ST. PAUL, Minn. & PARIS--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that the company’s EnligHTN™ Multi-Electrode Renal Denervation System provides a safe, rapid and sustained reduction in blood pressure measurements after one year. The new one year study data from the EnligHTN I trial was presented today at EuroPCR 2013 in Paris.
Renal denervation is a minimally invasive, catheter-based ablation procedure used to treat patients with drug-resistant hypertension (or high blood pressure). A series of radiofrequency (RF) energy ablations are administered to create lesions (tiny scars) along the renal sympathetic nerves – a network of nerves that help control blood pressure. Typically, normal blood pressure is at or below 120 systolic and 80 diastolic, which is expressed as 120 / 80 mmHg. Hypertension is categorized as a blood pressure reading greater than 140 / 90 mmHg. It is important to note that the risk of cardiovascular death is cut in half with every 20 mmHg decrease in systolic blood pressure.
Patients enrolled in the EnligHTN I trial had an average blood pressure of 176 / 96 mmHg and patients were drug-resistant, meaning their blood pressure could not be controlled through medication. At one year, patients treated with the EnligHTN Renal Denervation System experienced an average systolic blood pressure reduction of 27 mmHg points when measured in an office setting.
One Year Study Findings:
- An average systolic blood pressure reduction of 27 mmHg points was reported
- 80 percent of patients responded to the therapy defined as a blood pressure reduction of at least 10 mmHg when measured during an office visit
- The longer-term safety profile for renal denervation was supported by showing no significant changes in kidney function
“Hypertension can be difficult to treat and the need for additional options is great considering the growing number of patients with high blood pressure who are at risk for heart attack, stroke and death,” said Prof. Stephen Worthley of the Royal Adelaide Hospital in Australia. Dr. Worthley, a primary investigator of the EnligHTN I trial, delivered the study’s one-year findings during a presentation at EuroPCR. “The results of the EnligHTN I study confirm that the early significant reduction in blood pressure is sustained through 12 months, but as important are the favorable renal effects as evidenced by an improvement in some kidney markers. Renal denervation has tremendous potential for patients with severe hypertension who are not responding to medication.”
A prospective, multi-center feasibility study, the EnligHTN I trial treated 46 patients whose blood pressure was considered drug resistant despite taking three or more antihypertensive medications including a diuretic. To qualify for the study, patients had a systolic blood pressure greater than or equal to 160 mmHg (150 mmHg for patients with type 2 diabetes). Patients in the trial will continue to be followed for a total of two years post procedure.
“The one year results of the EnligHTN I trial are important as they further substantiate that blood pressure can safely and effectively be reduced with the EnligHTN Renal Denervation System in this challenging patient population,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “We are pleased that the study continues to report a sustained reduction in hypertension, potentially providing a long-term benefit for patients whose lives are impacted by this difficult-to-treat condition.”
According to the World Heart Federation, one billion people globally have high blood pressure which occurs when blood pressure in the arteries is elevated, requiring the heart to work harder to circulate blood throughout the body. Hypertension is referred to as a “silent killer” because it presents no warning signs or symptoms and oftentimes people do not realize they have it.
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.
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. Key findings found a safe, rapid and sustained drop in blood pressure with an average systolic blood pressure reduction of 27 mmHg points 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 new, second 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 is expected to start in the second half of 2013. This study will be conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA).
- 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 see if there is also a reduction in risk of major cardiovascular events such as heart attack, stroke, heart failure and cardiovascular death. Approximately 4,000 patients are being enrolled around the world at up to 150 sites.
About 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 a decrease in systolic and diastolic blood pressure.
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 procedural accuracy, 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.
In 2012, the EnligHTN Renal Denervation System earned European CE Mark approval and was launched in several markets. The system is not yet approved for use in the U.S.
To learn more about renal denervation or see a demo of the EnligHTN Renal Denervation System, EuroPCR attendees can visit St. Jude Medical at booth # F16 of the exhibition hall, or visit us on the web at: http://www.sjmprofessional.com/europcr.
EuroPCR is the official congress of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), a leading international course for interventional cardiovascular specialists.
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.
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 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.
