EnligHTN™ renal denervation system optimized to deliver therapy for resistant hypertension

Portfolio Overview

  • Empowering physicians and patients with flexible, comprehensive solutions to manage uncontrolled, treatment-resistant hypertension
  • Transforming the treatment of resistant hypertension with breakthrough technology and therapies
  • Developing innovative, cost-effective therapies and tools that can potentially reduce the financial burden to hospitals
  • Delivering a rapid, significant and sustained reduction in blood pressure with cutting-edge renal denervation technology1
  • Designing products to reduce total ablation time in renal denervation procedures from 24 minutes to 4 minutes2,3


Fast Results for Resistant Hypertension

Patients often register a significant drop in blood pressure within 30 days of undergoing the renal denervation procedure with the EnligHTN™ system.1

Health care professional who specializes in treating patients with therapy-resistant hypertension

The Next Generation EnligHTNTM Renal Denervation System

As a physician who has frequent contact with patients suffering from therapy-resistant hypertension, you play an important role in identifying and treating individuals who may benefit from renal denervation. With the EnligHTN multi-electrode renal denervation system, you can offer a promising solution to patients unable to achieve safe blood pressure levels through a standard pharmacological regimen.

The EnligHTN system elevates the standard of patient care by leveraging the latest advances in cardiac ablation technology and applying them to the process of renal denervation. Developed through cutting-edge research in partnership with leading physicians worldwide, this flexible, cost-effective solution supports the effective treatment of patients suffering from uncontrolled hypertension.


A Promising Treatment

The role of the renal nerves in resistant hypertension

Catheter-based renal denervation offers you a promising treatment for resistant hypertension. Renal sympathetic nerves that surround the right and left renal arteries have been shown to play a role in regulating blood pressure. Patients with resistant hypertension have increased renal sympathetic nerve activity, which contributes to the pathophysiology of their hypertension.10-14 

The EnligHTNTM multi-electrode renal denervation system from St. Jude Medical delivers a predetermined, predictable ablation pattern to the renal artery using a single catheter, so you can offer patients with resistant hypertension an effective means for controlling high blood pressure.15 Minimal catheter manipulations minimize procedure time, and your patients should see fast results after a short recovery time. 

Drawing of implanted EnligHTN™ multi-electrode renal denervation system for hypertension management
Renal denervation clinical commitment key studies for EnligHTN I, EnligHTN II, and EnligHTN III

Proven Clinical Solutions

Our clinical studies build a body of evidence required to drive change, by proving the long-term safety, effectiveness and cost-savings of our technological innovations.

The EnligHTN renal denervation system is no exception. Our clinical investigations show that this system yields successful results for patients with uncontrolled hypertension, with life-changing implications. We have engineered a safe and effective treatment for drug-resistant hypertension backed by extensive clinical support. Three main clinical studies, EnligHTN I, II and III, provide important clinical findings demonstrating the effectiveness of the system. Our clinical evidence page offers more information about these studies.

See Clinical Evidence


The Health and Economic Burden

The International Society of Hypertension estimates 54 percent of stroke, 47 percent of ischemic heart disease, 75 percent of hypertensive disease and 25 percent of other cardiovascular disease worldwide is attributable to hypertension.9 It affects more than 1 billion people worldwide,9 and is a major risk factor for cardiovascular morbidity and mortality.16

The danger grows substantially as a person’s blood pressure rises. In fact, the risk of cardiovascular death from ischemic heart disease, stroke and other vascular diseases doubles for every 20 mmHg systolic or 10 mmHg diastolic increase in blood pressure.6,17-19

Hypertension results in a substantial economic burden worldwide, with $500 billion in hypertension-related costs resulting from heart attack or stroke.20 Treating resistant hypertension will help lower hypertension-related costs.

Hypertension affects more than 1 billion people worldwide(9)
Drawing of heart diagram with parts of the heart labeled with letters

Leading in the Advancement  of Hypertension and Heart Failure Management

At St. Jude Medical, our vision is to transform the treatment of expensive epidemic diseases. To carry that out, we are dedicated to providing you with the broadest scope of innovative, cost-effective and outcome-driven solutions to manage heart failure and hypertension. 

Learn more about our approach to heart failure and hypertension management.

