The company is developing the Peregrine System, an infusion catheter that delivers diagnostic and therapeutic agents to the perivascular space surrounding blood vessels. The 510(k)-cleared device includes three microneedles that remain within radiopaque guide tubes prior to drug delivery. After the device is positioned, the microneedles are deployed simultaneously, according to Ablative.
The company won FDA approval for a Phase II trial of its Peregrine system in patients with hypertension in September of 2016.
Ablative reported that its 100-patient trial planned to use the infusion ablation system to interrupt signals from sympathetic nerves in the renal artery to control hypertension.
Traditional renal denervation makes use of radiofrequency to silence sympathetic nerves, which can be extremely painful. But Ablative’s system causes minimal discomfort to patients, according to the company.
The drug-device combination therapy won CE Mark clearance in the European Union in May of 2015.