Feature | May 15, 2012

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

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

Related Content

transradial approach, same-day cardiac procedures, radial access, $300 million annual savings, JACC Cardiovascular Interventions study
News | Radial Access| February 22, 2017
If hospitals can perform more transradial, same-day percutaneous coronary intervention (PCI), hospitals across the U.S...
Technology | Radial Access| February 17, 2017
Medtronic plc announced that its coronary portfolio will now include the DxTerity Diagnostic Angiography Catheter line...
Sponsored Content | Videos | Inventory Management| February 17, 2017
The supplies you use in your cath lab are complex and very valuable.
Mercator MedSystems, DANCE trial data, ISET, LINC, Bullfrog Micro-Infusion Device
News | Peripheral Arterial Disease (PAD)| February 15, 2017
Mercator MedSystems announced that the national co-principal investigators of the company’s DANCE trial each presented...
Cardinal Health survey, hospital staff, supply chain management, quality of care
News | Inventory Management| February 15, 2017
Better hospital supply chain management leads to better quality of care and supports patient safety, according to a new...
University of Alabama at Birmingham, Amplatzer PFO Occluder, first implementation
News | Structural Heart Occluders| February 15, 2017
Doctors at the University of Alabama at Birmingham have implemented the first U.S. Food and Drug Administration (FDA)-...
Biotronik, PRO-Kinetic Energy cobalt chromium coronary stent system, FDA approval
Technology | Stents Bare Metal| February 15, 2017
The PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System from Biotronik has gained U.S. Food and Drug...
heart team, hybird OR, structural heart team

The heart team approach was first used on a large scale in the CoreValve and Sapien TAVR trials and helped lead to excellent outcomes in high-risk patients.

Feature | Hybrid OR| February 15, 2017 | Dave Fornell
In the current era of healthcare reform and the push toward evidence-based medicine to both lower costs and improve p
HeartFlow FFRct Analysis, NICE guidance, U.K., United Kingdom, guidelines, stable chest pain
News | CT Angiography (CTA)| February 14, 2017
The National Institute for Health and Care Excellence (NICE) in the United Kingdom recently issued guidance for use of...
News | Hypertension| February 13, 2017
Vascular Dynamics Inc. (VDI) announced that the U.S. Food and Drug Administration (FDA) has approved the company’s...
Overlay Init