IRVINE, Calif., Dec. 9 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation , the world leader in heart valve technologies, announced today that the Japan Ministry of Health, Labor and Welfare (MHLW) has approved the Edwards Prima Plus stentless bioprosthesis for commercial sale in Japan.
The Edwards Prima Plus porcine tissue heart valve is designed for Japanese surgeons who prefer a stentless alternative for replacing a patient's diseased or malfunctioning aortic heart valve. Edwards' technology combines the benefits of a stentless valve with ease-of-implantation features and advanced tissue treatments designed to enhance durability. The Edwards Prima Plus heart valve has been available commercially in Europe since 1998 and the U.S. since 2001.
"This valve complements Edwards' leading tissue heart valves, providing surgeons with a range of options to fit the unique needs of each patient," said Huimin Wang, M.D., Edwards' corporate vice president and president, Japan and Intercontinental. The company expects to obtain reimbursement approval from MHLW within the next few weeks, and will begin sales in Japan immediately thereafter.
Cardiovascular disease is the leading cause of death in the world, and each year more than 300,000 people worldwide undergo open-heart surgery to treat their malfunctioning or diseased heart valves. Japanese physicians and their patients are increasingly choosing tissue heart valves which enhance quality-of-life by eliminating the requirement for anticoagulation medication, dietary restrictions and the clicking noises commonly associated with mechanical valves.
About Edwards Lifesciences
Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world and the global leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards focuses on specific cardiovascular opportunities including heart valve disease, peripheral vascular disease and critical care technologies. The company's global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, Fogarty, LifeStent, PERIMOUNT and Swan-Ganz. Additional company information can be found at http://www.edwards.com/.
Edwards Lifesciences and Edwards are trademarks of Edwards Lifesciences Corporation. Edwards Prima Plus, Carpentier-Edwards, Cosgrove-Edwards, Fogarty, PERIMOUNT and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the U.S. Patent and Trademark Office. LifeStent is a trademark of Edwards Lifesciences AG and is registered in the U.S. Patent and Trademark Office.
This news release includes forward-looking statements that involve risks and uncertainties, including those related to reimbursement approval from the Japan Ministry of Health, Labor and Welfare (MHLW), clinician acceptance of the Edwards Prima Plus heart valve; and more generally, timing or results of pending or future clinical trials, actions by the MHLW, technological advances in the medical field, product demand and market acceptance, the effect of changing economic conditions, the impact of foreign exchange, and other risks detailed in the company's filings with the Securities and Exchange Commission. These forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.
Edwards Lifesciences Corporation
The Edwards Prima Plus porcine tissue heart valve is designed for Japanese surgeons who prefer a stentless alternative for replacing a patient's diseased or malfunctioning aortic heart valve. Edwards' technology combines the benefits of a stentless valve with ease-of-implantation features and advanced tissue treatments designed to enhance durability. The Edwards Prima Plus heart valve has been available commercially in Europe since 1998 and the U.S. since 2001.
"This valve complements Edwards' leading tissue heart valves, providing surgeons with a range of options to fit the unique needs of each patient," said Huimin Wang, M.D., Edwards' corporate vice president and president, Japan and Intercontinental. The company expects to obtain reimbursement approval from MHLW within the next few weeks, and will begin sales in Japan immediately thereafter.
Cardiovascular disease is the leading cause of death in the world, and each year more than 300,000 people worldwide undergo open-heart surgery to treat their malfunctioning or diseased heart valves. Japanese physicians and their patients are increasingly choosing tissue heart valves which enhance quality-of-life by eliminating the requirement for anticoagulation medication, dietary restrictions and the clicking noises commonly associated with mechanical valves.
About Edwards Lifesciences
Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world and the global leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards focuses on specific cardiovascular opportunities including heart valve disease, peripheral vascular disease and critical care technologies. The company's global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, Fogarty, LifeStent, PERIMOUNT and Swan-Ganz. Additional company information can be found at http://www.edwards.com/.
Edwards Lifesciences and Edwards are trademarks of Edwards Lifesciences Corporation. Edwards Prima Plus, Carpentier-Edwards, Cosgrove-Edwards, Fogarty, PERIMOUNT and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the U.S. Patent and Trademark Office. LifeStent is a trademark of Edwards Lifesciences AG and is registered in the U.S. Patent and Trademark Office.
This news release includes forward-looking statements that involve risks and uncertainties, including those related to reimbursement approval from the Japan Ministry of Health, Labor and Welfare (MHLW), clinician acceptance of the Edwards Prima Plus heart valve; and more generally, timing or results of pending or future clinical trials, actions by the MHLW, technological advances in the medical field, product demand and market acceptance, the effect of changing economic conditions, the impact of foreign exchange, and other risks detailed in the company's filings with the Securities and Exchange Commission. These forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.
Edwards Lifesciences Corporation
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