The 1st patient enrolled today in a St. Jude Medical (NYSE:STJ)-sponsored trial to evaluate the safety and performance of a new renal denervation system in patients with drug-resistant, uncontrolled hypertension, the company said.
The EnligHTN systems deliver radiofrequency energy from an ablation catheter to create lesions along the renal nerves – a network of nerves thought to help control blood pressure. The intentional disruption of the nerve supply has been clinically found to cause systolic and diastolic blood pressure to decrease, the St. Paul, Minn.-based medical device company said in a press statement.
The next-generation EnligHTN system being evaluated in the new trial reduces total ablation time from around 24 minutes to 4 minutes by pairing a multi-electrode catheter with a new generator, the company said. The novel generator features a high-tech, icon-friendly, touch screen user interface that provides simultaneous ablations using four electrodes and allows physicians to easily view and record procedure information.
"Lowering hypertension is important as the risk of cardiovascular death doubles with every 20 point increase in systolic blood pressure," EnligHTN III principal investigator Dr. Stephen Worthley of St. Andrew’s Hospital in Adelaide, Australia, said in a press statement. "The ability of the next-generation EnligHTN system to deliver simultaneous ablations and the intuitive touch screen on the generator are advancements that simplified use, markedly reduced procedure times and was well tolerated by our patients."
According to the World Health Organization, 1 in 3 adults worldwide has elevated blood pressure – a condition that increases the risk of heart attack, stroke and kidney failure.
And the European Society of Cardiology and the European Assn. of Percutaneous Cardiovascular Interventions recently issued guidelines recommending the use of catheter-based renal denervation for the treatment of high blood pressure in patients with difficult-to-treat, drug-resistant hypertension.
Due to its unique non-occlusive basket design, the EnligHTN system administers a predictable treatment pattern with each placement of the ablation catheter while allowing for continuous blood flow to the kidney throughout the procedure, St. Jude Medical claimed.
The EnligHTN III study is an international, non-randomized clinical trial that will enroll up to 50 patients in Australia and New Zealand whose hypertension cannot be controlled with drugs. To qualify for the study, participants must have systolic blood pressure that remains greater than 160 mmHg as measured during office visits, despite the use of 3 antihypertensive medications concurrently at the maximum tolerated doses, one of which is a diuretic.
This study expands upon the research conducted in the EnligHTN I trial of the 1st generation EnligHTN system, which demonstrated that patients with drug-resistant hypertension had a safe, rapid and sustained drop in blood pressure. After 30 days, systolic blood pressure was reduced by an average of 28 mmHg that remained stable with a reduction of 26 mmHg points six months after treatment.
While not yet approved in the U.S., the first-generation EnligHTN renal denervation system earned European CE Mark approval in 2012, and was launched in several markets. The 2nd-generation EnligHTN system is not approved anywhere in the world.
"St. Jude Medical has a long history of advancements in ablation technologies, which allowed us to quickly bring the first-generation EnligHTN system to the European market in early 2012," cardiovascular & ablation technologies president Frank Callaghan said in prepared remarks. "Now, less than 1 year later, we are pleased to bring this innovative therapy to EnligHTN III, a new clinical study evaluating technology advancements in our next-generation system."