CardioVations EndoClamp Aortic Catheter by Edwards Lifesciences recalled in US

CardioVations EndoClamp Aortic Catheter, marketed by Edwards Lifesciences has been recalled in US because of the danger of spontaneous rupture of the balloon catheters.

CardioVations EndoClamp Aortic Catheter Model Numbers EC1001 and EC65 have been issued class 1 recall alert by US FDA.

CardioVations EndoClamp Aortic Catheter uses a device that blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures.

US FDA initiated the recall of CardioVations EndoClamp Aortic Catheter because the balloon catheters may spontaneously rupture during surgery.

CardioVations EndoClamp Aortic Catheter Model Numbers EC1001 and EC65 were manufactured from August, 2008 through August, 2009 and distributed from November, 2008 through September, 2009,  US FDA and Edwards Lifesciences notified healthcare professionals.

The EndoClamp catheter is indicated for use in patients undergoing cardiopulmonary bypass. The EndoClamp catheter occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.

Edwards Lifesciences is the global leader in heart valves and hemodynamic monitoring, with more than five decades of experience in partnering with clinicians to develop life-saving innovations. Headquartered in Irvine, Calif., Edwards treats advanced cardiovascular disease with its market-leading heart valve therapies, and critical care and vascular technologies, which are sold in approximately 100 countries. The company’s global brands include Carpentier-Edwards, Cosgrove-Edwards, Edwards SAPIEN, FloTrac, Fogarty, PERIMOUNT Magna and Swan-Ganz.

Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced today that in anticipation of future growth, the company will beas recently started developing a new state-of-the-art manufacturing facility in Draper, Utah, which will enable it to significantly expand its manufacturing and R&D capability.

Edwards has accepted incentives from the State of Utah totaling approximately $11.5 million based on the current 228 jobs being retained and more than 1,000 projected new jobs in manufacturing, business and engineering expected to be created in the state during the life of the 15-year incentive period. The company also accepted an incentive from the City of Draper for approximately $3 million based on capital investments and employment rates over a seven-year incentive period.

As the first step of its planned expansion, the company will transfer manufacturing of its market-leading cannula and embolic protection devices utilized by cardiac surgeons during open-heart surgery from its existing Midvale, Utah facility to the new facility in Draper in the first half of 2010.