Probably not the most unlikely news item of the week is St. Jude Medical, Inc.’s announcement that interim data demonstrated its EnligHTN™ renal denervation system is safe and effective for the treatment of resistant hypertension.
Data released during a busy European Society of Cardiology (ESC) Congress 2012 demonstrated that on average patients in the EnligHTN I (ARSENAL) trial with resistant hypertension experienced a rapid systolic blood pressure reduction of 28 mmHg points after 30 days that remained stable with a reduction of 27 mmHg points three months after treatment.
It’s probably fair to say by now that renal denervation (RDN) has been clinically proven to reduce blood pressure in patients with hypertension that is resistant to medical therapy. After all, the technique has been around for a few years and several companies, not least St.Jude are claiming success in reducing blood pressure and sustaining that reduction over time.
Unlike the balloon-based devices which typify RDN gizmos, St.Jude’s EnligHTN system is a multi-electrode RF ablation technology. With its unique basket design, each placement of the ablation catheter administers a reliable and repeatable treatment pattern. St.Jude believes that compared to single-electrode ablations systems, the multi-electrode EnligHTN system has the potential to improve consistency, save time and result in workflow and cost efficiencies, although other players make similar claims, notably ReCor with its Paradise, ultrasound based system.
St.Jude also says its basket of electrode design demands minimal catheter repositioning, which it says may result in a reduction of contrast and fluoroscopic (x-ray) exposure.
Inclusion criteria for patients who enrolled in the EnligHTN I trial included an average baseline blood pressure of 176/96 mmHg with blood pressure which had remained resistant despite being on three antihypertensive medications, including a diuretic.
Patients who underwent renal denervation using the EnligHTN technology demonstrated a rapid 22- mmHg point drop in systolic blood pressure just prior to their discharge from the hospital. A further 6-point drop in systolic blood pressure was demonstrated at the 30 day milestone and was sustained at three months.
St.Jude says the total 28mmHg point reduction of systolic blood pressure after 30 days is double the reduction than that of competitive technology in the same time frame (we’ve seen the same figure quoted by Medtronic for its Symplicity device at six months).
This rapid reduction is said by St.Jude to provides earlier improvements in patients who have been resistant to other treatments. Furthermore, three month results demonstrated the technology remained safe and effective with a blood pressure reduction that remained superior to that of competitive technology.
Ambulatory blood pressure measurements presented during the hot line session at ESC further confirmed that the early drop delivered by the EnligHTN system was reliably sustained through the three month time period. Ambulatory rates are important because they are taken outside a clinical setting, where patient blood pressure is not impacted by external factors such as nervousness, and provide a reading that is more consistent and better reflective of real life.
“The risk of cardiovascular death is cut in half with every 20 mmHg decrease in systolic blood pressure, so it is a tremendous benefit to patients that the EnligHTN renal denervation technology is able to reduce blood pressure very rapidly at one month and sustain that reduction,” said the trial’s Primary Investigator Dr. Costas Tsioufis, Prof. of Cardiology at University of Athens Hippocration Hospital and Prof. of Medicine, Georgetown University, Washington DC. “The fact that this rapid and sustained reduction was further confirmed with rigorous ambulatory blood pressure measurements gives me confidence to say that the EnligHTN system delivers a promising therapy for the treatment of resistant hypertension.”
According to Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division, “Hypertension can cause life-threatening health problems and affects more than one billion people around the world. St. Jude Medical is pleased to offer the EnligHTN renal denervation system, which provides to our customers a safe, rapid and sustained treatment for patients at risk with the potential to make immediate and positive changes.”
Source: St.Jude Medical Inc., Business Wire