest employers in the county. Covidien plans to start selling the new product in the United States and in the European Union during the current quarter. Previous LigaSure technology has been used in more than 8 million sealing procedures around the globe.

Companies such as Encision Inc. (ECIA: PK) in Boulder, which makes a device to protect patients from burns during minimally invasive surgery, were started by former employees of Valleylab, the predecessor company to Covidien.

Encision’s AEM Endoshield device may receive FDA approval this spring, said Greg Trudel, the company’s chief executive. The patented device’s name stands for active electrode monitoring. FDA approval is required for all medical device products sold in the United States.

Burn danger has been a big issue for surgeons who use energy devices during surgery, Trudel said. Burns often go unnoticed during surgeries, but if left untreated can cause major complications including death, Trudel said.

“The Colorado environment is a great place for the medical-device industry,” Trudel said. “The technology is here, and there’s a great labor force of highly skilled people.”

Biomet Inc.’s spinal device division in Broomfield is well-regarded in the medical-device industry. The former Lanx Inc., started by a group of investors and physicians in 2003, was sold for $147 million in October to Biomet in Warsaw, Indiana. The spinal device office has about 200 workers who make products for patients with degenerative disk disease.

BioMet’s testing lab at its 80,000-square-foot facility at 310 Interlocken Parkway, Suite 120, is accredited by the U.S. Food and Drug Administration.

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