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Devices Cardiology

 News Release - May 22, 2014

Preliminary Results From the St. Jude Medical EnligHTN III Study Demonstrate Renal Denervation Is Safe and Effective

Results from the EnligHTN I, II and III trials presented during EuroPCR add to the growing body of clinical evidence supporting the benefits of EnligHTN renal denervation technologies

ST. PAUL, Minn. & PARIS--(Healthcare Sales & Marketing Network)--St. Jude Medical, Inc. (STJ), a global medical device company, today announced preliminary results from the EnligHTN III study, which found the company’s second-generation EnligHTN™ renal denervation system provided safe and effective therapy for patients with drug-resistant, uncontrolled hypertension six months post-procedure. The results were presented during a hot line late-breaking clinical trial session at EuroPCR 2014.

The EnligHTN III study is an international, non-randomized clinical trial that followed device performance and assessed outcomes through six months of follow-up for 39 eligible patients. Preliminary results confirmed safe, rapid and sustained reduction in blood pressure measurements for patients with drug-resistant hypertension, meaning their high blood pressure could not be controlled through medication.

“This six-month data from EnligHTN III provides further evidence of the benefits associated with this next-generation renal denervation system,” said Prof. Stephen Worthley of St. Andrew's Hospital in Adelaide, Australia, a principal investigator of the EnligHTN III study. “This study demonstrates that the next-generation EnligHTN renal denervation system delivers safe and effective treatment that is aligned with the outcomes of the first generation system, and ultimately saves time in the procedure room.”

Six-month EnligHTN III data showed:

  • An average systolic blood pressure reduction of 25 mmHg points
  • 81 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
  • No serious device- or procedure-related adverse events reported

EnligHTN I and EnligHTN II Data

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. New data from the EnligHTN I trial, 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.

Also presented at EuroPCR were one-month findings from the post-market EnligHTN II clinical trial. Preliminary results demonstrated a reduction in systolic blood pressure across sub-groups with varying degrees of hypertension and kidney functionality, and found an early 14 mmHg reduction in blood pressure in patients with a systolic blood pressure above 160 mmHg. Blood pressure reduction for patients with a systolic blood pressure above 160 mmHg was in-line with previous real-world, post market studies. While still reporting a reduction, patients with poor kidney functionality and a baseline blood pressure lower than 160 mmHg did not have as large of a reduction of blood pressure at one month.

The EnligHTN II trial is being conducted at up to 40 sites in Europe and Australia and will enroll up to 500 patients with uncontrolled hypertension. The data presented during EuroPCR was from 18 centers and 100 patients.

Collectively, the EnligHTN trials are approaching 300 treated patients with ongoing enrollments in the EnligHTN II trial and observational registries across Europe and Australia.

“St. Jude Medical is encouraged by the positive clinical results we’re seeing from our renal denervation studies,” said Dr. Mark D. Carlson, chief medical officer for St. Jude Medical. “We have a long history of advancements in ablation technologies and have used our internal product development capabilities to optimize our multi-electrode renal denervation technology. We believe this therapy has the potential to dramatically improve the lives of millions of patients with severe high blood pressure and will continue to invest in renal denervation as a potential long-term growth driver.”

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 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 next-generation EnligHTN system offers physicians a multi-electrode catheter with an intuitive, faster generator that quickly and effectively delivers consistent ablations with a significant reduction in procedure time.

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.

To learn more about renal denervation or see a demo of the next-generation EnligHTN Multi-Electrode Renal Denervation System, EuroPCR attendees can visit St. Jude Medical at booth F16.

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 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 March 29, 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.

Source: St. Jude Medical

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