Medtronic plc is an American Irish-domiciled medical device company that generates the majority of its sales and profits from the U.S. healthcare system but is headquartered in the Republic of Ireland for tax purposes. Medtronic has an operational and executive headquarters in Fridley, Minnesota in the U.S. In 2015, Medtronic acquired Irish–tax registered Covidien (a U.S. tax inversion to Ireland from 2007), in the largest U.S. corporate tax inversion in history, which enabled Medtronic to move its legal registration from the U.S. to Ireland. Medtronic operates in 140 countries and employs over 100,000 people.
AIMS:Radiofrequency (RF) renal denervation (RDN) safely lowers office and 24-h blood pressure (BP). This meta-analysis examined the long-term durability of RF RDN based on randomized trials and observational studies. METHODS AND RESULTS:Patients with uncontrolled hypertension undergoing RF RDN using the Symplicity Flex™ or Spyral™ device and a minimum follow-up of 3 years were included. Key outcomes included office and 24-h BP change from baseline as well as changes in anti-hypertensive drugs. A random effects meta-analysis was conducted over 3 years, or the last reported follow-up beyond 3 years. A total of 2212 patients identified among 18 reports were evaluated for BP. The mean duration of follow-up was 4.4 years (range 3-9.4). The long-term reduction in office systolic BP from baseline in 15 reports (n = 2040) was -23.0 mmHg (95% confidence interval: -26.8 to -19.1, P < 0.05) for the random effects model and -20.5 (-21.6 to -19.4) for the fixed effect model. Twenty-four-hour ambulatory systolic BP was available in 11 reports (n = 1018) and decreased significantly by -13.6 mmHg (-16.5 to -10.8, P < 0.05). Fixed effect model results were similar. Diastolic office and 24-h BP paralleled these findings in both models. Nighttime systolic BP also decreased significantly by -14.2 mmHg (-27.6 to -0.8, P < 0.05). The number of prescribed anti-hypertensive drugs and eGFR also decreased. Heart rate remained unchanged through the final follow-up in both models. Safety events were rare, with a mean rate of renal artery complications of 0.14% (0.08-0.20%). CONCLUSION:This meta-analysis comprising 18 studies demonstrated sustained and significant office and ambulatory BP reductions following Symplicity RDN through at least 3 years without an increase in anti-hypertensive medication.
In this real-world analysis, we evaluated glycemia and insulin delivery in Italian children using the MiniMed 780G system during auto mode use, comparing days with a school routine to out-of-school (OOS) days. Data from 1341 users, self-reported under 16 years old and with type 1 diabetes (T1D), showed no meaningful difference in time in range (TIR) between school days (73.4%) and OOS days (72.4%), and international targets were met on average during both types of day. Minor sensor glucose variations were observed during school hours, such as a more pronounced glucose peak after breakfast and a clearer dip before lunch on school days. The insulin delivery algorithm effectively managed these fluctuations. Maintaining optimized glycemia during both school and OOS days may enhance learning and support cognitive and brain development.
Rationale As neurostimulation devices increasingly incorporate closed-loop functionality, the greater design complexity brings additional requirements for risk management and special considerations to optimize benefit. This manuscript creates a common framework on which all current and planned neuromodulation-based physiologic closed-loop controllers (PCLCs) can be mapped, including integration of the “Technical Considerations of Medical Devices with Physiologic Closed-Loop Control Technology” guidance published in 2023 by the United States Food and Drug Administration, a classification of feedback (reactive) and feedforward (predictive) biomarkers, and control systems theory. Results and Conclusions We explain risk management in the context of this framework and illustrate its applications for three exemplary technologies. This manuscript serves as guidance to the emerging field of PCLCs in neuromodulation, mitigating risk through standardized nomenclature and a systematic outline for rigorous device development, testing, and implementation.
Background:Atrial fibrillation (AF) prevalence has increased with Japan's aging population. Data on cryoballoon ablation (CBA) for persistent AF (PsAF) in Japan is limited. This study reports CBA clinical outcomes in PsAF patients in Japan from the prospective Cryo Global Registry. Methods:Data was analyzed from 60 Japanese centers with 1226 PsAF patients that underwent CBA. The primary endpoints were serious adverse events and freedom from atrial arrhythmia (AA) recurrence, at 12 months. The effect of ablation strategy (pulmonary vein isolation [PVI] or PVI with additional ablations [PVI+]) was evaluated. Quality-of-life (QoL) was measured by EQ-5D-3L questionnaire. Results:The patient mean age was 68 ± 10 years and 29.0% were female. The overall 12-months Kaplan-Meier (KM) estimate for freedom from AA recurrence was 84.4% (95% CI: 82.2%-86.3%). Among PVI+ patients, 33.0% received cavotricuspid isthmus (CTI) and 34.6% received non-CTI ablation (majority being left-atrial roofline [27.2%]). The 12-months KM estimate for freedom from AA recurrence was higher for PVI+ subgroup (86.6% [CI: 83.6%-89.1%]) than PVI subgroup (82.0% [CI: 78.6%-84.9%]) (HR adj = 1.40, p = 0.025). Twenty-two serious adverse events were reported in 1.6% patients. At 12 months, compared to baseline, QoL improved with a mean summary-index score difference of 0.03 ± 0.16 (p < 0.001) and a mean EQ visual analogue scale score difference of 7.9 ± 18.5 (p < 0.001). Conclusion:This study showed CBA is safe and effective for PsAF treatment in real-world use in Japan. Trial Registration:Cryo Global Registry, ClinicalTrials.gov ID NCT02752737.
Background In 2024, the UK National Institute of Health and Care Excellence (NICE) recommended TriageHF alerts as an option for remote monitoring of patients with heart failure (HF) and a compatible cardiac implantable electronic device (CIED). Data on the cost-effectiveness of this approach has not been published. This research evaluates the cost-effectiveness of TriageHF Plus in public hospital settings, using data from the TriageHF Plus multicentre study (758 participants, NCT04177199 ). Methods An economic model was developed to capture the lifetime cost and benefits of TriageHF Plus versus usual care, based on a site of 300 eligible patients. Analysis on individual patient-level data informed model efficacy and resource use parameters. EuroQol five-dimensional questionnaire data and unit costs were obtained from published, peer-reviewed literature and national databases respectively. Costs and benefits were discounted at 3.5% per annum to adjust future costs and benefits to present value. Results In a site size of 300, TriageHF Plus was predicted to prevent 384 (363–405) hospitalisations over 5 years. In total, TriageHF Plus saved £3989 (£1812–£5563) per person-lifetime versus usual care and was more effective and cost-saving in 99.4% of simulations. Results were robust to changes in key input parameters. Modelling showed that to avoid one hospitalisation, 1.7 people would need lifetime access to TriageHF Plus. Conclusion The TriageHF Plus pathway is cost-effective for the remote monitoring of HF in patients with CIEDs. Trial registration number NCT04177199 .
