BioVentrix Receives CPT Code for Surgical Left Ventricular Restoration
News related to:BioVentrix · 2 min read
BioVentrix, a medical device company focused on developing therapies to restore heart function, has received a CPT® Category III code for its surgical left ventricular restoration procedure. The code, 1132T, allows surgeons to report the use of the company's Epicardial Ventricular Anchoring System, a less invasive approach for patients with heart failure and extensive left ventricular scarring.
The procedure involves reconstructing a dilated left ventricle by excluding scarred, non-functioning heart muscle from the main pumping chamber. The aim is to restore a more normal ventricular shape and size, potentially improving the heart’s ability to pump blood. The BioVentrix Revivent System, currently under investigation in the RELIVE Trial, is designed to support this type of procedure.
The RELIVE Trial is a prospective, multi-center randomized trial comparing the Revivent System plus guideline-directed medical therapy (GDMT) with GDMT alone in patients with symptomatic heart failure and anterior/apical left ventricular scar or aneurysm. Approximately 135 patients will be randomized 2:1, with the primary safety endpoint evaluated at 30 days and the primary efficacy endpoint evaluated at one year. More information is available at ClinicalTrials.gov (NCT06813820).
The Revivent System received the CE Mark in 2016 and has received Breakthrough Device Designation from the US Food and Drug Administration. The approval of code 1132T is an important milestone for surgeons treating patients with heart failure after a large heart attack, and for the field of left ventricular restoration.
The BioVentrix Revivent System is designed to support a less invasive procedure to treat a dilated left ventricle in patients with ischemic heart failure with reduced ejection fraction (HFrEF) and extensive left ventricular scar who have a suboptimal response to guideline-directed medical therapy. The procedure uses myocardial micro-anchor implants to reconstruct the dilated left ventricle to produce a more efficient chamber. The Revivent System is currently undergoing evaluation in the RELIVE Study, a pivotal clinical trial in the United States, and is in the early stages of commercialization across Europe.
The approval of code 1132T is a significant step in establishing a standardized method for reporting the Revivent System’s use. This code supports tracking and data collection on the new procedure and can be used by payers to cover and pay for the emerging technology once it receives FDA authorization. The code 1132T is temporary and is intended to facilitate the development and evaluation of the Revivent System through the RELIVE trial.
The RELIVE trial aims to evaluate the safety and efficacy of the Revivent System in patients with symptomatic heart failure and anterior/apical left ventricular scar or aneurysm. The trial design includes a 2:1 randomization of patients to the Revivent System plus GDMT or GDMT alone. The primary safety endpoint will be evaluated at 30 days, and the primary efficacy endpoint will be evaluated at one year. The trial is expected to provide critical data to support the approval of the Revivent System for clinical use.
The BioVentrix Revivent System is a novel approach to treating heart failure, offering a less invasive alternative to traditional surgical methods. The system uses myocardial micro-anchor implants to reconstruct the dilated left ventricle, potentially improving the heart’s ability to pump blood. The approval of code 1132T is a significant milestone for BioVentrix and the medical community, as it provides a clear reporting mechanism for this innovative procedure.