REFERENCES


1. Worthley, S. (2014, May). Longer-term safety and efficacy of catheter-based renal sympathetic denervation using a multi-electrode renal artery denervation catheter in patients with drug-resistant essential hypertension: 24-month results of a first-in-human, multicentre study. Presented at the meeting of the European Association of Percutaneous Cadiovascular Interventions, Paris, France.
2. St. Jude Medical. Data on file, Report Numbers 90090078, 90089179, 90086097, 90110148, 90108950, 90121059, 90118513 and 90125666.
3. Medtronic Symplicity Instructions for Use #LBL039RevB.
4. United States Census Bureau, International Data Base. Retrieved from http://www.census.gov/population/international/data
5. Pereira, M., Lunet, N., Alzeveda,  A., & Barros, H. (2009). Differences in prevalence, awareness, treatment and control of hypertension between developing and developed countries. Journal of Hypertension,27(5), 963-975. http://dx.doi.org/10.1097/HJH.0b013e3283282f65
6. Kearney, P. M., Whelton, M., Reynolds, K., Muntner, P., Whelton, P. K., & He, J. (2005). Global burden of hypertension: Analysis of worldwide data. The Lancet365(9455), 217-223.http://www.thelancet.com/journals/lancet/article/PIIS0140673605177411/abstract
7. Vasan, R. S., Beiser, A., Seshadri, S., Larson, M. G., Kannel, W. B., D’Agostino, R. B., & Leny, D. (2002). Residual lifetime risk for developing hypertension in middle-aged women and men: The Framingham Heart Study. Journal of the American Medical Association287(8), 1003-1010. http://dx.doi.org/10.1001/jama.287.8.1003
8. World Health Organization. (2009). Global Health Risks: Mortality and Burden of Disease Attributable to Selected Major Risks. Geneva, Switzerland: World Health Organization. Retrieved fromhttp://www.who.int/healthinfo/global_burden_disease/GlobalHealthRisks_report_full.pdf
9. Persell, S. D. (2011). Prevalence of resistant hypertension in the United States, 2003-2008. Hypertension57(6), 1076–1080. http://dx.doi.org/10.1161/HYPERTENSIONAHA.111.170308
10. Daugherty, S. L., Powers, J. D., Magid, D. J., Tavel, H. M., Masoudi, F. A., Margolis, K. L., … Ho, P. M. (2012). Incidence and prognosis of resistant hypertension in hypertensive patients. Circulation125(13), 1635-1642. http://dx.doi.org/10.1161/CIRCULATIONAHA.111.068064
11. Joyner, M. J., Charkoudian, N., & Wallin, B. G. (2010). Sympathetic nervous system and blood pressure in humans: Individualized patterns of regulation and their implications. Hypertension56(1), 10-16.http://dx.doi.org/10.1161/HYPERTENSIONAHA.109.140186
12. Grassi, G. (2009). Assessment of sympathetic cardiovascular drive in human hypertension: Achievements and perspectives. Hypertension54(4), 690-697.http://dx.doi.org/10.1161/HYPERTENSIONAHA.108.119883
13. Doumas, M., Faselis, C., & Papademetriou, V. (2010). Renal sympathetic denervation and systemic hypertension. American Journal of Cardiology105(4), 570–576.http://dx.doi.org/10.1016/j.amjcard.2009.10.027
14. Esler, M. (2000). The sympathetic system and hypertension. American Journal of Hypertension13(6 Pt 2), 995-105S. http://dx.doi.org/10.1016/S0895-7061(00)00225-9
15. Worthley, S. (2014, September). Safety and performance of the next-generation EnligHTN™ renal denervation system in patients with drug-resistant hypertension: 12-month results of a first-in-human multicentre study. Presented at the meeting og Transcatheter Cardiovascular Therapeutics, Washington, D.C.
16. DiBona, G. F., & Kopp, U. C. (1997). Neural control of renal function. Physiological Reviews77(1), 75-197. http://www.ncbi.nlm.nih.gov/pubmed/9016301
17. The graph on this page includes data from sources 6 and 7 and was adapted from www.hypertensiononline.org.
18. Lawes, C. M., Vander Hoorn, S., Rodgers, A., & International Society of Hypertension. (2008). Global burden of blood-pressure-related disease, 2001. The Lancet371(9623), 1513-1518.http://dx.doi.org/10.1016/S0140-6736(08)60655-8
19. Lewington, S., Clarke, R., Qizilbash, N., Peto, R., Collins, R., & Prospective Studies Collaboration. (2002). Age-specific relevance of usual blood pressure to vascular mortality: A meta-analysis of individual data for one million adults in 61 prospective studies. The Lancet360(9349), 1903-1913. http://www.ncbi.nlm.nih.gov/pubmed/12493255
20. Heidenreich, P., Trogdon, J., Khavjou, O., Butler, J., Dracup, K., Ezekowitz, M. D., … Woo, J. (2011). Forecasting the future of cardiovascular disease in the United States: A policy statement from the American Heart Association. Circulation123, 933-944. http://dx.doi.org/10.1161/CIR.0b013e31820a55f5

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