Twelve-Month Data from St. Jude Medical EnligHTN Renal Denervation System Show Continued Safety and Efficacy for Patients

St. Jude Medical presents data for patients with drug-resistant uncontrolled hypertension at TCT 2014

EnligHTN Renal Denervation System Illustration. Courtesy of St. Jude Medical. (Graphic: Business Wire)

TCT 2014

ST. PAUL, Minn.--()--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced 12-month outcome data from the EnligHTN III study, which demonstrated a continuation of safe, rapid and effective treatment with the next-generation EnligHTN Renal Denervation System for patients with drug-resistant, uncontrolled hypertension. The results were presented during the 26th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

Renal denervation is a specialized ablation procedure that has demonstrated a reduction in blood pressure for patients with hypertension, or high blood pressure, that is resistant to medical therapy. 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 found to help reduce systolic and diastolic blood pressure. The system catheter has a unique, non-occlusive basket design with multiple electrodes, which help physicians deliver a predictable treatment pattern while allowing for continuous blood flow to the kidney throughout the procedure. The next-generation EnligHTN system, CE Mark approved in 2013, delivers simultaneous ablations via a multi-electrode catheter, reducing total ablation time by more than 80 percent in comparison to the first generation system, from approximately 24 minutes to four minutes.

“The twelve-month data for EnligHTN III continues to show the benefits of the EnligHTN Renal Denervation System and merits for its potential to change the way hypertension is treated,” said Prof. Stephen Worthley of St. Andrew's Hospital in Adelaide, Australia, a principal investigator of the EnligHTN III study. “These data continue to demonstrate that the multi-electrode system from St. Jude Medical provides a safe and effective alternative for patients with drug-resistant and uncontrolled hypertension.”

The EnligHTN III study is an international, non-randomized clinical trial that followed device performance and assessed outcomes at six centers through twelve months of follow-up for 37 eligible patients.

Twelve-month EnligHTN III data showed:

  • An average office systolic blood pressure reduction of 23 mmHg points
  • An average ambulatory systolic blood pressure reduction of 10 mmHg points
  • 78 percent of patients responded to the therapy, which is defined as a blood pressure reduction of at least 10 mmHg when measured during an office visit

“We are pleased with the progress of our EnligHTN Renal Denervation program,” said Dr. Mark D. Carlson, chief medical officer for St. Jude Medical. “Our innovative EnligHTN technology with its multiple electrode basket design allows for consistent lesion creation that we believe minimizes variability during the procedure.”

To learn more about renal denervation or see a demo of the next-generation EnligHTN Multi-Electrode Renal Denervation System, TCT attendees can visit St. Jude Medical at booth #1100.

The EnligHTN III study expands upon the research conducted in the EnligHTN I trial of the first-generation EnligHTN system, which demonstrated that patients with drug-resistant hypertension had a safe drop in blood pressure.

About EnligHTN I

New data from the EnligHTN I trial, which was presented at EuroPCR 2014, confirmed the fast, early reduction in blood pressure remains sustained at 24 months, further demonstrating the long-term benefits of this procedure when using the EnligHTN technology. 77 percent of patients were responders at 24 months, with a blood pressure reduction of at least 10 mmHg.

Forty-six patients were treated with the EnligHTN system in the EnligHTN I multicenter study. To be considered for enrollment, patients were required to have a systolic blood pressure above 160 mmHg (150 mmHg for patients with type II diabetes) and take at least three antihypertensive medications, including a diuretic. Notably, the EnligHTN I study reports the longest term follow-up to date on a multi-electrode ablation catheter.

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.

One of the key risk factors for cardiovascular disease is hypertension or “high blood pressure.”

Hypertension already affects one billion people worldwide, leading to heart attacks and strokes.

Researchers have estimated that raised blood pressure currently kills nine million people every year, 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.

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 or follow us on Twitter @SJM_Media.

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 28, 2013 and Quarterly Report on Form 10-Q for the fiscal quarter ended June 28, 2014. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Contacts

St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
jweigelt@sjm.com
or
Media Relations
Kristi Warner, 651-756-2085
kwarner@sjm.com

Release Summary

St. Jude Medical's EnligHTN III study showed safe, rapid and effective treatment with the next-generation EnligHTN™ Renal Denervation System for patients with drug-resistent uncontrolled hypertension

Contacts

St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
jweigelt@sjm.com
or
Media Relations
Kristi Warner, 651-756-2085
kwarner@sjm.com