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Last Updated: Apr 25, 2025 | Study Period: 2024-2030
Pacemakers with no lead are installed. Large global registries have revealed excellent implant success rates, minimal complication rates, and satisfactory electrical parameters up to a year of follow-up.
However, data outside of the experimental context are sparse. The goal of this study is to evaluate the clinical safety and efficacy of Micra TPS (transcatheter pacing system) leadless pacemakers in real-world settings.
Patients with implants from the Micra Transcatheter Pacing System Pre-Marketing Study and the Micra Transcatheter Pacing System Continued Access Study were analyzed and compared to patients with transvenous pacemakers (TVPs).
TPS retrieval/explant, relocation, replacement, or electrical deactivation (with or without prior retrieval attempt, often followed by TVP implant) were all revisions.
Kaplan-Meier revision rates were computed and compared using a Fine-Gray plot to adjust for different follow-up time.
Complications with traditional transvenous pacing devices occur both early, at or near the time of device implantation, and late, months to years afterwards.
Early device difficulties may be caused by problems with the pulse generator or leads, and might include acute lead dislodgement, lead/connector troubles, system infection, or pacemaker syndrome.
Late system issues are more likely to be the consequence of lead failure, pocket and/or lead infection, early battery depletion, or device malfunction.
Regardless of the time, pacing system change is frequently judged required. To improve the pacing system (i.e., add leads and treatments), the pacing system may need to be revised.
Transvenous pacing system revisions occurred at a rate of implant and revision in the FOLLOWPACE research.
Transcatheter Pacing devices (TPS) were created in part to reduce or eliminate the difficulties associated with transvenous pacemaker devices.
Micra TPS is a self-contained VVIR pacemaker that is now available and is put directly into the right ventricle via the femoral vein, removing the need for either a lead or a subcutaneous pocket.
It has the same functionality and capabilities as traditional VVIR pacemakers and can be programmed using a regular programmer.
The TPS can be electrically deactivated and left in place at the conclusion of the service. Furthermore, the gadget has a function for percutaneous snare retrieval and removal.
When compared to transvenous pacemaker devices, all of these features should significantly reduce the requirement for system change with transcatheter pacemakers.
The requirement for system modification and the success rate in revising transcatheter systems have yet to be defined. They aimed to examine the Micra experience to establish the clinical frequency, cause for system revision, and success rate of system modification with this TPS.
The goal of this investigation was to describe the Micra TPS system modification experience. Furthermore, utilizing a preset historical control data set, the Micra TPS system revision rate will be compared to the system revision rate of traditional transvenous pacemakers.TPS retrieval/explant, relocation, replacement, or electrical deactivation (with or without prior retrieval attempt, usually followed by transvenous pacemaker implantation) were all revisions.
In patients with implantation pacemakers, pacemaker system revision is a substantial cause of morbidity and expense.
Transcatheter pacemakers are intended to reduce issues related to the lead and subcutaneous pocket, which are typical causes of transvenous system malfunction and infection.
The gadgets are compact, lack a traditional lead, do not require a pocket, and can be encased fast.
These characteristics should considerably reduce the likelihood of issues necessitating system redesign. In this analysis individuals with TPS, they found a low incidence of system revision and no additional problems due to the Micra modification.
When compared to patients following transvenous pacemaker implantation, the total actuarial risk of problems needing system revision was only through years after installation.
Despite these technical breakthroughs, some patients still require TPS system change due to battery depletion, the necessity for system upgrading (such as a biventricular device), or device difficulties.
they have shown that the Micra TPS device may be withdrawn percutaneously in certain individuals more than a year after implantation.
The Micra TPS is projected to become encapsulated over time; however, because of the small number of patients who have had retrieval attempts, they cannot currently predict when percutaneous retrieval will become unlikely to be successful.
Furthermore, because of its modest size, the TPS may be permanently disabled and left in place, which is likely the preferred option.
There was no electrical or mechanical connection between the devices that were left in situ and the ones that were later implanted.
The significantly lower rate of system revisions with Micra as compared to transvenous pacemakers can be attributed primarily to the lack of dislodgement, low rate of threshold elevation, and lack of infections.
These findings from the transvenous pacemaker cohort demonstrate that the majority of issues requiring system redesign are caused by the lead and pocket.
Micra avoids these dangers due to the lack of a lead and pocket, but the high level of safety may also be ascribed to the unique attachment mechanism.
Micra contains four flexible nitinol tines designed to offer a firm grip on the heart tissue. These times are independent of the pacing electrode, which isolates the heart tissue damage and allows for steady electrical performance.
The Global Transcatheter Pacing System Market accounted for $XX Billion in 2022 and is anticipated to reach $XX Billion by 2030, registering a CAGR of XX% from 2024 to 2030.
Medtronic plc (NYSE:MDT), a worldwide leader in healthcare technology, said today that the Micra AV Transcatheter Pacing System (TPS) has been approved for sale and reimbursement by Japan's Ministry of Health, Labour, and Welfare, and that the device would be available this month.
This clearance boosts the number of patients eligible for the Micra TPS, the world's tiniest pacemaker, in Japan, one of the world's major markets.
The Micra AV is intended to treat individuals with AV block, a disease in which electrical communications between the chambers of the heart (the atria and the ventricle) are impeded.
The Micra TPS pacemaker is the first of its kind; its initial iteration (the Micra VR) was certified in Japan.
Pacemakers have come a long way in their roughly year career, including miniaturization, advancements in pacing technology, MRI compatibility, and remote monitoring.
The initial Micra system revolutionized pacemaker design by eliminating surgical pockets and leads, and Micra AV promises to bring the benefits of leadless pacing to a greater number of patients since ventricular pacing may be conducted concurrently with atrial pacing.
Patients with AV block have traditionally been treated with classic dual-chamber pacemakers, which are placed in the upper chest, beneath the skin below the collar bone, and linked to the heart by thin cables known as leads.
Micra AV is the same size and form as the original Micra TPS, but it contains numerous extra algorithms that detect cardiac movement, allowing the device to alter pacing in real time.
Sl no | Topic |
1 | Market Segmentation |
2 | Scope of the report |
3 | Abbreviations |
4 | Research Methodology |
5 | Executive Summary |
6 | Introduction |
7 | Insights from Industry stakeholders |
8 | Cost breakdown of Product by sub-components and average profit margin |
9 | Disruptive innovation in the Industry |
10 | Technology trends in the Industry |
11 | Consumer trends in the industry |
12 | Recent Production Milestones |
13 | Component Manufacturing in US, EU and China |
14 | COVID-19 impact on overall market |
15 | COVID-19 impact on Production of components |
16 | COVID-19 impact on Point of sale |
17 | Market Segmentation, Dynamics and Forecast by Geography, 2024-2030 |
18 | Market Segmentation, Dynamics and Forecast by Product Type, 2024-2030 |
19 | Market Segmentation, Dynamics and Forecast by Application, 2024-2030 |
20 | Market Segmentation, Dynamics and Forecast by End use, 2024-2030 |
21 | Product installation rate by OEM, 2023 |
22 | Incline/Decline in Average B-2-B selling price in past 5 years |
23 | Competition from substitute products |
24 | Gross margin and average profitability of suppliers |
25 | New product development in past 12 months |
26 | M&A in past 12 months |
27 | Growth strategy of leading players |
28 | Market share of vendors, 2023 |
29 | Company Profiles |
30 | Unmet needs and opportunity for new suppliers |
31 | Conclusion |
32 | Appendix |