St. Jude Medical Gains European Approval of EnligHTN Renal Denervation System to Treat Hypertension

 

May 15, 2012

May 15, 2012 – St. Jude Medical Inc. announced CE mark approval and launch of its EnligHTN renal denervation system during EuroPCR. 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. Clinical data from the EnligHTN I trial about the safety and efficacy of the company’s renal denervation technology will be presented 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.

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

Using the EnligHTN system, an ablation catheter delivers radiofrequency (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.

“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.”

The system is the industry’s 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.

Renal Denervation at EuroPCR

Data from the EnligHTN I (ARSENAL) trial, a prospective, multi-center study for the St. Jude Medical EnligHTN renal denervation system, will be presented during the session "Novel Approaches to Renal Denervation: Preclinical and First-In-Man Studies" on Wednesday, May 16 at 8 a.m.  The study, led by Worthley, is expected to demonstrate the safety and efficacy of the system in the treatment of patients with treatment-resistant hypertension.

For more information: www.sjm.com

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