Medical company’s latest renal denervation procedure cuts procedure time by 80%.
Global medical device company St. Jude Medical Inc., announced that it has received the European CE Mark of approval for its EnligHTN™ Renal Denervation System for treating patients with drug-resistant, uncontrolled hypertension.
Renal denervation is a catheter-based procedure whereby the nerves connecting the kidney to the brain are removed or ablated. It is a relatively simple, minimally-invasive, and safe procedure that is emerging as an important new treatment for patients with drug-resistant high blood pressure.
St. Jude Medical said in a statement that compared to its predecessor, the new EnligHTN™ system features an advanced generator that delivers simultaneous ablations via a multi-electrode catheter, reducing total ablation time by more than 80 percent, from about 24 minutes to four minutes. Basically, it works by delivering radiofrequency (RF) energy from an ablation catheter to create lesions (tiny scars) along the renal nerves.
Frank J. Callaghan, president of St. Jude Medical Cardiovascular and Ablation Technologies Division, commented that “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. 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.”
EnligHTN™ is currently undergoing an international, non-randomized clinical trial involving up to 50 patients in Australia and New Zealand. After 30 days into the trial, systolic blood pressure was reduced by an average of 28 mmHg and remained stable with a reduction of 27 mmHg points one year after treatment.
St. Jude Medical said it is also conducting the first, large-scale trial “that will examine the long-term effects of renal denervation to see if the therapy also reduces the risk of heart attack, stroke, heart failure requiring hospitalization, as well as cardiovascular death in patients with uncontrolled hypertension.”
Renal denervation is an important area of research. The European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) recently issued guidelines recommending the use of the treatment in patients with drug-resistant hypertension.