St Jude Medical Launches EnligHTN Renal Denervation System

St Jude Medical Launches EnligHTN Renal Denervation System

St. Jude Medical Announces European Approval and Launch of the EnligHTN Renal Denervation System for Treatment of Hypertension

Decades of experience in ablation technologies used to develop the industry’s first multi-electrode technology for renal denervation

ST. PAUL, Minn. & PARIS–(BUSINESS WIRE)–May. 15, 2012– St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today 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 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.

“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.”

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 8:00 in room 242A. The study, led by Prof. Worthley, is expected to demonstrate the safety and efficacy of the system in the treatment of patients with treatment-resistant hypertension.

A St. Jude Medical-sponsored tools and techniques session about renal denervation entitled A Practical Guide to EnligHTN Renal Denervation: a New Approach for the Treatment of Resistant Hypertension will take place Wednesday, May 16 beginning at 12:00 in Room Maillot. The session will include lectures on a variety of topics, including the role the renal nerves play in hypertension maintenance and how to set up a renal denervation practice as well as a pre-recorded live demonstration.

Attendees can visit St. Jude Medical at booth F8 and F9 found on Level 1 of the exhibition hall during EuroPCR to see the EnligHTN renal denervation system or visit SJMenligHTN.com.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2012. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

A Breakthrough Technology on Many Points

The EnligHTN™ multi-electrode renal denervation system enables cutting-edge efficiencies in procedural-based hypertension control by reducing the number of catheter manipulations needed to disrupt the sympathetic nerve network — with speed and placement accuracy.1-3 Renal denervation has been demonstrated to effectively reduce systolic blood pressure.4

Fast

EnligHTN administers a predictable pattern of four ablations with each placement — in 90-second intervals — potentially reducing renal denervation procedure time.2,3

Efficient

Unique multi-ablation basket design provides four ablations without readjustment.

Precise

Consistent, four-point contact with arterial wall designed to increase procedural accuracy.

Minimized Exposure

Minimal catheter repositioning may result in shorter procedure time, reduced contrast and fluoroscopic exposure.*

Your Partner in Renal Denervation Treatment

The EnligHTN renal denervation system offers advanced renal artery ablation therapy and is designed to deliver radiofrequency (RF) energy to the renal nerves to achieve targeted denervation. The core system components are the EnligHTN™ RF ablation generator, the EnligHTN™ renal artery ablation catheter and the EnligHTN™ guiding catheter.

It seems that renal denervation systems are popping up like daisies these days. Today at the EuroPCR meeting in Paris, France, St. Jude Medical announced CE Mark Approval and the launch of its EnligHTN renal denervation system. Like other renal ablative systems, this one is approved to reduce blood pressure in patients with hypertension resistant to medical therapy.

Similar to the Vessix Vascular V2 system, the EnligHTN has multiple electrodes which potentially saves time during the ablation procedure, as four ablations can be performed without catheter repositioning.

From the press release:

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.

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.

St. Jude Medical will be presenting clinical data from the EnligHTN I trial about the safety and efficacy of the system at EuroPCR on Wednesday.

Update: This story previously stated incorrectly that the EnligHTN is uniquely the only approved renal denervation system with multiple electrodes.

Source : http://investors.sjm.com/phoenix.zhtml?c=73836&p=irol-newsArticle&ID=1695802

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