St. Jude Medical Receives European Approval for New Renal Denervation System That Reduces Total Ablation Time by More Than 80 Percent
ST. PAUL, Minn.--(BUSINESS WIRE)-- St. Jude Medical, Inc. (STJ), a global medical device company, today announced the CE Mark approval of its next-generation EnligHTN™ Renal Denervation System for treating patients with drug-resistant, uncontrolled hypertension. The system features an advanced generator that delivers simultaneous ablations via a multi-electrode catheter, reducing total ablation time with the new EnligHTN system by more than 80 percent in comparison to the first generation system, from approximately 24 minutes to four minutes. The EnligHTN system will be on display during the 2013 European Society of Cardiology (ESC) meeting from August 31 to September 3.
“The new EnligHTN system improves the procedure by significantly reducing ablation time and providing optimized ablation monitoring feedback,” said Thomas Lüscher, professor and chairman of Cardiology, at the Cardiovascular Center at the University Hospital in Zurich and editor in chief of the European Heart Journal. “Renal denervation is a relatively simple, minimally-invasive procedure that is emerging as an important new avenue for managing hypertensive patients who do not respond to medications.”
Renal denervation is a catheter-based ablation procedure used to treat patients with drug-resistant hypertension (high blood pressure). The EnligHTN system delivers radiofrequency (RF) energy from an ablation catheter to create lesions (tiny scars) along the renal nerves – a network of nerves in the walls of the renal arteries thought to help control blood pressure. The intentional disruption of the nerve supply has been clinically found to help reduce systolic and diastolic blood pressure. The system catheter has a unique, non-occlusive basket design, helping physicians deliver a predictable treatment pattern while allowing for continuous blood flow to the kidney throughout the procedure.
Blood pressure reduction is quickly achieved by simultaneously administering 60 second ablations from all four catheter electrodes, which is typically performed two times in each renal artery. The advanced generator also has an icon-based touch screen interface that allows physicians to easily view and record procedure information.
“The next generation EnligHTN system offers physicians our proven multi-electrode catheter with a new intuitive, faster generator that quickly and effectively delivers consistent ablations with a significant reduction in procedure time,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “These advancements deliver on our strategy to bring new innovations to a developing market to provide options for patients who currently do not have an adequate treatment for their uncontrolled drug-resistant hypertension.”
Renal denervation represents an important area of research. St. Jude Medical is conducting five renal denervation studies including the EnligHTNment landmark trial. This study is the first large-scale trial that will examine the long-term effects of renal denervation to see if the therapy also reduces the risk of heart attack, stroke, heart failure requiring hospitalization, as well as cardiovascular death in patients with uncontrolled hypertension.
The next-generation EnligHTN system is currently being evaluated in the EnligHTN III study, an international, non-randomized clinical trial that will enroll up to 50 patients in Australia and New Zealand. This study expands on EnligHTN I trial research of the first generation EnligHTN system, which demonstrated that patients with drug-resistant hypertension had a safe, rapid and sustained drop in blood pressure. After thirty days, systolic blood pressure was reduced by an average of 28 mmHg (millimeters of mercury) that remained stable with a reduction of 27 mmHg points one year after treatment.
About Hypertension
A normal blood pressure is typically at or below 120 systolic and 80 diastolic, expressed as 120/80 mmHg. Hypertension is categorized as a blood pressure reading greater than 140/90 mmHg. Lowering hypertension is important as the risk of cardiovascular death doubles with every 20 point increase in systolic blood pressure.
Hypertension or “high blood pressure” is a common medical condition that can cause life-threatening health problems such as heart disease, stroke or kidney failure that affects one in three adults worldwide according to the World Health Organization (WHO). Known as the “silent killer,” high blood pressure often presents no warning signs or symptoms and many people do not realize they have it. Drug-resistant hypertension is a condition that cannot be controlled through medication. There are more than 100 million people worldwide that are treatment resistant where at least three high blood pressure drugs do not work. The annual global health care expenditure directly related to hypertension is estimated at almost 385 billion Euros every year.
Recently, the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) issued guidelines recommending the use of catheter-based renal denervation for the treatment of high blood pressure in patients with difficult-to-treat, drug-resistant hypertension.
To learn more about renal denervation or see a demo of the next-generation EnligHTN Renal Denervation System, ESC attendees can visit St. Jude Medical at booth C310 of Exhibition Hall 1.
In 2012, the first-generation EnligHTN Renal Denervation System earned European CE Mark approval and was launched in several markets. The EnligHTN systems are not approved for use in the U.S.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive, epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul Minn., St. Jude Medical has four major clinical 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 29, 2012 and Quarterly Report on Form 10-Q for the fiscal quarter ended June 29, 2013. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
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Contact:
St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
jweigelt@sjm.com
or
Denise Landry, 972-309-8085
U.S. Media Relations
dlandry@sjm.com
or
Marisa Bluestone, 651-756-6739
International Media Relations
mbluestone@sjm.com
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