CVRx Announces First Clinical Procedure with a New Ultrasound-Guided Implant Approach, the Latest Advancement in Barostim™ for the Treatment of Heart Failure Symptoms
MINNEAPOLIS, June 10, 2021 - CVRx©. developer of the world`s first FDA-approved neuromodulation device to treat the symptoms of heart failure (HF). announced the completion of the first clinical procedure with the company`s new lead implantation approach. The novel ultrasound-guided technique is the latest advancement of
CVRx`s Barostim™ Baroreflex Activation Therapy (BAT™) to treat the symptoms of HF patients. The new approach further simplifies the implant procedure by using minimally invasive techniques and ultrasound imaging to guide the placement of a small stimulation lead near the targeted carotid baroreceptors.
The procedure was performed by cardiac electrophysiologist James D. Allred. M.D. and vascular surgeon Wells Brabham, M.D.. at The Moses H. Cone Memorial Hospital in Greensboro, North Carolina. Commenting on the technology. Dr. Allred said, "This new approach to treatment represents a potentially game-changing advancement in the way we manage patients with HF symptoms. We are excited to participate in this study evaluating the ultrasound-guided approach as a new implant technique to deliver this therapy"
"We are pleased to have participated in this first-in-human procedure at our center," said Dr. Brabham. "We are excited by this new approach and we are happy to contribute towards the investigation of a new way to deliver this important therapy to patients."
"Congratulations to Drs. Allred and Brabham and Moses Cone Hospital on successfully completing this first clinical procedure in the study of this new implant technique," said NadimYared. President and CEO of CVRx. "We value our collaboration with them and commend their ongoing efforts to advance neuromodulation to treat HF symptoms."
Barostim is now commercially available to reduce the symptoms of HF for patients who are not indicated for CRT and have a left ventricular ejection fraction of 35% or less. Barostim is also the recipient of the Centers for Medicare and Medicaid Services (CMS) outpatient Transitional Pass-Through Payment Status (TPT) and inpatient New Technology Add-On Payment (NTAP).
About Heart Failure
Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood to meet the body`s needs for blood and oxygen. In the US. heart failure is estimated to affect 6.9 million adults and is expected to increase by 24% to nearly 8.5 million in 2030. Overall, heart failure is associated with a four-fold increased risk of death and a six to nine times increased risk of sudden cardiac death. Despite current standard of care, the clinical burden remains high. In the US. the total direct and indirect costs of care for HF is estimated at S43.6 billion, with over 70% of costs attributed to medical costs. Without improvements in outcomes, the annual total cost of care in the USA is projected to increase to S69.7 billion by 2030.