St. Jude Medical Gains CE Mark Approval for the Enlightn Renal Denervation System

May 15, 2012—St. Jude Medical, Inc. (St. Paul, MN), announced CE Mark approval and the European launch of its Enlightn renal denervation system at the EuroPCR 2012 conference in Paris.

In the same press release, the company advised that clinical data from the ARSENAL trial of the safety and efficacy of the Enlightn renal denervation technology for the treatment of resistant hypertension were presented on May 16 at EuroPCR by the study's Principal Investigator Prof. Stephen Worthley, MD, from Royal Adelaide Hospital in Australia.

Commenting in the St. Jude press release, Prof. Worthley said, “In my experience, the Enlightn renal denervation system has been successful in reducing blood pressure in patients with resistant hypertension. 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.”

St. Jude's multi-electrode Enlightn system features a basket design, with each placement of the ablation catheter allowing a consistent and predictable pattern of four ablations in 90-second intervals. The technology includes a guiding catheter, ablation catheter, and ablation generator. The generator uses the company's temperature-controlled algorithm to deliver effective therapy, stated the company's announcement.

After Prof. Worthley's presentation of the preliminary data from ARSENAL, St. Jude Medical announced that the study demonstrated the safety and effectiveness of the Enlightn system.

According to the company's press release, patients with resistant hypertension who were treated with Enlightn experienced a systolic blood pressure reduction of 28 points on average after 30 days. Further, the treatment was successfully delivered with no serious complications related to the procedure or device.

As detailed by St. Jude Medical, 47 patients were enrolled in the multicenter ARSENAL study. To be considered for enrollment, patients were required to have a systolic blood pressure >160 (150 for patients with type 2 diabetes) and take at least three antihypertensive medications concurrently at maximally tolerated doses, including a diuretic. Patients who enrolled in the trial had an average baseline blood pressure of 176/96 mm Hg, despite being on multiple medications to help control blood pressure. 

In its statement, the company advised that the results after 30 days demonstrated an average blood pressure of 148/87 mm Hg, which is a 28-point reduction from the systolic pressure of 176 mm Hg at baseline. In 41% of patients, there was a reduction in systolic blood pressure to < 140 mm Hg.

In St. Jude's press release, Prof. Worthley commented, “The risk of cardiovascular death doubles with every 20-point increase in systolic blood pressure, so an average blood pressure reduction of 28 points is quite significant and demonstrates just how effective the technology is. From other clinical trials studying the impact of renal denervation, we have learned that blood pressure continues to be reduced over time, so I would not be surprised to see this trend continue and see an even greater benefit for patients.”