Devices & Diagnostics

AGA Medical wins Chinese approval for three products

The company received Chinese regulatory approval and licenses for its AMPLATZER PFO Occluder and AMPLATZER Multi-Fenestrated Septal Occluder “Cribriform.” It also received approval, with a license pending, for its AMPLATZER Vascular Plug II. Septal occluders represent about 60 percent of company sales, while the PFO Occluder has represented about 15 percent of company sales in recent years, according to regulatory filings.

MINNEAPOLIS, Minnesota — The now publicly held AGA Medical has won Chinese approval for three of its devices and will begin selling there through its distributor, Abbott Laboratories.

A broader strategy in countries like China and India has always been part of greater expansion plans for the heart-device maker, which said as much in the prospectus it filed in June 2008. In an earnings announcement on Tuesday the company said it would use its cash to increase sales in Europe and the United States while pushing a more global effort for its cardiac plug and other devices.

It’s good news compared to the latest work out of China, when the company in the middle of last year agreed to pay a $2 million penalty to the federal government for bribery and corruption charges (pdf) related to getting Chinese officials to use AGA products.

“We see considerable opportunities in developing markets, such as China, and we are excited to expand our presence there,” John Barr, president and chief executive officer of AGA Medical, stated in a company release. AGA executives declined comment, noting they are still in their quiet period after going public last month.

The company received Chinese regulatory approval and licenses for its AMPLATZER PFO Occluder and AMPLATZER Multi-Fenestrated Septal Occluder “Cribriform.” It also received approval, with a license pending, for its AMPLATZER Vascular Plug II. Septal occluders represent about 60 percent of company sales, while the PFO Occluder has represented about 15 percent of company sales in recent years, according to regulatory filings.