Medtronic reported that it has begun testing an expansion of its renal denervation approach for dropping stubbornly high blood pressure, by also treating vessels outside of the kidneys.
The company said its pilot program completed its first patient procedure that delivered the therapy to the renal arteries as well as the vessels feeding the liver—as part of a set of clinical studies that will examine participants both on and off their blood pressure medications.
“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,” the study’s principal investigator, David Kandzari, director of interventional cardiology at the Piedmont Heart Institute, said in a statement.
The thinking is that by disrupting the nerves surrounding the arteries that branch into the liver, the body’s smooth muscles controlling its vascular walls would relax and allow blood to flow more easily, while increasing the volume of blood in the liver itself. Meanwhile, renal denervation would interrupt the overactive signals that are sent to the brain to regulate pressure.
At the same time, the common hepatic artery carries about twice as many nerves compared to the renal arteries, and those nerves are about three times larger, while offering a blood vessel about the same size and diameter.
The SPYRAL GEMINI feasibility trial aims to enroll up to 175 patients in the U.S., Europe and Australia into two parallel cohorts based on medication use, and will track the effect of a new version of Medtronic’s Symplicity Spyral catheter-based system on blood pressure, starting at three months and going out to three years.
Meanwhile, last month, Medtronic also announced that it enrolled the first U.S. patient in its global registry trial, with a real-world study aimed at tracking the performance of the Symplicity platform as it continues its international commercial rollout, which so far has reached more than 75 countries. The system was approved by the FDA in November 2023.
The company presented data from the registry earlier this year at the EuroPCR conference in Paris, gathered from 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.