Edwards Lifesciences Corp was incorporated in Delaware on September 10, 1999. The Company is the manufacturer of heart valves and repair products used to replace or repair a patient's diseased or defective heart valve. It is also a global leader in hemodynamic monitoring systems used to measure a patient's cardiovascular function in the hospital setting. It conducts operations worldwide and are managed in the following geographical regions: United States, Europe, Japan and Rest of World. The products and technologies provided by the Company to treat advanced cardiovascular disease or critically ill patients are categorized into the following main areas: Surgical Heart Valve Therapy, Transcatheter Heart Valves, and Critical Care. The Company's Surgical Heart Valve Therapy portfolio includes tissue heart valves and heart valve repair products for the surgical replacement or repair of a patient's heart valve. The portfolio also includes a diverse line of cardiac surgery systems used during minimally invasive surgical procedures, and cannulae, embolic protection devices and other products used during cardiopulmonary bypass. The Company's Transcatheter Heart Valves portfolio includes technologies designed to treat heart valve disease using catheter-based approaches as opposed to open surgical techniques. In the Critical Care portfolio, Edwards Lifesciences' products include pulmonary artery catheters, disposable pressure transducers and advanced monitoring systems. The portfolio also includes a line of balloon catheter-based vascular products, surgical clips and inserts. The Company competes with many companies, including divisions of companies much larger than it and smaller companies that compete in specific product lines or certain geographies. The Company's Surgical Heart Valve Therapy and Transcatheter Heart Valve products are manufactured in California and Utah in the United States, Switzerland, and Singapore. Critical Care products are manufactured primarily in its facilities located in Puerto Rico and the Dominican Republic. The Company's products and technologies are subject to regulation by numerous domestic and foreign government agencies, including the FDA, and various laws and regulations governing the development, testing, manufacturing, labeling, marketing and distribution of its products and technologies.