US-based Ablative Solutions has announced that its alcohol-mediated renal denervation with the Peregrine System Kit achieved the primary endpoint in the Phase III TARGET BP I trial.

The sham procedure-controlled TARGET BP I trial (NCT02910414) investigated the safety and efficacy of the Peregrine System Kit in patients with uncontrolled hypertension while taking anti-hypertensive medications.

The device met achieved the primary endpoint by demonstrating a statistically significant difference in 24-hour ambulatory blood pressure between treatment and sham procedure at three months.

Renal denervation systems use radiofrequency or ultrasound to ablate afferent and efferent nerves in the renal artery that communicate with the brain and help control blood pressure. Reducing the functionality of these pathways leads to various blood pressure-lowering mechanisms. These procedures are useful in the treatment of uncontrolled hypertension.

The Peregrine System Kit comprises a patented infusion catheter and dehydrated alcohol. It can be used in a minimally invasive procedure to ablate the sympathetic nerves surrounding the renal arteries to reduce blood pressure.

Peregrine system trial

The TARGET BP I trial enrolled 301 patients with uncontrolled hypertension despite being prescribed two to five anti-hypertensive medications. The study remained blinded through six months of follow-up.

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The secondary outcomes measured major adverse events at different time points till three years post-procedure and changes or a decrease of over 25% in estimated glomerular filtration rate (eGFR), which measures kidney function with a decrease in eGFR signifying worsening kidney function.

The trial also measured device success, which was defined as “successful introduction of the catheter, navigation to the treatment site, deployment of the needles, and infusion of the alcohol to the intended area via the Peregrine Catheter as intended for use”, as per ClinicalTrials.gov. In addition to reporting adverse effects and procedure success measured using hospital discharge date (an average of one day)

Renal denervation landscape

The interest in developing renal denervation has been increasing in recent years, with large medtech companies developing these devices. In October, Recor Medical reported positive six-month follow-up data from three trials investigating its Paradise ultrasound renal denervation system, which is approved by the US Food and Drug Administration (FDA). In July, Verve Medical launched a trial to investigate the safety and efficacy of its renal denervation system. The company plans the trial results to inform the US approval for the device.

But it has not been smooth sailing for all. FDA’s advisory panel did not recommend the pre-market approval of Medtronic’s Simplicity Spyral renal denervation system. Although the panel was convinced of the device’s safety, its efficacy was a point of discussion as one of the Simplicity device trials, SPTRAL HTN-ON MED (NCT02439775), failed to meet its primary endpoint.