St Jude Medical has announced positive results from a six month clinical study of its multi-electrode renal denervation technology, designed to treat patients with drug-resistant hypertension.
The CE-marked EnligHTN renal denervation system, which features a non-occlusive basket design, includes a guiding catheter, ablation catheter and ablation generator.
Using the minimally invasive ablation device, the catheter delivers radiofrequency energy to create lesions along the renal sympathetic nerves, that help control blood pressure.
In addition, minimal catheter repositioning may result in a reduction of contrast and fluoroscopic (x-ray) exposure, according to the company.
The multi-centre trial, which enrolled patients whose blood pressure remained resistant despite being on three antihypertensive medications and a diuretic, proved that the device is safe and effective at six months.
The study also maintained an average systolic blood pressure reduction of 26mmHg points, while 76% of patients responded to the therapy and had an average office blood pressure of 150/ 86mmHg.
Hippokration Hospital clinical associate-scientific collaborator and study coordinating investigator Dr Vasilios Papademetriou said managing blood pressure is a critical factor in maintaining the overall cardiovascular health of patients with drug-resistant hypertension.
"These results are important as they show that use of the EnligHTN multi-electrode renal denervation system can rapidly and safely decrease blood pressure, and the reduction is sustainable over time," Papademetriou said.
St Jude medical cardiovascular and ablation technologies division president Frank Callaghan said; "We are pleased with the rapid and sustained reduction of blood pressure to date and remain committed to advancing the science, technology and clinical evidence surrounding this important new procedure."
