The market for cardiac assist and heart replacement technology is emerging. Our BVS 5000 Bi-ventricular Support System is the most widely used device for supplying full circulatory assistance for the treatment of patients with failing but recoverable hearts. Underlying the BVS 5000 and AbioCor is enabling technology for other market opportunities. We continue to invest in enhancements, improvements and expansion opportunities to the BVS 5000 product line while investing significantly towards introducing the AbioCor and other new product opportunities.
Heart failure is the number one cause of death worldwide.
End-stage heart failure patients today have few alternatives. We believe that the need for an implantable replacement heart may exceed 100,000 patients annually in the U.S. alone. In the European Union, the BVS 5000 is ISO 9001 and CE Certified. It is also in leading medical centers around the globe and has supported the lives of thousands of patients. These revenues are split between sales of the full system to new customers and replacement sales of single-use blood pumps and related disposable items to existing customers.