CVRx, Inc. engages in developing, manufacturing, and commercializing neuromodulation solutions for patients with cardiovascular diseases. It operates through the United States, Germany, and Other Countries geographical segments. The company was founded by Robert S. Kieval and Tyler P. Lipschultz in August 2001 and is headquartered in Minneapolis, MN.
Clinical Trials
23
1 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
1
4.3%
Completed
12
52.2%
Recruiting
3
13.0%
Terminated
3
13.0%
Unknown
2
8.7%
Withdrawn
2
8.7%
No approval data available
- CVRx has initiated the BENEFIT-HF clinical trial, a landmark randomized study designed to evaluate Barostim therapy in 2,500 heart failure patients across 150 centers in the U.S. and Germany. - The trial expands eligibility criteria to include patients with left ventricular ejection fraction <50% and NT-proBNP levels <5,000 pg/mL, potentially tripling the addressable patient population. - The Centers for Medicare & Medicaid Services has approved Category B IDE coverage for the trial, supporting patient access during the study period. - CVRx has also implemented new Category I CPT codes for Barostim procedures, replacing Category III codes to enable more predictable reimbursement nationwide.
• CVRx's Barostim device, designed to treat heart failure by stimulating baroreceptors, has been assigned a new payment classification by CMS, enhancing its market accessibility. • The Centers for Medicare and Medicaid Services (CMS) has classified Barostim under New Technology APC 1580, ensuring a payment of approximately $45,000, set to continue in 2025. • CMS also reassigned Barostim to a higher-paying MS-DRG for inpatient procedures, effective October 1, increasing payment from a previous range of $17,000-$23,000 to $43,000. • The American Medical Association CPT Editorial Panel approved transitioning Barostim from Category III to Category I CPT codes, expected to be implemented on January 1, 2026.
• CVRx reported that its Barostim device provides sustained improvements in heart failure patients over 24 months, enhancing their physical and psychosocial well-being. • The Barostim device, which uses baroreflex activation therapy, electrically stimulates baroreceptors to restore balance to the autonomic nervous system. • The study, published in the Journal of the American College of Cardiology: Heart Failure, builds on earlier data demonstrating long-term symptomatic benefits. • Barostim received FDA approval in 2019 for advanced heart failure and expanded its label in 2023 for broader use in heart failure patients.
• Device-based therapies are increasingly integral in managing chronic heart failure, offering solutions for structural and neurohormonal abnormalities. • The FDA's Breakthrough Device Program expedites access to innovative heart failure devices, fostering development and evaluation of these therapies. • Recent approvals and novel therapies target structural or neurohormonal issues, complementing pharmacological treatments and filling gaps in unmet needs, such as HFpEF. • Approved devices include MitraClip for mitral regurgitation, Barostim neo for autonomic modulation, and the remedē System for central sleep apnea.
