Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
Meeting on December 8, 2011, from 8 a.m. to 6 p.m. (Day 2 of 2)

Agenda: On December 8, 2011, the committee will discuss, make recommendations, and vote on information related to the PMA for the CardioMEMS HF Pressure Measurement System (HF System) sponsored by CardioMEMS, Inc. The CardioMEMS HF System is a permanently implantable pressure measurement system designed to provide daily pulmonary arterial pressure measurements including systolic, diastolic, and mean pulmonary artery pressure. These measurements are used to guide treatment of congestive heart failure. The system consists of the following:

Implantable Sensor-The Pressure Sensor is 15 millimeters (mm) in length, 3.41 mm in width and is 2 mm thick, consisting of a three dimensional coil and pressure sensitive capacitor encased between two wafers of fused silica. The coil (inductor) electromagnetically couples to the Sensor and allows the remote measurement of the resonant frequency of the LC circuit. This allows for wireless communication with the Sensor and eliminates the need for an onboard source of energy, such as a battery.

Delivery System-The Delivery System allows the placement of the Pressure Sensor within the distal pulmonary artery. There are two versions of the Delivery System. The first includes a hydrophilic coating on the distal portion of the catheter shaft and the second has no coating on the catheter shaft. Both delivery catheters have a usable length of 120 centimeters and are compatible with a 0.018" guidewire. The Delivery System (with HF Sensor) is introduced over a guide wire through an 11Fr sheath. Tether wires connect the Sensor to the Delivery System until the physician determines that the Sensor is properly positioned within the distal pulmonary artery. Once the Sensor is in position, the tether wires are withdrawn, releasing the Sensor.

Electronics Unit (Interrogator) and database-The Electronics Unit contains hardware and software to acquire and process signals from the sensor, provides a user-friendly system interface for both patients and clinicians, and transfers PA measurements to a secure database for review by medical professionals. The database is a Web-based server that contains software, which receives data transmitted from the electronics unit, and presents the data for review by medical professionals.