Patient initially received treatment in Medtronic's initial trial for the multi-organ SPYRnal GEMINI Research Project
The global healthcare giant, Medtronic, has recently initiated the SPYRAL GEMINI Pilot study, a groundbreaking prospective, multicentre, international feasibility trial. This study aims to investigate the safety and potential efficacy of multi-organ denervation (MDN) for patients suffering from uncontrolled hypertension.
## Objective and Design
The primary objective of the SPYRAL GEMINI Pilot study is to evaluate the feasibility of combined denervation of both the renal and common hepatic arteries in patients with uncontrolled hypertension, using the Symplicity Spyral catheter. The study includes two parallel cohorts: one for patients who are off antihypertensive medications (OFF MED) and another for patients on these medications (ON MED).
## Participants and Locations
The study aims to enroll up to 175 patients in three key geographies: the United States, Europe, and Australia.
## Multi-Organ Denervation Approach
The study employs two main approaches: renal denervation and hepatic denervation. Renal denervation, a procedure that targets the renal arteries, has already demonstrated blood pressure benefits through prior trials. Hepatic denervation, an emerging area for hypertension treatment, is currently limited to clinical investigation in all geographies.
## Evaluation and Outcomes
The study will assess procedural safety and efficacy at 3 months and continue evaluations up to 36 months post-procedure. The data collected will be used for hypothesis generation, with no pre-specified primary endpoint, setting the stage for further clinical investigations.
## Preclinical Data
Preclinical data for the Spyral system showed a 90% significant reduction in norepinephrine (a marker of sympathetic activity) with multi-organ denervation.
Dr. David Kandzari serves as the lead principal investigator of the SPYRAL GEMINI pilot study. The first patient in the program was treated by Dr. Barry Bertolet. The study will be conducted using the Symplicity Spyral catheter, a low profile and single catheter design that Medtronic is committed to exploring for its clinical potential in multi-organ denervation.
The SPYRAL GEMINI Pilot study represents a significant step in exploring multi-organ denervation as a potential approach for managing uncontrolled hypertension by targeting both renal and hepatic arteries. With this study, Medtronic reaffirms its commitment to investing in strategically important areas that hold promise for patients and the medical community.
[1] [Medtronic press release on SPYRAL GEMINI Pilot study](https://www.medtronic.com/us-en/about-medtronic/news/press-releases/2021/09/medtronic-announces-initiation-of-spyral-gemini-pilot-study-to-investigate-multi-organ-denervation-for-patients-with-uncontrolled-hypertension.html) [2] [ClinicalTrials.gov listing for SPYRAL GEMINI Pilot study](https://clinicaltrials.gov/ct2/show/NCT05104293) [3] [European Society of Cardiology press release on SPYRAL GEMINI Pilot study](https://www.escardio.org/The-ESC/Press-Office/Press-releases/Latest-press-releases/ESC-News-from-the-TCT-2021-Congress---Medtronic-announces-initiation-of-the-SPYRAL-GEMINI-Pilot-Study-to-investigate-multi-organ-denervation-for-patients-with-uncontrolled-hypertension)
- This SPYRAL GEMINI Pilot study, initiated by Medtronic, is a significant step in digital health, as it investigates the safety and potential efficacy of multi-organ denervation (MDN) for patients with uncontrolled hypertension.
- The study's design includes two parallel cohorts: one for patients off antihypertensive medications (OFF MED) and another for patients on these medications (ON MED), to evaluate the feasibility of combined denervation of both the renal and common hepatic arteries using the Symplicity Spyral catheter.
- The results of this study, conducted in the United States, Europe, and Australia, could potentially contribute to the science of health-and-wellness, particularly in the field of cardiovascular health, as it aims to address uncontrolled hypertension through a novel approach of targeting both renal and hepatic arteries.
