EBR Systems nears FDA approval for CRT pacemaker

4 Views

  • Thanks! Share it with your friends!

    You disliked this video. Thanks for the feedback!

admin
Published
EBR Systems Inc. Senior Vice President Andrew Shute talked with Proactive at the ASX SMIDcaps Conference about the company’s upcoming FDA decision for its leadless CRT pacemaker system. The device is designed to treat heart failure and represents the only leadless option in a market currently dominated by three players—with no direct competitor.

Shute said, “We've developed the world's only leadless pacemaker to treat heart failure. And we're on track to receive FDA approval within the next two and a half weeks.” The product already holds FDA Breakthrough Device designation, and has shown strong clinical results, including a 16.4% reduction in left ventricular end systolic volume—well above the target goal of 9.3%.

Shute outlined the company's go-to-market plan, emphasising that reimbursement is expected to begin from October 1st under the NTAP and TPT schemes, enabling an ASP of USD 45,000. The company only needs to sell around 2,200 units annually to reach USD 100 million in revenue. “We’ve got no direct competition,” he said.

He also highlighted the successful completion of the FDA’s pre-approval inspection with no observations—an uncommon achievement in the medical device industry.

The device, supported by data published in JAMA Cardiology, was also featured at the Heart Rhythm Society meeting in 2023. During the interim, the US commercial team will establish purchasing agreements, prepare technology committee engagements, and begin physician training for a limited market release.

#EBRSystems #MedicalDevices #HeartFailureTreatment #LeadlessPacemaker #CardiacTech #FDAApproval #CRTDevice #InvestingInHealthcare #BreakthroughDevice #MedTechInnovation #JAMACardiology #HeartRhythmSociety
Category
Cardiology
Be the first to comment

Up Next