BVS 5000

• >500 U. S. Centers
• >85% Adult Cardiac Transplant Centers
• >85% of all Cardiac Surgery Teaching Institutions
• >6,000 Patients Supported
• >350 BVS Patients Transported (via the ABIOMED HUB & SPOKE PROGRAM)

BVS 5000 - FDA Approved Indications for Use
The BVS 5000 indications for use encompass any cardiac disorder, resulting in ventricular failure, where BVS assist is likely to allow native heart recovery. This includes, but is not limited to: postcardiotomy shock, failed cardiac transplant, right heart failure while on an implantable left ventricular assist device, and other cardiac conditions such as viral myocarditis.

FACT:
The hospital mortality for patients successfully separating from CPB on no inotropes, low-dose, moderate-dose, one high-dose, two high-dose, and three high-dose inotropes were approximately 2.0%, 3.0%, 7.5%, 21%, 42%, and 80% respectively. Samuels LE, et al. Pharmacological Criteria for ventricular assist device insertion following postcardiotomy shock: experience with the ABIOMED BVS system. J Card Surg 1999; 14:288-93

Experienced centers, with well defined protocols for patient selection and timing of intervention, report BVS survival approaching 50% in the postcardiotomy setting.

Emerging use of the BVS in the AMI-cardiogenic shock indication increased to 18% in 2000.

BVS 5000 - Utilization (cumulative data from ABIOMED Voluntary Worldwide Registry):

• 63% - Postcardiotomy
• 9% - AMI Cardiogenic Shock
• 2% - Myocarditis
• 8% - Failed Cardiac Transplant
• 18% - Other