St. Jude Medical Launches Renal Denervation System in Europe

St. Paul, Minn.-based St. Jude Medical has received CE Mark approval for the EnlighHTN renal denervation system for the treatment of hypertension, and will launch the product in Europe during EuroPCR, the official congress of the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

Renal denervation is a specialized 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. Ablation is the removal of body tissue, usually tissue that is dangerous to the body.

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. Clinical data from the EnligHTN I trial about the safety and efficacy of the company’s renal denervation technology will also be presented at EuroPCR, which will be held between May 15 and May 18.

“In my experience, the EnligHTN renal denervation system has been successful in reducing blood pressure in patients with resistant hypertension,” said Professor 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.”

The EnligHTN system uses an ablation catheter to deliver radiofrequency energy to create lesions along the renal sympathetic nerves, which is a network of nerves that help to regulate pressure. The deliberate disruption of the nerve supply has been clinically found to decrease systolic blood pressure, according to St. Jude. The risk of cardiovascular death is halved with every 20-point decrease in systolic blood pressure.

The ablation catheter is deisgned to allow a consistent and predictable pattern of four ablations in 90-second intervals at each placement. 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, claims St. Jude. The company also asserts that 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.

“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.”


St. Jude Medical is a medical device provider focused in cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.