Feature | February 13, 2013

St. Jude Medical Announces First Patient Enrollment in EnligHTN II Renal Denervation Study

Company expands evaluation of EnligHTN renal denervation technology for hypertension to new patient populations

St. Jude Medical EnligHTN II trial Renal Denervation System

February 13, 2013 — St. Jude Medical Inc. announced enrollment of the first patient in the EnligHTN II trial. This post-market clinical study will further evaluate the safety and efficacy of the EnligHTN renal denervation system in patients with uncontrolled hypertension

The EnligHTN II (IntErnational non-randomized, single-arm, long-term follow-up study of patients with uncontrolled HyperTensioN) trial expands upon the research conducted in the EnligHTN I trial, which demonstrated that patients with drug-resistant hypertension treated with the St. Jude Medical EnligHTN system had a rapid and sustained drop in blood pressure. After thirty days, systolic blood pressure was reduced by an average of 28 mmHg that remained stable with a reduction of 26 mmHg points six months after treatment, an important finding as the risk of cardiovascular death drops by half with every systolic decrease of 20 mmHg.

“There is convincing evidence from studies like the EnligHTN I trial linking renal denervation to improved blood pressure in patients who have drug-resistant hypertension,” said Dr. Johannes Brachmann at Klinikum Coburg in Coburg, Germany. “Expanding this research to patients with less severe forms of hypertension is important as this minimally invasive approach allows for a shorter procedure time and a potentially faster recovery time, which may benefit more patients with uncontrolled hypertension.”

Hypertension occurs when blood pressure in the arteries is elevated, requiring the heart to work harder than normal to circulate blood throughout the body. A typical normal blood pressure reading is below 120 systolic and 80 diastolic — expressed as 120/80 mmHg. To date, the majority of renal denervation studies have only tested the safety and efficacy of this technology in patients with drug-resistant hypertension, which is defined as systolic blood pressure above 160 mmHg, despite being on three or more anti-hypertensive medications including a diuretic.

The EnligHTN II study aims to broaden this scope by evaluating the mean reduction in systolic blood pressure at six months across all enrolled patients post renal denervation and within sub-groups with varying degrees of kidney functionality. The study will be conducted at 40 sites in Europe and Australia and will enroll approximately 500 patients with uncontrolled hypertension.

“St. Jude Medical is dedicated to conducting research that will contribute to the body of evidence supporting the effectiveness of renal denervation in reducing hypertension,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “Through the course of the EnligHTN II study, we expect to gain additional insights into the benefits and sustainability of blood pressure reductions achieved through use of the EnligHTN Renal Denervation System in an expanded patient population.”

According to the World Health Organization (WHO), one in three adults worldwide has elevated blood pressure — a condition that increases the risk of heart attack, stroke and kidney failure.

For more information: www.sjm.com

Related Content

TOBA-BTK study, twelve-month results, SCAI 2016, Tack Endovascular System, critical limb ischemia
News | Peripheral Arterial Disease (PAD)| May 05, 2016
Intact Vascular Inc. announced that positive twelve-month results from its Tack Optimized Balloon Angioplasty – Below-...
SCAI, cath lab, best practices, guidelines, 2016
News | Cath Lab| May 05, 2016
May 5, 2016 — The Society for Cardiovascular Angiography and Interventions (SCAI) published an update to its 2012 pap
FDA, CDRH, national evaluation system, medical device development
Feature | Business| May 04, 2016
The U.S. Food and Drug Administration (FDA) announced it is building the foundations of a national evaluation system to...
radiation dose in the cath lab
News | Radiation Dose Management| May 02, 2016
May 2, 2016 — Starting at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 annual meeting May
microtubules, heartbeat mechanics, Perelman School of Medicine study

Microtubules in a cardiomyocyte at rest (top) and when compressed. Image courtesy of the lab of Ben Prosser, Ph.D., Perelman School of Medicine, University of Pennsylvania

News | EP Lab| April 29, 2016
Using new high-resolution microscopy, researchers have found that molecular struts called microtubules (MT) interact...
breast cancer, herceptin chemotherapy drug, heart damage, monitoring, Journal of Clinical Oncology study
News | Cardiac Diagnostics| April 28, 2016
April 28, 2016 — Breast cancer patients undergoing treatment with trastuzumab-containing regimens should be monitored
Feature | Business| April 28, 2016 | Dave Fornell
 
Technology | Stents Peripheral| April 27, 2016
Veniti Inc. announced the first successful treatment with the Vici Verto Venous Stent System of a patient suffering...
coronary CT angiography, CCTA, SCOT-HEART trial substudy, SCCT
News | Computed Tomography (CT)| April 26, 2016
The results of a secondary analysis of the SCOT-HEART trial show that coronary computed tomography angiography (CCTA)...
sleep patterns, metabolic syndrome, risk factors, ACC study
News | Cardiac Diagnostics| April 26, 2016
Taking long naps or being excessively tired during the day is associated with a higher risk for developing metabolic...
Overlay Init