Sign up for the QMED & MD+DI Daily newsletter.
The Redemption Arc Continues for the Renal Denervation Space
Ablative Solutions is the latest company to have a significant milestone in using renal denervation to treat hypertension.
December 19, 2023
1 Min Read
Image Credit: Everyday better to do everything you love via iStock / Getty Images
The good news for renal denervation to treat hypertension is pouring in after years of the space being flooded with failed trials and negativity.
Ablative Solutions shared today that it has met the primary endpoint for a pivotal trial of the Peregrine System kit to treat patients with uncontrolled hypertension.
The Wakefield, MA-based company’s Peregrine System kit, is comprised of an infusion catheter and dehydrated alcohol, which is used during a minimally invasive procedure to ablate the sympathetic nerves surrounding the renal (kidney) arteries to reduce blood pressure.
The TARGET BP I Trial enrolled patients with uncontrolled hypertension despite being prescribed two to five antihypertension medications. A total of 301 patients were randomized to either receive treatment with the Peregrine System Kit or sham procedure. The study remained blinded through six months follow-up.
"We are happy to announce the completion of the primary analysis of this landmark trial and are excited for the potential of alcohol-mediated renal denervation as a treatment option addressing the widespread public health issue of uncontrolled hypertension", stated David Kandzari, M.D., co-principal investigator, chief of Piedmont Heart Institute and chief scientific officer for Piedmont Healthcare. "We look forward to sharing these data in the coming months.”
Renal Denervation Redeemed in 2023
Recor Medical and Medtronic helped change the paradigm on renal denervation for hypertension by both winning recent FDA nods.
Recor scored success first by securing approval in November for the Paradise ultrasound renal denervation system. The approval was a milestone in a plagued space that many companies such as Boston Scientific and St. Jude (abandoned).
Medtronic, which had failed renal denervation trials and FDA rejections in the past, finally received redemption. The Dublin-based company’s Symplicity Spyral renal denervation system was green lit by FDA in November.
About the Author(s)
You May Also Like
Pedersen's POV graphic featuring the headshot of MD+DI Senior Editor Amanda Pedersen and a pull quote from the latest edition of her opinion column.
The EU AI Act: How Will It Impact Medical Device Manufacturers?Feb 27, 2024|8 Min Read
BioSig's Ridiculously Sparse Layoff Announcement Reeks of CallousnessFeb 26, 2024|3 Min Read
Sourcing Electrical Components: Are We Back to Normal?Feb 26, 2024|6 Min Read
Your Smartwatch Can’t Measure Blood Glucose Levels… YetFeb 26, 2024|3 Min Read