Important Risk Information
Cordella Pulmonary Artery Sensor

Intended Use: The Cordella Pulmonary Artery Sensor is designed to measure and send pulmonary artery pressure (PAP) data for patients with Class III heart failure who are receiving medical treatment and have been stable for 30 days.

Who should not receive the device (Contraindications): Do not use the Cordella Sensor in patients who cannot take blood thinners for at least one month after the implant.

Important Safety Considerations: The Reader and Calibration Equipment should be kept away from sources of electromagnetic interference, such as certain medical equipment or portable RF devices, to avoid affecting readings, and there should be no metal objects, jewelry, or electronic devices near the Reader during a reading. Changes in altitude above 2,000 meters may affect measurement accuracy, so consult your healthcare provider if you plan to travel or move to higher elevations; activities like SCUBA diving could also impact device performance. Follow prescribed blood thinners and other medications as directed after the implant, and avoid exposing the Cordella Sensor to therapeutic ultrasonic energy.

Complications and Side Effects: The risks associated with the Cordella Pulmonary Artery Sensor are similar to other heart procedures and include: allergic reactions, heart rhythm problems (arrhythmias), bleeding, device movement or failure , infection or fever, breathing problems or lung issues, blood clots in the lungs (pulmonary embolism), vascular damage that may need surgery, renal (kidney) issues, worsening heart failure, and death.
This is not a full list of all the risks that could occur with the Cordella Pulmonary Artery Sensor. Talk to your doctor for more information about these and other potential risks. This information is not meant to replace talking with your doctor.