CLINICAL EVIDENCE

Effective. Lasting. Proven.
Effective. Lasting. Proven.

The Paradise™ Ultrasound RDN system has been tested and proven effective across multiple clinical trials, including Recor’s RADIANCE™ global program and the ACHIEVE study. With statistically significant and durable results, the Paradise™ system can offer a new, clinically meaningful therapy option for you and your patients.

Met primary endpoints in

3/3

U.S. and Europe randomized
controlled trials1-3

1. Azizi et al. JAMA. 2023;329(8):651-661  2. Azizi et al. Lancet. 2018 Jun 9;391(10137):2335-2345.  3. Azizi et al. Lancet. 2021 Jun 26;397(10293):2476-2486.

Endpoints met. With significance.
The RADIANCE™ global program.

Through the successful RADIANCE global program, the Paradise™ system became the only RDN modality to meet its primary efficacy endpoint in three separate powered, randomized controlled trials (RCTs) in the U.S. and Europe. Furthermore it is the only RDN system to prove efficacy in resistant hypertension via a controlled trial.1-4

RADIANCE-HTN SOLO

Mild-to-moderate hypertension

RADIANCE-HTN TRIO

Resistant hypertension

RADIANCE II

Mild-to-moderate hypertension

The RADIANCE-HTN clinical trials:

  • Sham controlled
  • Individually powered
  • Demonstrated effectiveness in lowering blood pressure at two months and beyond

The Paradise™ Ultrasound RDN system met the primary blood pressure reduction endpoints in all three RADIANCE global program RCTs to date.

uRDN
(N=74) -2.2 mmHg Sham
(N=72) -6.3 mmHg (p=0.0001) -8.5 mmHg 0 -5 -10
 SOLO Off-Med ¹ uRDN
(N=150) -1.8 mmHg Sham
(N=74) -6.3 mmHg (p=<0.0001) -7.9 mmHg 0 -5 -10
 RADIANCE II Off-Med ² uRDN
(N=74) -3.0 mmHg Sham
(N=72) -4.5 mmHg (p=0.022) -8.0 mmHg 0 -5 -10
 TRIO on 3 Meds ³ Mild-to-moderate hypertension Resistent hypertension Primary efficacy endpoint at 2 months Daytime Ambulantory SBO (mmHg) Daytime Ambulantory SBO (mmHg) Daytime Ambulantory SBO (mmHg)

*individual group changes are based on observed values uRDN N=145 and Sham N=73
1. Azizi et al. Lancet. 2018 Jun 9;391(10137):2335-2345. 2. Kirtane et al. TCT2022 3. Azizi et al. Lancet. 2021 Jun 26;397(10293):2476-2486. 4. Kirtane et al. JAMA Cardiol. 2023;8(5):464-473. 5. Rader et al. EuroIntervention 2022;18:e677-e685

Ultrasound RDN was demonstrated to be safe from procedure to 36 months.5

3

years

Ultrasound RDN has consistently proven to be safe and effective across three RADIANCE randomized controlled trials studying more than 500 patients.1-4

1. Azizi et al. Lancet. 2018 Jun 9;391(10137):2335-2345. 2. Kirtane et al. TCT2022 3. Azizi et al. Lancet. 2021 Jun 26;397(10293):2476-2486. 4. Kirtane A. et al. JAMA Cardiol. 2023;8(5):464-473. 5. Rader et al. EuroIntervention 2022;18:e677-e685

Lasting, powerful results.

Paradise™ Ultrasound RDN delivers continuous 24-hour blood pressure reductions independent of time and medication adherence.

Combined analysis of RADIANCE trials1

1. Kirtane et al. JAMA Cardiol. 2023;8(5):464-473

>10 mmHg BP reduction. Less ablation time.

RADIOSOUND-HTN *¹ ² trial

Randomized head-to-head comparison of Ultrasound RDN and Radiofrequency RDN

With short 7-second bursts of ultrasound energy and 2-3 treatments in each main renal artery, Paradise™ Ultrasound RDN delivers meaningful reductions in blood pressure while shortening fluoroscopy time and reducing contrast load.

< 1.0 mins
 98.7 mL
 8.1 minutes


-8.3 -15
 RF-RDN
Main + Branches
(N = 39)
 > 8.0 mins 143.1 mL
 16.8 minutes Total ablation
time Contrast agent
used Fluoroscopy
time


-4.8 Less Ablation Time ¹ uRDN Main Only
(N = 42)


-12.1 p < 0.05 Ultrasound RDN Main Only Radiofrequency RDN Main + Branches 3 Months¹
(Daytime ABPM) 6 Months²
(24-hr ABPM) n.s.


-13.2 0 -5 -10
 Change in Systolic ABPM from Baseline
*RADIOSOUND-HTN study enrollment period: 2015-2018. Antihypertensive medications remained stable through 6 months unless indicated by symptomatic hypo- or hypertension.
1. Fengler et al. J Am Coll Cardiol Intv. 2023 Feb, 16 (3) 367–369. 2. Fengler et al. JACC: Cardiovascular Interventions. Vol 16. No. 3. 2023: 359-369.

Resources

Primary endpoint publications

Radiance-HTN solo     Radiance-HTN Trio     Radiance-II