Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System

Stopped The primary objective of the protocol was to allow ongoing access to treatment of patients suffering from moderate to severe heart failure at selected investigational sites until the PMA was approved by the FDA for the OPTIMIZER System.

Conditions

• Heart Failure
• Congestive Heart Failure
• Chronic Heart Disease
• CHF

Interventions

• DEVICE: Optimizer Smart System

Sponsor

Impulse Dynamics