Abbott Levels-Up Wireless Pacemaker Tech

Abbott’s Aveir VR pacemaker helps with slow heart rhythms, gives competitive boost to cardiac rhythm management.

Strategy and Strength|Apr.12, 2022

Abbott is leveling-up leadless pacemaker technology with its new Aveir single-chamber VR pacemaker system, which features increased battery longevity over current commercially available leadless pacemakers*1 and the ability to be retrieved if therapy needs change in the future.

The minimally invasive device — implanted in the heart’s right ventricle to treat slower-than-normal heart rates — was recently approved by the U.S. Food and Drug Administration (FDA). This approval gives Abbott a competitive boost in the cardiac rhythm management space, and reflects Abbott’s continued push to develop leadless cardiac technology, which features a reduction in post-implant complications related to leads (flexible wires connecting the pacemaker to the heart).

In fact, the Aveir VR Leadless Pacemaker system is an important component of Abbott’s broader leadless-pacing strategy. This strategy includes developing a dual-chamber leadless pacemaker — currently in clinical trial and not yet commercially available — designed for people who need both heart chambers paced at the same time.

Considering nearly 80% of people2,3,4 who receive a pacemaker need a dual-chamber option and that there isn’t currently a leadless dual-chamber pacemaker on the market, Abbott has strong potential to expand in the $1.5 billion U.S. pacing market.5

“Leadless pacing is a major pipeline program for ABT’s Rhythm Management division,” Cowen analysts wrote in a recent report. “We view Aveir’s approval as another example of ABT advancing its key growth drivers while navigating macro and micro challenges.”6

Aveir’s Competitive Advantage

FDA approval of the Aveir VR Leadless Pacemaker system was supported by data from the global LEADLESS II phase 2 investigational device exemption study, which evaluated the device in people with certain abnormal heart rhythms. The results showed the device met its pre-specified primary endpoints.

Setting Abbott’s Aveir VR Leadless Pacemaker system apart are three critical, never-before-seen features in a leadless pacemaker:

  • Unique mapping capability is designed to allow physicians to measure electrical signals within the heart and detect the correct placement of the device before final implantation.
  • Increased battery life is projected to be up to two times longer than other commercially available leadless pacemakers when using the International Organization for Standardization settings.1
  • Designed to be retrieved7 if a person’s therapy needs evolve.

What’s Next?

Abbott is looking ahead to designing next-generation cardiac rhythm management technology that is expandable — focusing on enabling devices to be interchanged as different cardiac therapies are needed — and that is designed to communicate with one another inside the heart. The foundational innovations designed in the Aveir VR Leadless Pacemaker system provide the first step toward these future advancements.

“Our goal is to continue to build on the success of the Aveir VR Leadless Pacemaker to provide more first-of-their-kind products in the future, revolutionizing how abnormal heart rhythms are treated,” said Randel Woodgrift, senior vice president of Cardiac Rhythm Management at Abbott.

Learn more about Abbott’s Aveir VR Leadless Pacemaker system and its other game-changing heart tech.


*When using International Organization for Standardization (ISO) settings


References

1International Organization for Standardization (ISO) VVIR settings: 2.5V@0.4ms, 600 Ω, 60 bpm, 100% pacing.

2Bernstein AD, Parsonnet V. Survey of cardiac pacing and defibrillation in the United States in 1993. American Journal of Cardiology. 1996;78(2):187. doi:10.1016/S0002-9149(96)90394-X.

3Acosta Velez JG, Amit G, Hernández Ruiz EA, Trusz-Gluza M, Leśniak W. Sinus Node Dysfunction. McMaster Textbook of Internal Medicine. Kraków: Medycyna Praktyczna.

https://empendium.com/mcmtextbook/chapter/B31.II.2.7.1. Accessed December 03, 2021.

4Hongo RH, Goldschlager NF. Chapter 14. Conduction Disorders & Cardiac Pacing. In: Crawford MH. eds. Current Diagnosis & Treatment: Cardiology, 4e. McGraw Hill; 2014. Accessed December 03, 2021. https://accessmedicine.mhmedical.com/content.aspx?bookid=715&sectionid=48214546 Reynolds D, Duray GZ, Omar R, et al. A Leadless Intracardiac Transcatheter Pacing System. The New England journal of medicine. 2016;374(6):533-541. doi:10.1056/NEJMoa1511643

5Data on file, Abbott Investor Relations.

6Cowen, More Pipeline Progress, As Leadless Pacemaker Receives FDA Approval, April 4, 2022.

7The Aveir Retrieval Catheter is pending FDA 510k clearance and is not available for sale.

IMPORTANT SAFETY INFORMATION

AVEIR™ LEADLESS PACEMAKER SYSTEM

Rx Only

Brief Summary: Prior 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: The Aveir™ Leadless Pacemaker system is indicated for patients with significant bradycardia and:

▪ Normal sinus rhythm with rare episodes of A-V block or sinus arrest

▪ Chronic atrial fibrillation

▪ Severe physical disability

Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity.

Intended Use: The Aveir™ 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. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy to the target patient population.

The Aveir™ Delivery Catheter system 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: Use of the Aveir™ Leadless Pacemaker is contraindicated in these cases:

Use of any pacemaker is contraindicated in patients with a co-implanted ICD because high-voltage shocks could damage the pacemaker and the pacemaker could reduce shock effectiveness.

Single-chamber ventricular demand pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing.

Programming of rate-responsive pacing is contraindicated in patients with intolerance of high sensor-driven rates.

Use is contraindicated in patients with an implanted vena cava filter or mechanical tricuspid valve because of interference between these devices and the delivery system during implantation.

Persons with known history of allergies to any of the components of this device may suffer an allergic reaction to this device. Prior to use on the patient, the patient should be counseled on the materials (listed in Product Materials section in IFU) contained in the device and a thorough history of allergies must be discussed.

Adverse Events: Potential complications associated with the use of the Aveir™ Leadless Pacemaker system are the same as with the use of single 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, 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).

MOST READ