St. Jude Medical CardioMEMS CM3000 User Manual

CardioMEMS
™
HF System
PA Sensor and Delivery System
Model CM2000
User's Manual

St. Jude Medical CardioMEMS CM3000 Specifications

General

Model	CM3000
Sensor Placement	Pulmonary Artery
Connectivity	Wireless
Regulatory Approvals	FDA approved
Device Type	Wireless Hemodynamic Monitoring System
Intended Use	Monitoring pulmonary artery pressure in heart failure patients
Indication	For patients with New York Heart Association (NYHA) Class III heart failure
Measurement Parameters	Pulmonary artery pressure
Data Transmission	Wireless data transmission from the implanted sensor to an external patient electronics system.
Power Source	External RF power source (during measurement)
Implant Material	Medical-grade materials
Weight (sensor)	Approximately 1 gram

Summary

Description of CardioMEMS HF System

Indications for Use

Contraindications

Clinical Considerations for Patient Selection

Warnings

Precautions

MRI Information

Potential Adverse Events

Instructions for Use

Personnel Training

Specifies that implanting physicians must complete additional training on the PA Sensor and Delivery System before implant.

System Handling and Components

Sterilization

Pre and Post Procedure Antiplatelet Regimen

Implantation Procedure

Hospital Electronics System Setup

Right Heart Catheterization and Sensor Implant Procedure

Study Endpoints

Primary Safety Endpoints

Defines the primary safety endpoints as freedom from device/system related complications and freedom from sensor failures.

Primary Efficacy Endpoint

Identifies the primary efficacy endpoint as the rate of HF hospitalizations during the first 6 months of the study.

Secondary Endpoints

Medical Management

Clinical Trial Results: Entire Randomized Access Period

Hospitalization and Mortality Outcomes

Death or All Cause Hospitalizations

Non-Serious Adverse Device Events

Adverse Device Events Summary

Unanticipated Serious Adverse Device Events

Serious Adverse Device Events