Press Releases August 24, 2026 08:30 AM

CVRx Announces Devoted Health Medicare Advantage Coverage Policy for Barostim Therapy

Devoted Health issues Medicare Advantage coverage policy for CVRx's Barostim therapy, expanding patient access.

By Avery Klein
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CVRX

CVRx, Inc. announced that Devoted Health, a major Medicare Advantage insurer, has established a coverage policy for its Barostim therapy, effective July 2026. This policy complements existing coverage from Humana and CMS approvals, covering a significant portion of Medicare Advantage members and supporting broader patient access to this FDA-approved neuromodulation treatment for heart failure.

CVRx Announces Devoted Health Medicare Advantage Coverage Policy for Barostim Therapy
CVRX
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Key Points

  • Devoted Health's coverage policy increases Medicare Advantage access to Barostim therapy for heart failure patients, reaching approximately 466,000 members.
  • Barostim is an FDA-approved neuromodulation device for heart failure with recent CPT coding and CMS IDE coverage support, enhancing reimbursement prospects.
  • The new policy supports patients enrolled in the BENEFIT-HF trial, expanding coverage to a broader population and signaling potential growth in clinical adoption.

MINNEAPOLIS, Aug. 24, 2026 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, announced today that Devoted Health has issued a Medicare Advantage coverage policy for Barostim therapy, effective July 17, 2026. Devoted Health, a national health insurance company with the eighth largest Medicare Advantage enrollment in the U.S., provides coverage to approximately 466,000 Medicare Advantage members across 29 states.

The new policy covers Barostim for patients meeting its current FDA-approved indication as well as patients enrolled in the BENEFIT-HF trial, the landmark heart failure study evaluating Barostim in a significantly expanded patient population initiated earlier this year.

“We are pleased that Devoted Health, one of the fastest-growing Medicare Advantage plans in the U.S., has issued a policy covering Barostim,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “Together, the Devoted Health and Humana coverage policies represent approximately 21 percent of Medicare Advantage enrollment and mark continued progress toward broader, more consistent coverage for Barostim and greater access to the therapy for patients living with heart failure.”

The Devoted Health policy builds on several other positive reimbursement developments for Barostim in 2026. In January, Category I CPT codes went into effect for the Barostim procedure, and the Centers for Medicare & Medicaid Services (CMS) approved Category B IDE coverage for patients enrolled in the BENEFIT-HF trial. In May, Humana issued a Barostim therapy coverage policy for Medicare Advantage members and patients enrolled in the BENEFIT-HF trial.

About CVRx, Inc.
CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. 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 been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com.

Investor Contact:
Mark Klausner or Mike Vallie
ICR Healthcare
443-213-0501
[email protected]

Media Contact:
Emily Meyers
CVRx, Inc.
763-416-2853
[email protected]


Risks

  • Dependence on reimbursement policies: Although coverage is expanding, future changes in Medicare Advantage plans or CMS policies could affect therapy adoption and revenue.
  • Clinical trial outcomes risk: The BENEFIT-HF trial results will influence long-term coverage and market penetration; negative or inconclusive outcomes may hinder growth.
  • Market competition and technological innovation risk: Advances by competitors in heart failure treatment or neuromodulation could reduce Barostim's market share or patient preference.

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