This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: OPTIMIZER Smart System
PMA Applicant: Impulse Dynamics (USA), Inc.
Address: 30 Ramland Rd, Suite 204, Orangeburg, NY 10962
Approval Date: March 21, 2019
Approval Letter: Approval Order

What is it?
The OPTIMIZER Smart System includes an implantable pulse generator (IPG), a charging system and a programmer. The IPG monitors the heart’s activity and delivers non-excitatory electrical signals (cardiac contractility modulation therapy) to the right ventricle of the heart in patients with chronic heart failure.

The charging system is used to recharge the IPG and the programmer to allows medical personnel to control the settings of the device.

How does it work?
The OPTIMIZER Smart IPG is implanted under the skin in the upper left or right area of the chest and connected to electrodes that attach to the heart. After implant, a doctor tests and programs the device based on the patient’s individual requirements. The OPTIMIZER SMART IPG monitors the heart’s activity and delivers cardiac contractility modulation (CCM) therapy when the heart tissue is not capable of activation (myocardial absolute refactory period). As a result, CCM signals are non-excitatory and have no pacemaker or implantable defibrillator function. Instead, CCM signals triggers activities in heart muscle cells and improves cardiac performance.

When is it used?
The OPTIMIZER Smart System is intended to be used in patients 18 years or older who have moderate to severe symptoms of heart failure and are not responding to medical therapy.

What will it accomplish?
The OPTIMIZER SMART System may improve an individual's ability to perform normal daily activities, distance walked, and quality of life.

When should it not be used?
The OPTIMIZER Smart System should not be used in patients with:

• A permanent or long-standing persistent abnormal heart rhythm (atrial fibrillation) or flutter
• A tricuspid valve made of man-made materials, such as metal, stainless steel, titanium, or ceramic
• An inability to obtain vascular access for implantation of the electrodes

Additional information (including warnings, precautions, and adverse events): 

• Summary of Safety and Effectiveness Data (SSED)
• Patient Labeling: Patient’s Manual
• Physician Labeling: Instructions for Use
• PMA Database Entry