Medicare Expands Access for the Cordella PA Sensor

The Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Decision (NCD) outlining the coverage of implantable pulmonary artery pressure sensors (IPAPS) for heart failure management.

As part of that decision, the Cordella® Pulmonary Artery (PA) Sensor System is now covered under a Medicare NCD for patients with NYHA III heart failure at risk of congestive events.

Key Coverage Highlights

• Coverage Criteria: Effective immediately, IPAPS is now covered when provided according to FDA-authorized indications and when specific patient, physician, and Coverage with Evidence Development (CED) criteria are met.

• Approved Coverage with Evidence Development (CED) Study: CMS has approved the Edwards Lifesciences sponsored CED study, “The Real-World Effectiveness of The Cordella Pulmonary Artery (PA) Sensor System in Patients With Chronic Heart Failure: A Comparative Analysis to Standard of Care Pharmacologic Therapy (LOWER-PAP)” for patients with NYHA III heart failure who are at risk of congestive events. (NCT06783335)

• Other IPAPs and IDE Studies: This NCD does not affect other approved clinical trials for implantable pulmonary artery pressure sensors. The PROACTIVE-HF 2 Clinical Study continues to have CMS Category B IDE coverage for NYHA II and NYHA III patients enrolled in that study.

For reimbursement questions, contact the CordellaCares Reimbursement Helpline at 1-888-551-1579.

For important safety information, please visit endotronix.com/safety. See the Instructions for Use for a complete listing of the indications, contraindications, warnings and precautions.

References:

1. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Implantable Pulmonary Artery Pressure Sensor(s) (IPAPS) for Heart Failure Management. Effective Date: January 13, 2025
2. The Real-World Effectiveness of The Cordella Pulmonary Artery (PA) Sensor System in Patients With Chronic Heart Failure: A Comparative Analysis to Standard of Care Pharmacologic Therapy (LOWER-PAP) (NCT06783335)

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.