Get Engaged
Manage your Heart Failure from Home with Cordella®
What is heart failure and how is it treated?
Heart Failure is a medical condition where the heart is unable to pump enough oxygen-rich blood to the rest of the body. When the heart muscle is unable to produce enough energy to pump blood to the rest of the body, the parts of the body farthest away from the heart will be the first to be deprived of oxygen and nutrient-blood needed to properly function.
More severe heart failure* leads to symptoms such as shortness of breath, fatigue, and swelling of the feet and ankles. If left untreated, heart failure can severely impact a person’s activity level and ultimately quality of life. However, people with heart failure can lead a full and enjoyable life when the condition is proactively managed with healthy lifestyle, medication, or surgical intervention.
Why is Pulmonary Artery (PA) Pressure important to managing my heart failure?
Changes in PA pressure often indicate worsening heart failure before an urgent intervention is required.1
Why are changes in blood pressure and weight important to managing my heart failure?
If not properly managed on an ongoing basis your heart failure can worsen, resulting in hospitalization and potential surgical intervention. Similar to car maintenance, it is important to monitor and manage your heart failure before problems arise. By monitoring key health metrics like blood pressure, and weight you and your doctor can take a proactive approach to your health.
*New York Heart Association (NYHA) class III
Hear Tom’s Story
Living with Heart Failure with help from Cordella
What is the PROACTIVE-HF 2 Trial?
The PROACTIVE-HF 2 trial is designed to evaluate how pulmonary artery (PA) pressure and additional vital sign data, securely collected with Cordella, can help you better manage your heart failure from home under the guidance of a clinician*. The trial is intended to assess the benefits of remote PA pressure management in NYHA class II and III heart failure patients.
*Includes vital sign data for blood pressure, heart rate, oxygen levels and weight.
Who is eligible to participate?
- You have been diagnosed with NYHA Class II or Class III heart failure.
- You have had a recent HF hospitalization, HF treatment in a hospital day-care setting, or urgent outpatient clinical HF visit for IV diuretics.
The clinical staff will review your medical history, your current health status, and ensure you meet all the trial’s enrollment criteria. If you are eligible, they will review the study risks and benefits to address any questions you may have. This process is referred to as informed consent.
Meet Cordella™
Proactive Comprehensive Engaging
Cordella™ PA Sensor System†
Wireless, implantable sensor for remote transmission of pulmonary artery (PA) pressures
myCordella™ Patient Kit
At-home kit collects and securely transmits health data to the clinician
95%
of patients want to see their health information2
97%
of patients said the Cordella is easy to use3
97%
of patients believe PA pressure monitoring with Cordella & resulting care has a positive health impact2
Cordella in the News
Watch how physicians use Cordella to help guide therapy for patients suffering from heart failure.
Backed by Clinical Data
Positive results from a clinical trial on the Cordella Sensor were recently published4 and further support the growing clinical evidence for using PA pressure-guided management to treat heart failure.
As with any medical procedure, there is a possibility of risks. The most serious risks of the Cordella PA Sensor procedure are similar to other heart procedures and include death, serious damage to the arteries, serious bleeding, breathing problems, renal (kidney issues) and worsening heart failure.
Don’t Take Heart Failure Lying Down
The comprehensive platform enables regular review of key health metrics to help guide your medical management from home.
- Proactive care with medication adjustments
- Comprehensive daily health status
- Engage with your health data
- Connect with your care team
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.
For important risk information, please visit myheart.com/risks. See the instructions for use for a complete listing of listing of the indications, contraindications, warnings and precautions.
For more information, please visit clinicaltrials.gov (NCT05934487).
† The Cordella PA Pressure Sensor System is an investigational device in NYHA Class II patients and is not currently approved for clinical use in NYHA Class II patients in any geography, nor has it been proven safe or effective in NYHA Class II HF patients. CAUTION – Investigational Device. Limited by Federal (or United States) Law to Investigational Use. Exclusively for Clinical Investigation
- Heidenreich PA et al. Circulation. 2022;145:e895-e132.
- Heidenreich PA, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;145:e895-e1032. doi: 10.1161/CIR.0000000000001063.
- Sharif F et al. ESC Heart Fail. 2024 Apr; 11(2):1133-1143.
- Guichard JL et al. J Am Coll Cardiol HF. 2024 Aug 2:S2213-1779(24)00485-2.
In the U.S., the Cordella PA Sensor System is Rx Only. CAUTION: Federal law restricts this device to sale by or on the order of a physician.
In Europe, the Cordella PA Sensor System is Exclusively for Clinical Investigation.