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: CardioMEMS HF System
PMA Applicant: CardioMEMS, Inc.
Address: 387 Technology Circle, NW, STE 500, Atlanta, GA 30313
Approval Date: May 28, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100045a.pdf
What is it? The CardioMEMS HF System measures and monitors the pulmonary artery (PA) pressure and heart rate in certain heart failure patients. The System consists of an implantable PA sensor, delivery system, and Patient Electronics System. The implantable sensor is permanently placed in the pulmonary artery, the blood vessel that moves blood from the heart to the lungs. The sensor is implanted during a right heart catheterization procedure. The PA sensor is about the size of small paper clip and has a thin, curved wire at each end. This sensor does not require any batteries or wires.
The delivery system is a long, thin, flexible tube (catheter) that moves through the blood vessels and is designed to release the implantable sensor in the far end of the pulmonary artery.
The Patient Electronics System includes the electronics unit, antenna and pillow. Together, the components of the Patient Electronics System read the PA pressure measurements from the sensor wirelessly and then transmit the information to the doctor. The antenna is paddle-shaped and is pre-assembled inside a pillow to make it easier and more comfortable for the patient to take readings.
How does it work? The sensor monitors the pressure in the pulmonary artery. Patients take a daily reading from home or other non-clinical locations using the Patient Electronics System which sends the information to the doctor. After analyzing the information, the doctor may make medication changes to help treat the patient’s heart failure.
When is it used? The CardioMEMS HF System is used to wirelessly measure and monitor PA pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. The PA pressure and heart rate are used by doctors for heart failure management and with the goal of reducing heart failure hospitalizations.
The CardioMEMS HF System is used by the doctor in the hospital or medical office setting to obtain and review PA pressure measurements. The patient uses the CardioMEMS HF System at home or other non-clinical locations to wirelessly obtain and send PA pressure and heart rate measurements to a secure database for review and evaluation by the patient’s doctor.
What will it accomplish? Access to PA pressure data provides doctors with another way to better manage a patient’s heart failure and potentially reduce heart failure-related hospitalizations. Reducing heart failure hospitalizations has a direct impact on a patient’s well-being. In a clinical study in which 550 participants had the device implanted, there was a clinically and statistically significant reduction in heart failure-related hospitalizations for the participants whose doctors had access to PA pressure data. Additionally, there were no device or system-related complications or pressure sensor failures through six months.
When should it not be used? The CardioMEMS HF System is contraindicated for those patients who are unable to take two types of blood thinning medicines for one month after the sensor is implanted.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.