ºù«ÍÞÊÓƵ's Cardiac Rhythm Management (CRM) business delivered noteworthy 10% sales growth in the second quarter, driven by accelerating adoption of our AVEIRâ„¢ leadless pacemaker (LP) systems. Following the earlier success of our single chamber ventricular (VR) device, FDA approval of the along with the atrial (AR) device in 2023 marked a turning point for our CRM business—and the 80% of pacemaker users who need pacing in two chambers of the heart to treat slow or abnormal heart rhythms.
Unlike traditional pacemakers, leadless pacemakers are implanted directly into the heart through a minimally invasive catheter-based procedure and eliminate the need for cardiac leads. That means fewer lead-related complications and a less restrictive recovery. ºù«ÍÞÊÓƵ's AVEIR pacemaker is smaller than a AAA battery, and once implanted it is not visible to the eye and leaves no scar.Ìý
Revolutionizing a $7B+ Market
With 12.1 million2 people in the U.S. projected to have cardiac arrhythmias by 2030, and the global pacemaker market expected to exceed $7 billion3, ºù«ÍÞÊÓƵ's AVEIR portfolio is revolutionizing care for patients and capturing share in the fast-growing leadless segment. Our CRM business previously posted single-digit growth, and now thanks to accelerating uptake of AVEIR, we've achieved a double-digit growth rate that we believe is sustainable.1
The AVEIR portfolio lets physicians tailor therapy based on patients' needs—the single chamber AR and VR devices can be implanted individually or used together to provide the world's first dual chamber LP system. ºù«ÍÞÊÓƵ is the only company that offers atrial leadless pacing. The combination of those two devices in the AVEIR DR LP is an engineering marvel and truly life-changing for people who need dual chamber pacemakers.
Transformational Technology
Prior to ºù«ÍÞÊÓƵ's 2023 launch of AVEIR AR and DR LPs, leadless pacing options were limited to only ventricular devices. No atrial LP device had been approved, and seamless synchronization of two leadless pacemakers posed a significant technological hurdle. But AVEIR DR LPs solved that challenge with first-of-its-kind atrial implant as well as implant-to-implant (i2iâ„¢) technology to provide synchronized pacing and beat-to-beat communication between co-implanted devices—one to pace the right atrium and the other to pace the right ventricle.
Never before has it been possible to implant two leadless devices in the upper and lower chambers of the heart that can communicate with each other to allow the heart to beat in synchrony—and the medical community has taken notice. Between Q2 2024 and Q2 2025, the number of physicians trained on AVEIR DR LPs and the number of daily implants both doubled.1
"… We took our time to do this and do this right," CEO Robert Ford said of the AVEIR rollout on ºù«ÍÞÊÓƵ's second-quarter earnings call. "And I think we're seeing the benefits here of taking that time to do it right. I think it's really driving uptake, not just in single, but without a doubt, in dual chamber."
Continued innovation will fuel ºù«ÍÞÊÓƵ's momentum in the pacemaker market. AVEIR is now available in 50 countries, with continued international rollout underway. We're also launching a next-generation atrial device with 25% longer battery life. Following the success of our investigational —the world's first evaluation of a leadless pacemaker delivering physiologic pacing that closely mimics the heart's natural rhythm—we plan to begin the pivotal trial next year.
"So, I think there's a lot of good momentum here with this portfolio, not just in terms of execution out in the market, but also in terms of R&D and clinical work," Ford said.
The Human Impact
Cardiologists from leading hospitals are eager to offer their patients AVEIR DR LPs. Their real-time mapping capability helps physicians place the devices accurately, and the helix design allows for removal in the future. These features are designed to offer tools for physicians to achieve improved patient outcomes.
"We are in a landmark moment for the CRM field. For the first time, we have a dual chamber leadless pacemaker—both chambers of the heart can be connected without using wires," said Cyrus Hadadi, M.D., associate director of cardiac arrhythmia research at MedStar Health. "When I started practicing medicine, we thought this was impossible, and today we have FDA approval on AVEIR DR [LP system]."
