Medtronic Expands Denervation Therapy for Hypertension with Multi-Organ Approach

Medtronic, a leading medical device company, has initiated a groundbreaking clinical study to evaluate an expanded approach to renal denervation for treating high blood pressure. The new technique, which targets multiple organs, aims to provide more comprehensive blood pressure control for patients with resistant hypertension.

First Patient Treated in SPYRAL GEMINI Trial

Medtronic recently announced the treatment of the first patient in its SPYRAL GEMINI feasibility trial. This study marks a significant advancement in hypertension therapy by combining traditional renal artery denervation with treatment of the common hepatic artery.

The pilot program successfully completed its first procedure, delivering the therapy to both the renal arteries and the vessels supplying the liver. This multi-organ approach is based on the hypothesis that disrupting nerves in both areas could lead to more effective blood pressure reduction.

Dr. David Kandzari, director of interventional cardiology at the Piedmont Heart Institute and principal investigator of the study, explained, "In addition to denervation of the renal arteries—where the blood pressure lowering clinical benefit has already been established through multiple rigorously designed clinical trials—targeting other richly innervated vascular areas such as the common hepatic artery is an emerging horizon for treating hypertension."

Scientific Rationale and Trial Design

The scientific basis for this expanded approach lies in the anatomical differences between the renal and hepatic arteries. The common hepatic artery carries approximately twice as many nerves compared to the renal arteries, and these nerves are about three times larger. However, the blood vessel itself is similar in size and diameter to the renal arteries, making it a potentially ideal target for denervation therapy.

The SPYRAL GEMINI trial aims to enroll up to 175 patients across the United States, Europe, and Australia. The study is designed with two parallel cohorts based on medication use, allowing researchers to evaluate the effectiveness of the therapy both with and without concurrent antihypertensive medications.

Patients will be followed for up to three years, with the primary endpoint assessing blood pressure changes at three months post-procedure. The trial will utilize a new version of Medtronic's Symplicity Spyral catheter-based system, specifically designed for this multi-organ approach.

Expanding Real-World Evidence

In addition to the SPYRAL GEMINI trial, Medtronic is also gathering real-world data on its Symplicity renal denervation platform. The company recently enrolled the first U.S. patient in a global registry trial, which aims to track the performance of the system as it continues its international commercial rollout.

The Symplicity platform has already been approved by the FDA in November 2023 and is currently available in over 75 countries. Preliminary data from the registry, presented at the EuroPCR conference earlier this year, showed promising results. Among 1,450 patients outside the U.S., the study found declines in office-measured systolic blood pressure of 16.3 mmHg at three years after renal denervation.

As Medtronic continues to expand its research and clinical applications of denervation therapy, the medical community eagerly awaits the results of these innovative approaches to treating resistant hypertension.