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St. Jude Medical receives European approval for new renal denervation system that greatly reduces total ablation time
The next-generation EnligHTN Renal Denervation System delivers simultaneous ablations via a multi-electrode catheter, reducing ablation times from approximately 24 minutes to four minutes. Image courtesy of
“The new EnligHTN system improves the procedure by significantly reducing ablation time and providing optimized ablation monitoring feedback,” said Thomas Lüscher, professor and chairman of Cardiology, at the Cardiovascular Center at the
Renal denervation is a catheter-based ablation procedure used to treat patients with drug-resistant hypertension (high blood pressure). The EnligHTN system delivers radiofrequency (RF) energy from an ablation catheter to create lesions (tiny scars) along the renal nerves – a network of nerves in the walls of the renal arteries thought to help control blood pressure. The intentional disruption of the nerve supply has been clinically found to help reduce systolic and diastolic blood pressure. The system catheter has a unique, non-occlusive basket design, helping physicians deliver a predictable treatment pattern while allowing for continuous blood flow to the kidney throughout the procedure.
Blood pressure reduction is quickly achieved by simultaneously administering 60 second ablations from all four catheter electrodes, which is typically performed two times in each renal artery. The advanced generator also has an icon-based touch screen interface that allows physicians to easily view and record procedure information.
“The next generation EnligHTN system offers physicians our proven multi-electrode catheter with a new intuitive, faster generator that quickly and effectively delivers consistent ablations with a significant reduction in procedure time,” said
Renal denervation represents an important area of research.
The next-generation EnligHTN system is currently being evaluated in the EnligHTN III study, an international, non-randomized clinical trial that will enroll up to 50 patients in
A normal blood pressure is typically at or below 120 systolic and 80 diastolic, expressed as 120/80 mmHg. Hypertension is categorized as a blood pressure reading greater than 140/90 mmHg. Lowering hypertension is important as the risk of cardiovascular death doubles with every 20 point increase in systolic blood pressure.
Hypertension or “high blood pressure” is a common medical condition that can cause life-threatening health problems such as heart disease, stroke or kidney failure that affects one in three adults worldwide according to the World Health Organization (WHO). Known as the “silent killer,” high blood pressure often presents no warning signs or symptoms and many people do not realize they have it. Drug-resistant hypertension is a condition that cannot be controlled through medication. There are more than 100 million people worldwide that are treatment resistant where at least three high blood pressure drugs do not work. The annual global health care expenditure directly related to hypertension is estimated at almost
To learn more about renal denervation or see a demo of the next-generation EnligHTN Renal Denervation System, ESC attendees can visit
In 2012, the first-generation EnligHTN Renal Denervation System earned European CE Mark approval and was launched in several markets. The EnligHTN systems are not approved for use in the U.S.