St. Jude Medical, Inc., a global medical device company, announced CE Mark Approval and launch of its EnligHTNâ„ renal denervation system during EuroPCR. Renal denervation is a specialised ablation procedure that has been clinically proven to reduce blood pressure in patients with hypertension, or high blood pressure, that is resistant to medical therapy. Clinical data from the EnligHTN I trial about the safety and efficacy of the companys renal denervation technology will be presented.
Hypertension is a root cause of a variety of life-threatening health problems, including heart disease, stroke, and kidney failure. It impacts more than 1 billion people globally at an estimated cost of $500 billion annually. About 25 percent of patients with hypertension do not respond adequately to con-ventional treatment with medication.
Using the EnligHTN system, an ablation catheter delivers radio frequency (RF) energy to create lesions (tiny scars)along the renal sympathetic nerves “ a network of nerves that help to regulate pressure; the intentional disruption of the nerve supply has been clinically found to decrease systolic blood pressure. This is important because the risk of cardiovascular death is cut in half with every 20 point decrease in systolic blood pressure.
The system is the industrys first multi-electrode ablation technology for renal denervation.With the unique basket design, each placement of the ablation catheter allows a consistent and predictable pattern of four ablations in 90-second intervals.Compared to single electrode ablations, the multi-electrode EnligHTN system has the potential to improve consistency and procedural reliability, save time as well as result in workflow and cost efficiencies.Additionally,the minimal catheter repositioning may result in a reduction of contrast and fluoroscopic (x-ray) exposure.
The technology includes a guiding catheter, ablation catheter and ablation generator. The generator uses a proprietary, temperature-controlled algorithm to deliver effective therapy.