As more physicians adopt AVEIR DR LPs, more people are getting the chance to live life to the fullest—including professional surfer Mikey DeTemple. Diagnosed with third-degree heart block at age 11, DeTemple relied for decades on traditional pacemakers, which often kept him out of the water with physical limitations and occasionally in the hospital with lead failures. Now thanks to implantation with the AVEIR DR LP system, DeTemple has the energy and freedom to ride the waves—without any wires or visible reminders of his condition holding him back.
"I have no limitations," DeTemple said.
References
1 2Q25 earnings call transcript
2
3
IMPORTANT SAFETY INFORMATION
AVEIRâ„¢ DR
Rx Only
Brief Summary:ÌýPrior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications:ÌýThe Aveirâ„¢ Leadless Pacemaker system is indicated for management of one or more of the following permanent conditions: Syncope, Pre-syncope, Fatigue, Disorientation. Rate-modulated pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-chamber pacing is indicated for patients exhibiting: Sick sinus syndrome, Chronic, symptomatic second- and third-degree AV block, Recurrent Adams-Stokes syndrome, Symptomatic bilateral bundle-branch block when tachyarrhythmia and other causes have been ruled out. Atrial pacing is indicated for patients with: Sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular pacing is indicated for patients with: Significant bradycardia and normal sinus rhythm with only rare episodes of AV block or sinus arrest, Chronic atrial fibrillation, Severe physical disability.
Intended Use:ÌýThe Aveirâ„¢ Leadless Pacemaker (LP) is designed to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation in the right ventricle and/or right atrium. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy within the implanted chamber for the target treatment group. The LP is also intended to operate optionally with another co-implanted LP to provide dual-chamber pacing therapy.
The Aveirâ„¢ Delivery Catheter is intended to be used in the peripheral vasculature and the cardiovascular system to deliver and manipulate an LP. Delivery and manipulation includes implanting an LP within the target chamber of the heart.
Contraindications:ÌýUse of the Aveirâ„¢ Leadless Pacemaker is contraindicated in these cases:
Ìý
Adverse Events:ÌýPotential complications associated with the use of the Aveirâ„¢ Leadless Pacemaker system are the same as with the use of single or dual chamber pacemakers with active fixation pacing leads including, but not limited to: Cardiac perforation, Cardiac tamponade, Pericardial effusion, Pericarditis, Valve damage and/or regurgitation, Heart failure, Pneumothorax/hemothorax, Cardiac arrhythmias, Diaphragmatic/phrenic nerve stimulation / extra-cardiac stimulation, Palpitations, Hypotension, Syncope, Cerebrovascular accident, Infection, Hypersensitivity reaction to device materials, contrast media, medications, or direct toxic effect of contrast media on kidney function, Pacemaker syndrome, Inability to interrogate or program the LP due to programmer or LP malfunction, Intermittent or complete loss of pacing and/or sensing due to dislodgement or mechanical malfunction of the LP (non-battery related), Loss of capture or sensing due to embolization or fibrotic tissue response at the electrode, Increased capture threshold, Inappropriate sensor response, Interruption of desired LP function due to electrical interference, either electromyogenic or electromagnetic, Battery malfunction/ premature battery depletion, Device-related complications (Premature deployment, Device dislodgement/embolization of foreign material, Helix distortion), Death. As with any percutaneous catheterization procedure, potential complications include, but are not limited to: Vascular access complications; such as perforation, dissection, puncture, groin pain, Bleeding or hematoma, Thrombus formation, Thromboembolism, Air embolism, Local and systemic infection, Peripheral nerve damage. General surgery risks and complications from comorbidities; such as hypotension, dyspnea, respiratory failure, syncope, pneumonia, hypertension, cardiac failure, reaction to sedation, renal failure, anemia, and death.
MAT-2306873 v1.0 | Item is approved for US Use
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