Significant Blood Pressure Reduction from St. Jude Medical's EnligHTN Renal Denervation Technology i
Significant Blood Pressure Reduction from St. Jude Medical's EnligHTN Renal Denervation Technology is Safe, Effective and Sustained at Six Months
Data from multi-electrode renal denervation catheter study presented today at the annual scientific meeting of the American Heart Association
ST. PAUL, Minn.--(BUSINESS WIRE)-- St. Jude Medical, Inc. (NYS: STJ) , a global medical device company, today announced that the company's EnligHTN™ renal denervation system provided a safe, effective and sustained reduction in office and ambulatory blood pressure measurements at six months. The new data was released in the Clinical Science and Special Reports Session during the annual American Heart Association (AHA) meeting.
Renal denervation is a minimally invasive approach for the treatment of patients with drug-resistant hypertension. It is a specialized ablation procedure that targets nerves in the renal arteries leading to the kidneys that has been clinically proven to reduce blood pressure. A typical normal blood pressure is below 120 systolic (the first number) and 80 diastolic (the second number) and is expressed as 120 / 80 mmHg. Hypertension, or high blood pressure, is a 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.
Patients enrolled in the EnligHTN I study had an average blood pressure of 176 / 96 mmHg despite being treated with multiple medications to manage this condition. Those treated with the EnligHTN renal denervation system experienced an average rapid systolic blood pressure reduction of 28 mmHg points after 30 days.
At six months:
- An average systolic blood pressure reduction of 26 mmHg points was maintained
- 76 percent of patients responded to the therapy and had an average office blood pressure of 150 / 86 mmHg
- There were no serious acute device- or therapy-specific adverse events reported
"Managing blood pressure is a critical factor in maintaining the overall cardiovascular health of patients with drug-resistant hypertension," said Dr. Vasilios Papademetriou, clinical associate-scientific collaborator from First Cardiology Clinic at Hippokration Hospital in Athens, Greece, and a coordinating study investigator who presented the data at the AHA meeting. "These results are important as they show that use of the EnligHTN multi-electrode renal denervation system can rapidly and safely decrease blood pressure, and the reduction is sustainable over time."
A prospective, multi-center feasibility study, the EnligHTN I trial treated 46 patients whose blood pressure remained resistant despite being on three antihypertensive medications and a diuretic. To be considered for the study, patients were required to have a systolic blood pressure greater than or equal to 160 mmHg (150 mmHg for patients with type 2 diabetes).
"Renal denervation represents an important area of research in the management of hypertension for the millions of patients who live with this life-threatening condition," said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. "We are pleased with the rapid and sustained reduction of blood pressure to date and remain committed to advancing the science, technology and clinical evidence surrounding this important new procedure."
About Renal Denervation and the EnligHTN System
The EnligHTN system is a multi-electrode ablation technology for renal denervation. Using the new 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 control blood pressure; the intentional disruption of the nerve supply has been clinically found to cause systolic and diastolic blood pressure to decrease.
With its unique basket design, each placement of the ablation catheter administers a predictable treatment pattern. The non-occlusive basket design allows for continuous blood flow to the kidney during the procedure. Compared to single-electrode ablation systems, the four-point contact of the multi-electrode EnligHTN system has the potential to improve consistency, save time as well as result in workflow and cost efficiencies.
The technology 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.
The EnligHTN Renal Denervation System earned European CE Mark approval and launched this year in several markets. It is not approved for use in the U.S.
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 31, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 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.
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