Ablative Solutions announced today that its TARGET BP I pivotal trial evaluating its Peregrine System kit met its primary endpoint.
The trial evaluates alcohol-mediated renal denervation to treat hypertension with the Peregrine System. Wakefield, Massachusetts-based Ablative Solutions reported a statistically significant difference in 24-hour ambulatory blood pressure between treatment and sham procedure at three months.
TARGET BP I evaluated the safety and efficacy of Peregrine to treat uncontrolled hypertension in patients taking anti-hypertensive medications. It evaluated 301 patients randomized to Peregrine treatment or sham procedure. The study remained blinded through six months follow-up.
The kit features a patented infusion catheter and dehydrated alcohol. Patients undergo a minimally invasive procedure to ablate the sympathetic nerves surrounding the renal arteries, reducing blood pressure.
Renal denervation has become a hot topic of late with the first FDA nods recently coming for the hypertension treatment method. Recor Medical won the race as its Paradise ultrasound renal denervation system cleared the regulatory hurdle on Nov. 8. Medtronic’s RF-based Symplicity Spyral followed soon after, garnering approval on Nov. 17.
The Ablative Solutions investigational alcohol-mediated renal denervation option could offer another hypertension treatment option. Dr. David Kandzari, co-principal investigator of TARGET BP I, expects data in the coming months. Kandzari also served as the lead principal investigator in Medtronic’s key Symplicity Spyral clinical trial. He performed the first commercial procedure with the system late last month.
“We are excited to have achieved this significant milestone in the company’s history,” said Kate Rumrill, president and CEO of Ablative Solutions. “We are grateful to our physician advisors, study investigators and coordinators, and company employees for their contributions in the delivery of these important data.”