St. Jude Medical Initiates First US Clinical Study of the EnligHTN Renal Denervation System for Drug
St. Jude Medical Initiates First US Clinical Study of the EnligHTN Renal Denervation System for Drug-Resistant High Blood Pressure
ST. PAUL, Minn.--(BUSINESS WIRE)-- St. Jude Medical, Inc. (NYS: STJ) , a global medical device company, today announced U.S. Food and Drug Administration (FDA) approval to begin the EnligHTN IV Renal Denervation Study, the first U.S. trial using the EnligHTN™ Multi-Electrode Renal Denervation System to treat patients with drug-resistant high blood pressure.
It is estimated that one in three American adults has hypertension, often referred to as high blood pressure - a condition that increases the risk of heart attack, stroke and kidney failure. Hypertension occurs when blood pressure in the arteries is elevated, requiring the heart to work harder than normal to circulate blood throughout the body.
"Sub-optimal blood pressure control is the most common attributable risk for death worldwide," said Dr. William B. White, professor and chief of hypertension and clinical pharmacology in the Calhoun Cardiology Center at the University of Connecticut Health Center in Farmington and co-chair of the EnligHTN IV steering committee. "Despite the availability of several effective drugs, approximately 50 percent of patients have inadequately controlled blood pressure and eight to 12 percent are considered resistant to these medications. Renal denervation therapy may be an important advancement for these patients."
Renal denervation is a minimally invasive therapy that may provide a lasting reduction in blood pressure for patients with hypertension who are resistant to medications. It is a specialized ablation procedure that targets nerves along the renal arteries leading to the kidneys. This intentional disruption of the nerves may cause a decrease in systolic and diastolic blood pressure.
A typical normal blood pressure is at or below 120 systolic and 80 diastolic, and is expressed as 120 / 80 mmHg. Hypertension is blood pressure greater than 140 / 90 mmHg. The risk of cardiovascular death is cut in half with every 20 mmHg decrease in systolic blood pressure.
Dr. William Gray, an interventional cardiologist at Columbia University Medical Center in New York City and co-chair of the EnligHTN IV steering committee stated, "The EnligHTN Renal Denervation System has shown tremendous promise in clinical studies outside the United States. We look forward to participating in this important study that has the real potential to change medical practice."
The EnligHTN IV study is a randomized, single-blind, controlled, multi-center trial to demonstrate the safety and effectiveness of the EnligHTN Renal Denervation System in reducing systolic blood pressure when measured in an office setting. The study will enroll approximately 590 patients between the ages of 18 and 80 with an office systolic blood pressure of 160 mmHg or greater, who are taking three or more antihypertensive medications including a diuretic. Study patients will be enrolled at up to 80 sites in the U.S. and Canada.
"Researching the treatment of hypertension is one example of the ongoing investments St. Jude Medical is making to deliver high-quality, innovative products, such as the EnligHTN Renal Denervation System, which aim to reduce health care costs and improve patient outcomes," said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. "The EnligHTN IV study represents another important step in our commitment to advancing science, technology and clinical evidence that supports renal denervation for the millions of patients who live with uncontrolled high blood pressure."
St. Jude Medical Clinical Evidence for Renal Denervation
Renal denervation represents an important area of research in the management of hypertension for the estimated one billion people globally who live with this life-threatening condition. St. Jude Medical is currently conducting numerous renal denervation studies to add to the body of evidence supporting the potential of this new therapy.
- EnligHTN I Trial - A prospective, multi-center clinical study of 46 patients in Australia and Greece with drug-resistant hypertension treated using the St. Jude Medical EnligHTN Renal Denervation System. Results demonstrated a safe, rapid and sustained drop in blood pressure with an average systolic blood pressure reduction of 27 mmHg one year after treatment.
- EnligHTN II Trial - Designed to expand on EnligHTN I research, this observational study broadens the patient population to include those having less severe forms of hypertension, including sub-groups with varying degrees of kidney functionality. Enrollment began in January 2013 and will include 500 patients at 40 sites in Europe and Australia.
- EnligHTN III Trial - Announced in May 2013, the EnligHTN III trial is an international, non-randomized study evaluating the safety and performance of the next generation EnligHTN Renal Denervation System for patients with drug-resistant uncontrolled hypertension. New system advancements include simultaneous ablations with an intuitive touch screen generator which potentially enables faster procedure times for hypertension treatment. These features reduce the total ablation time from 24 minutes to four minutes. The study will enroll up to 50 patients at sites in Australia and New Zealand.
- EnligHTN IV Trial - The first U.S. based renal denervation study for St. Jude Medical, the EnligHTN IV trial will be conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) with the EnligHTN Multi-Electrode Renal Denervation System.
- EnligHTNment Trial - The EnligHTNment trial is the largest randomized, prospective clinical study ever conducted for renal denervation. The study is evaluating the long-term effects of using the EnligHTN system in patients with uncontrolled hypertension to study if there is also a reduction in risk of major cardiovascular events such as heart attack, stroke, heart failure hospitalizations and cardiovascular death. Approximately 4,000 patients are being enrolled around the world at up to 150 sites.
About the EnligHTN Renal Denervation System
The EnligHTN system is a multi-electrode ablation technology featuring a unique, non-occlusive basket design that delivers a predictable pattern of four evenly-spaced ablations with each catheter placement. This allows for continuous blood flow to the kidney during the procedure. Compared to single-electrode ablation systems, the multi-electrode EnligHTN system has the potential to improve consistency and save time, which may result in improved workflow and cost efficiencies.
The renal denervation system includes a guiding catheter, ablation catheter and ablation generator. The generator uses a proprietary, temperature-controlled algorithm to produce effective lesions. Additionally, minimal catheter repositioning may result in a reduction of contrast and fluoroscopic (X-ray) exposure.
In 2012, The EnligHTN Multi-Electrode Renal Denervation System earned European CE Mark approval and was launched in several markets. The EnligHTN IV trial is being conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA).
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.
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 March 30, 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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