St. Jude Medical, Inc., has gained CE Mark approval of its next-generation EnligHTN™ Renal Denervation System for treating patients with drug-resistant, uncontrolled hypertension. The company promises a time reduction from 24 minutes using its first device, to just 4 minutes.
St.Jude Medical’s EnligHTN device is probably well known to our readers by now, being a basket of electrodes that each come into contact with the wall of the renal artery and deliver radiofrequency energy at a level designed to zap the functionality of the sympathic nerves lying alongside the vessels.
The new system looks the same, but compared with the original, features an advanced generator that delivers simultaneous ablations, reducing total ablation time by more than 80 percent in comparison to the first generation system. 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 is currently being evaluated in the EnligHTN III study, an international, non-randomized clinical trial that will enroll up to 50 patients in Australia and New Zealand. This study expands on EnligHTN I trial research of the first generation EnligHTN system, which demonstrated that patients with drug-resistant hypertension had a safe, rapid and sustained drop in blood pressure. After thirty days, systolic blood pressure was reduced by an average of 28 mmHg (millimeters of mercury) that remained stable with a reduction of 27 mmHg points one year after treatment.
St.Jude says the EnligHTN system will be on display during the forthcoming 2013 European Society of Cardiology (ESC) meeting from August 31 to September 3.
“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 University Hospital in Zurich and editor in chief of the European Heart Journal. “Renal denervation is a relatively simple, minimally-invasive procedure that is emerging as an important new avenue for managing hypertensive patients who do not respond to medications.”
“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 Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “These advancements deliver on our strategy to bring new innovations to a developing market to provide options for patients who currently do not have an adequate treatment for their uncontrolled drug-resistant hypertension.”
Source: St.Jude Medical, Inc., Business Wire