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FOR U.S. HEALTHCARE PROFESSIONALS AND QUALIFIED HEALTH SYSTEM DECISION-MAKERS ONLY: This page is intended exclusively for U.S. healthcare professionals (HCPs), health system administrators, value analysis teams, and payer audiences. It is not intended for patients or the general public. Important Safety Information
Enduring Evidence.
Consistent Performance.
Seven abstract presentations bring you the
latest wave of evidence on Paradise Ultrasound
Renal Denervation for hypertension care.
Real-world Outcomes*
Across diverse real-world clinical settings – from the GPS registry to amulticenter U.S. experience – Paradise uRDN demonstrated consistent performance, with meaningful and durable blood pressure reductions,procedural efficiency, and a strong safety profile.
*The content below summarizes scientific abstracts presented at TCT 2026 (Transcatheter Cardiovascular Therapeutics, October 2026). These abstracts represent preliminary data that have not yet been published in peer-reviewed journals. Data are presented for informational and scientific exchange purposes only. Individual patient results may vary. Sample sizes, study designs, and limitations should be considered when interpreting the findings.
12-month outcomes from the GPS Registry
Mahfoud et al.
In this real-world GPS Registry analysis (N=276), Paradise uRDN reduced office SBP by 19.5 mmHg among patients with complete 12-month follow-up and maintained a favorable safety profile. Additionally, patients with a history of hypertensive crisis experienced greater BP reductions, reaching 22.0 mmHg at 12 months.
U.S. experience and outcomes across multiple centers
Tehrani et al.
In U.S. real-world analysis of 238 patients, across 8 hospitals, Paradise uRDN demonstrated excellent procedural performance and safety. Among pooled patients with complete longitudinal follow-up, office BP reduction was 26.9 mmHg through 12 months. Efficacy composite was 93.5% and clinical success was 100%.
Long-term durability
Blood pressure outcomes through four years
Kirtane et al.
In pooled RADIANCE pivotal clinical program (N=293), Paradise uRDN was associated with durable, clinically meaningful reductions in office systolic BP of 14.9 mmHg, maintained through 4 years.
Hospital economic value
Hospital-perspective economic analysis
Atreja et al.
In this conservative analysis of the pooled RADIANCE pivotal clinical program (N=509), the Paradise uRDN improved BP control and was associated with a lower cardiovascular event rate in patients with uncontrolled hypertension. These benefits were associated with lower hospitalization costs and fewer hospital days, supporting economic value in routine clinical practice.1
1. uRDN's indication is for BP reduction, not cardiovascular event reduction. This information is provided as disease state awareness.
Patient-centric insights and care gaps
Patient-centered procedure under moderate sedation
Atreja et al.
Paradise uRDN under moderate sedation was well-tolerated (N=31), with low peri-procedural pain and high patient satisfaction. Moderate sedation with individualized analgesic protocols supported patient comfort, procedural efficiency, and rapid recovery.
Hypertension undertreatment in patients with CAD
Mehran et al.
Among 2,285 hypertensive patients undergoing staged PCI, nearly 40% of hypertensive patients had uncontrolled BP at both index and staged PCI. Uncontrolled BP at staged PCI was linked to a 49% higher risk of 1-year adverse cardiovascular events, largely driven by MI. Treatment intensification was uncommon, identifying the interval between procedures as a missed opportunity for BP optimization.2
2. This disease-state information highlights an unmet need in hypertension management and does not constitute a claim regarding Paradise uRDN in this patient population.
Outcomes across hypertension phenotypes
Delgado-Lelievre et al.
In this real-world cohort, including salt-sensitive and aldosterone-sensitive hypertension phenotypes (N=10), Paradise uRDN was associated with reductions in office and 24-hour ambulatory systolic BP. Improvements in nocturnal dipping suggested a beneficial effect on circadianBP regulation.
Paradise® Ultrasound Renal Denervation System is designed to set a new standard in hypertension treatment.
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The PARADISE® system is FDA approved for sale in the United States and is CE 2797 marked and approved for sale in markets where the CE 2797 mark is accepted, per approved indications for use, and received regulatory approval in Japan.
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