Paradise Renal Denervation System Clinical Evidence

Azizi et al. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single- blind, sham-controlled trial. Lancet. 2021. In press

Azizi et al. Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control Following Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial. Circulation. 2019;139:2542–2553.

Daemen et al.  Safety and Efficacy of Endovascular Ultrasound Renal Denervation in Resistant Hypertension: 12-month Results From the ACHIEVE Study. J Hypertens. 2019;37(9):1906-1912.

Fengler et al.  Predictors for profound blood pressure response in patients undergoing renal sympathetic denervation. J Hypertens. 2018 Jul;36(7):1578-1584.

Azizi et al.  Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018 Jun 9;391(10137):2335-2345.

Mauri et al.  A multinational clinical approach to assessing the effectiveness of catheter-based ultrasound renal denervation: The RADIANCE-HTN and REQUIRE clinical study designs. Am Heart J. 2018 Jan;195:115-129.

Fengler et al.  Ultrasound-based renal sympathetic denervation for the treatment of therapy-resistant hypertension: a single-center experience. J Hypertens. 2017 Jun;35(6):1310-1317.

Stiermaier et al.  Endovascular ultrasound for renal sympathetic denervation in patients with therapy-resistant hypertension not responding to radiofrequency renal sympathetic denervation. EuroIntervention. 2016 Jun 12;12(2):e282-9.

Daemen et al.  First-in-man radial access renal denervation with the ReCor Radiance catheter. EuroIntervention. 2015 Feb;10(10):1209-12.

Pathak et al. Renal sympathetic nerve denervation using intraluminal ultrasound within a cooling balloon preserves the arterial wall and reduces sympathetic nerve activity. EuroIntervention. 2015 Aug;11(4):477-84.

Fengler et al. A Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension (RADIOSOUND-HTN). Circulation. 2019 Jan 29;139(5):590-600.

Sakakura et al. Controlled circumferential renal sympathetic denervation with preservation of the renal arterial wall using intraluminal ultrasound: a next-generation approach for treating sympathetic overactivity EuroIntervention. 2015 Feb;10(10):1230-8.



Böhm et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020;395(10234):1444–1451.

Schmieder et al.  European Society of Hypertension position paper on renal denervation 2018. J Hypertens. 2018 Oct;36(10):2042-2048.

Schlaich et al.  Renal Denervation—Ready for Prime Time!? The Steep SPYRAL Stairs to RADIANCE in Hypertension Treatment. Hypertension. 2018 Aug;72(2):287-290

Kandzari et al.  Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355.

Townsend et al.  Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017 Nov 11;390(10108):2160-2170.

Azizi et al.  Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial. Lancet. 2015 May 16;385(9981):1957-65.

Völz et al.  Renal sympathetic denervation in Sweden: a report from the Swedish registry for renal denervation. J Hypertens. 2018 Jan;36(1):151-158.

Fengler et al.  Pulse Wave Velocity Predicts Response to Renal Denervation in Isolated Systolic Hypertension. J Am Heart Assoc. 2017 May 17;6(5).

Kandzari et al.  The SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. Am Heart J. 2016 Jan;171(1):82-91.

Mahfoud et al.  Proceedings from the 2nd European Clinical Consensus Conference for device-based therapies for hypertension: state of the art and considerations for the future. Eur Heart J. 2017 Nov 21;38(44):3272-3281.

Mahfoud et al.  Proceedings from the European clinical consensus conference for renal denervation: considerations on future clinical trial design. Eur Heart J. 2015 Sep 1;36(33):2219-27.

Sakakura et al.  Controlled circumferential renal sympathetic denervation with preservation of the renal arterial wall using intraluminal ultrasound: a next-generation approach for treating sympathetic overactivity. EuroIntervention 2015; 10: 1230–8.