Full Press Release Details
MINNEAPOLIS, Oct. 18, 2024 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, announced today that the American Medical Association (AMA) CPT® Editorial Panel has accepted new Current Procedural Terminology (CPT) Category I codes for baroreflex activation therapy (“Barostim”) to treat the symptoms of heart failure.
In response to the increased utilization of Barostim therapy and the strong evidence supporting its clinical outcomes, the AMA CPT Editorial Panel accepted the application for Category I CPT codes. This decision will help further facilitate reimbursement for healthcare providers performing the Barostim procedure and enable broader patient access. This effort was led by the Society for Vascular Surgery (SVS) and supported by the American College of Cardiology (ACC) and others. These codes are expected to be implemented on January 1, 2026. In the interim, U.S. hospitals and physicians performing Barostim procedures should continue to utilize the existing Category III codes.
“We are very pleased that the AMA’s CPT Editorial Panel approved the conversion to Category I codes,” said Kevin Hykes, CEO of CVRx. “The Category I code designation represents an important milestone for the company and is a testament to the increased adoption, safety, and effectiveness of Barostim as an important option for patients suffering from the debilitating symptoms of heart failure. We greatly appreciate the support and guidance that SVS and ACC provided throughout this process.”
CVRx is focused on the development and commercialization of the Barostim™ System, the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. Baroreceptors activate the body’s baroreflex, which in turn triggers an autonomic response to the heart. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements about expected implementation of the Category I CPT code and further facilitation of reimbursement and patient access are forward-looking statements. These statements speak only as of the date of this press release and are based on our current expectations and projections about future events, and are subject to a number of known and unknown risks and uncertainties that could cause actual results to differ from our expectations, including completion of a formal survey to be conducted by AMA to determine the reimbursement level and the actual impact of the codes on actual reimbursement and patient access. These forward-looking statements speak only as of the date of this press release. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Mark Klausner or Mike Vallie