FDA green lights Coviden’s surgical device

BOULDER – The FDA has given Covidien plc the green light to sell its LigaSure Maryland jaw surgical device that is being developed in Boulder.

The LigaSure Maryland surgical device seals openings in a patient’s body that a surgeon makes during minimally invasive surgery.

While LigaSure devices have been used by surgeons for the last 15 years, the new product can reduce blood loss, shorten procedure time and shorten the length of a patient’s hospital stay, said Chris Barry, president of the advanced surgical unit of Covidien.

Covidien announced that the device had received FDA approval on Wednesday. The FDA must approve all drugs and medical devices sold in the United States, a process that often takes years.

Covidien plans to start selling the new product in the United States and in the European Union during the current quarter, according to a press statement. Previous LigaSure technology has been used in more than 8 million sealing procedures around the globe, according to the press statement.

The device comes in three lengths – 23 centimeters (9 inches), 37 centimeters(14.5 inches) and 44 centimeters (17.3 inches). It’s used in gynecologic, thoracoscopic, urologic and vascular surgeries. Pricing details for the device were not immediately available.

The company has 1,800 employees at the plant in Gunbarrel, with about 1,400 working in the surgical solutions division and 400 working in the respiratory and monitoring devices division. The company does not anticipate adding more jobs because of the FDA approval. In all, the company has about 38,000 employees working in more than 70 countries.


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