European Approval And Launch Of St.Jude’s EnligHTN™ Renal Denervation System

In short

EuroPCR is being held in Paris right now and is the European focal point for all things cardiovascular. St. Jude Medical, Inc. has chosen the event to announce CE Mark Approval and launch of its EnligHTN™ renal denervation system for the treatment of resistant renal hypertension.

Background

As we’ve covered on an increasing number of occasions, renal denervation is becoming quite a hot topic. In short it 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. Companies are developing ever different means of delivering energy to the renal sympathetic nerves, from balloons to probes to the elaborate looking device pictured.

Clinical data from the EnligHTN I trial about the safety and efficacy of the St.Jude’s renal denervation technology will be presented at EuroPCR on Wednesday.

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 conventional treatment with medication.

Using the EnligHTN system, an ablation catheter delivers radiofrequency (RF) energy to create lesions 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.

Clinician comments

“In my experience, the EnligHTN renal denervation system has been successful in reducing blood pressure in patients with resistant hypertension,” said Prof. Stephen Worthley, the EnligHTN I trial’s Primary Investigator from Royal Adelaide Hospital in Australia. “The multi-electrode renal denervation system provides an efficient and effective alternative treatment for patients with resistant hypertension, and has the possibility to change the way that hypertension is treated.”

Company comments

“St. Jude Medical is focused on improving patient care while reducing the economic burden of epidemic diseases, and our groundbreaking EnligHTN renal denervation system is a great example of that focus,” said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. “This launch is important because it represents a significant growth opportunity and exemplifies our commitment to advancing the practice of medicine. We’ve applied the decades of insight we’ve gained from developing successful ablation technologies that treat cardiac arrhythmias to establish an innovative solution for hypertension.”

Source: St. Jude Medical Inc. Business Wire