Significant Blood Pressure Reduction Documented in Clinical Studies of Recor Medical's Paradise System

Recent clinical data unveiled at the TCT 2025 conference indicate a substantial decrease in blood pressure of 19.6 mmHg among patients undergoing treatment with the Paradise Ultrasound Renal Denervation (uRDN) system from Recor Medical. This innovative device represents a pivotal advancement in addressing uncontrolled and resistant hypertension. The findings stem from a global registry study, the Global Paradise System (GPS), which monitored participants across nine countries and revealed promising long-term efficacy associated with this renal denervation technology.

Revelations from the Global Paradise System Study

The GPS registry study showcased a significant reduction in systolic clinic blood pressure by 19.6 mmHg after six months. This notable improvement was evident not only in clinical settings but also in home measurements, where systolic blood pressure dropped by 14.4 mmHg from baseline values. These results were shared by Dr. Karl Fengler from Heart Center Leipzig, emphasizing the capability of the Paradise uRDN system to provide meaningful relief for those unable to control their hypertension through medication or lifestyle changes alone.

With a patient demographic that presented a higher risk profile than in previous studies, the GPS study highlights the effectiveness of the Paradise system as a potential game-changer in managing difficult hypertension cases. Furthermore, safety concerns were notably absent, reinforcing the system's viability as a treatment option for patients previously deemed high-risk.

Consistency Across Studies

Another critical aspect discussed at the conference was the pooled analysis derived from the RADIANCE-trial program. Data collected over two years from 243 patients across three studies indicated a sustained reduction in systolic clinic blood pressure by 15.7 mmHg. This corroborates the findings in the GPS study, emphasizing that the hypertensive management benefits of the Paradise system extend well beyond the initial treatment phases.

Being at the forefront of hypertension treatment, Recor Medical's President and CEO, Lara Barghout, articulated the significance of these findings, claiming, "The escalating evidence from medical practice consistently demonstrates that the Paradise uRDN system can substantially lower blood pressure in patients grappling with uncontrolled and resistant hypertension. These results bolster the arguments for the Paradise uRDN system as a safe, durable, and effective treatment option, underscoring its profound real-world impact on patients' lives."

Mechanism and Technological Innovations

The Paradise system employs a novel ultrasound-based renal denervation technology aimed at attenuating the overactivity of sympathetic nerves surrounding the renal arteries—an operation believed to be a contributing factor to hypertension. During the procedure, the device delivers 360-degree ultrasound energy in two to three doses, seven seconds each, to the affected nerves, heralding a new era of treatment for hypertension.

Moreover, the Paradise catheter features the proprietary HydroCooling™ system that circulates sterile water via the balloon catheter, protecting renal artery walls during the procedure. This approach not only enhances patient safety but also optimizes the overall effectiveness of denervation.

Future Inquiries and Market Availability

The FDA granted approval for the Paradise uRDN system in November 2023, paving the way for its commercial availability in the United States. As Recor Medical continues to chart its progress in addressing resistant hypertension, it eagerly anticipates the collection of additional real-world data to further substantiate the long-term efficacy and safety of the Paradise system.

In conclusion, the ongoing clinical evidence associated with the Paradise system positions it as a landmark innovation in hypertension management, particularly for patients who have not responded satisfactorily to conventional treatment methods. By reducing blood pressure significantly, this device might contribute to decreased cardiovascular risks and improve overall quality of life for countless individuals suffering from this chronic condition.

For more information visit Recor Medical and learn about the transformative impact of ultrasound renal denervation.