The top 10 cardiac device stories of 2024

Cardiac device innovations made waves in 2024, with regulatory approvals, clinical breakthroughs, and product launches driving advances in heart care.

Medtech giants like Medtronic, Abbott, and Edwards Lifesciences captured the minds of MassDevice readers alongside news from tech giant Apple, which entered the spotlight with a landmark FDA approval.

The most popular stories of 2024 covered innovations in mapping, monitoring, and minimally invasive procedures, while digital health tools continued to transform patient management. Pulsed-field ablation is an especially hot space.

Based on reader engagement, here are the top 10 cardiac device stories of 2024:

10. FDA approves Medtronic’s Affera cardiac mapping and ablation system and Sphere-9 catheter

Medtronic received FDA approval for its Affera mapping and ablation system with the Sphere-9 catheter. The medtech giant designed the technology to treat persistent atrial fibrillation. It is a high-density mapping, pulsed field ablation, and radiofrequency system that offers radiofrequency ablation for cavotricuspid isthmus dependent atrial flutter.

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9. Medtronic launches next-gen surgical aortic tissue valve

Medtronic launched its next-generation Avalus Ultra surgical aortic tissue valve in April of 2024, offering improved ease of use, long-term durability, and clear visibility for future valve-in-valve procedures. The FDA-cleared device has a low-profile PEEK frame for consistent circularity and an effective orifice area to enhance blood flow. With more complex cases of aortic stenosis, Medtronic aims to meet evolving surgical needs through innovative technologies designed to improve patient outcomes.

Read more about the next-gen surgical aortic tissue valve >>

8. Medtronic touts cost-effectiveness of Linq insertable cardiac monitors

Medtronic released new data from its STROKE AF study showing that its Reveal Linq insertable cardiac monitor (ICM) offers significantly greater cost-effectiveness than standard monitoring methods for post-stroke patients. Continuous AFib monitoring with Linq was associated with fewer ischemic strokes and better long-term patient outcomes, at a cost well below the U.S. willingness-to-pay threshold. Medtronic said the findings further solidify the economic and clinical value of its ICMs in managing atrial fibrillation and preventing secondary strokes.

Read more study results >>

7. Abbott is launching its latest Navitor TAVI system in the U.S.

Abbott launched its latest Navitor Vision transcatheter aortic valve implantation (TAVI) system in the U.S. The system features highly visible markers for optimal implantation depth and is marketed as Abbott’s largest valve with the smallest delivery system. This design helps improve access to coronary arteries to facilitate future procedures that treat coronary artery disease.

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6. Edwards wins FDA approval for its Evoque replacement tricuspid valve

Edwards Lifesciences won FDA approval for its Evoque tricuspid valve replacement system. The company said it was the first transcatheter therapy to receive an FDA nod to treat tricuspid regurgitation. The system has a nitinol self-expanding frame, intra-annular skirt, and tissue leaflets made from bovine pericardial tissue.

Read more about the Evoque replacement tricuspid valve >>

5. Canary Medical has first-in-human implant of heart sound monitor

Canary Medical completed its first-in-human limited feasibility trial of its cardiac auscultation monitoring device. The company designed it as an implantable sensor that provides daily adjunctive objective cardiac parameter measurements. In a two-person trial, the device demonstrated visible mitral regurgitation sound signals from the sensor compared to normal acoustic heart signals.

Read more about the heart sound monitor >>

4. Medtronic wins CE mark for next-gen Micra leadless pacemakers

Medtronic won CE mark approval for its Micra AV2 and Micra VR2 miniature, leadless pacemakers in January 2024. The new pacemakers have a longer battery life and easier programming than earlier versions, touting a battery life of nearly 16 and 17 years, respectively. Micra devices also offer remote monitoring capabilities, potentially reducing hospitalizations and increasing the patient’s sense of security.

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3. Abbott completes first-in-human leadless left bundle branch area pacing procedures

Abbott announced it completed the world’s first human leadless left bundle branch area pacing (LBBAP) cases using its Aveir conduction system pacing leadless pacemaker. Abbott said that Aveir could mimic the heart’s natural beat, giving patients with slower-than-normal heart rhythms a potential new treatment. The company has FDA breakthrough device designation for Aveir.

Read more about the implants and the device >>

2. Abbott announces first procedures with Volt pulsed field ablation system

Abbott announced the first global procedures using its Volt pulsed field ablation in January 2024. Volt treats patients who are battling common abnormal heart rhythms, such as atrial fibrillation (AFib). It pairs a balloon-in-basket catheter with the EnSite X EP heart mapping system to help physicians visualize and position the Volt PFA catheter in the heart.

Get more information about the first procedures and the pulsed field ablation technology >>

1. Apple Watch’s AFib detection tool earns landmark FDA approval

Apple won FDA approval for its AFib detection tool on its Apple Watch. It was the first digital health technology that qualified under the Medical Device Development Tools program. Apple designed the AFib technology as a biomarker test to evaluate estimates of AFib burden as a secondary effectiveness endpoint within clinical studies to help evaluate the safety and effectiveness of cardiac ablation devices in AFib treatment.

Read about the approval >>