Medical Device Daily Executive Editor

Edwards Lifesciences (Irvine, California) yesterday reported that the FDA has notified it that the company's response to the agency's February 2007 warning letter "adequately addresses" the agency's concerns, and that the agency will not defer approval of pending pre-market submissions or export certificates for products manufactured at the company's Irvine facility.

The warning letter was issued to Edwards in February (Medical Device Daily, Feb. 13, 2007), saying that the company could not receive premarket approvals for devices until it resolved issues raised in the letter, primarily quality systems, quality systems training, documentation and complaint handling at the company's Irvine facility. The warning reportedly stemmed from an inspection completed last August.

At the time, the company said that the warning letter would have no "financial impact" on its results.

Edwards this week in its quarterly earnings report revised its financial guidance, but a company spokesperson told Medical Device Daily that the change had no relationship to the FDA letter.

The revised 2007 sales guidance is for between $1.070 billion and $1.110 billion, primarily as a result of the recent divestiture of its TMR product line to Novadaq Technologies (Toronto) (MDD, March 22, 2007), for somewhat more than $8 million, including what it called "minor adjustments in Critical Care and Heart Valve Therapy sales guidance." Its previous guidance was for 2007 sales between $1.075 to $1.125 billion.

Following receipt of the warning letter, Edwards said it engaged "independent, external resources to assist in implementing best-in-class quality systems." The spokesperson also noted that it had met with the FDA in March to resolve the issues in the warning letter.

Michael Mussallem, CEO and chairman of Edwards, in the company's statement yesterday said, "We have been very focused on promptly resolving the issues identified in the warning letter, and are pleased with the FDA's conclusion. As a company dedicated to improving the lives of patients by developing high-quality cardiovascular technologies, we are committed to the continual improvement of our quality systems and investing to make those systems best-in-class."

Edwards bills itself as the No. 1 heart valve company in the world and the global leader in acute hemodynamic monitoring. The company's global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, LifeStent, PERIMOUNT Magna, and Swan-Ganz.