Physio-Control, after three years of scrutiny, gets FDA OK for full sales

Redmond-based Physio-Control said Friday it received Food and Drug Administration (FDA) approval to resume unrestricted worldwide shipments of its external defibrillators, ending a three-year effort to convince regulators its quality-control systems are up to par.

The company, a unit of Medtronic, announced a voluntary suspension of shipments in January 2007. It signed a consent decree with the FDA in May 2008, agreeing to limit sales to emergency-service providers until improvements were completed.

The decree prevented the company from selling its automated external defibrillators (AEDs), the fast-spreading devices to treat sudden cardiac arrest that are now deployed in many airports, hotels and other public places.

The FDA restrictions also slammed the door on a planned spinoff of Physio as a separate public company. Medtronic said in December that plan was "on hold at least through the end of fiscal year 2010."

Credited with commercializing the first defibrillators 55 years ago, Physio is one of the region's oldest and largest medical-device companies.

Its shipments and profitability have been rebuilding in the past two years. Physio had sales of $192 million and pretax income of $5 million in the six months ended Oct. 24, compared with $169 million in sales and a $17 million loss in the year-earlier period, Medtronic reported.

"We dedicated significant energy and resources to establishing a new operating standard for our quality system, and we are pleased it has met with the FDA's approval," said Brian Webster, president of Physio-Control, in a statement Friday. "The quality of the products shipping from Physio-Control today is higher than it has ever been in our 55-year history. I believe the challenges we faced, and the way we met them, have made Physio-Control a stronger company for the long-term."

Spokeswoman Jennifer Roth said Physio now employs 1,100, including 750 in Redmond, nearly as many as it had before a substantial layoff in 2007.