St. Jude Medical (NYSE:STJ) won CE Mark approval in the European Union for its next-generation EnligHTN renal denervation system, which the company says can cut ablation time by as much as 80%.
The device, indicted for use in patients with drug-resistant, uncontrolled hypertension, is slated for launch during the 2013 European Society of Cardiology meeting from August 31 to September 3 where EnligHTN will be on display, the St. Paul, Minn.-based medical device said in a press release.
The EnligHTN device applies radiofrequency energy to create tiny scars along nerves that control blood pressure. A multi-electrode catheter and newer energy-generator deliver simultaneous ablations, reducing total ablation time from around 24 minutes to 4 minutes, St. Jude said.
The 1st-generation EnligHTN Renal Denervation System gained a European CE Mark in 2012 and was launched in several markets, but the EnligHTN systems are not yet approved for use in the U.S.
"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," cardiovascular and ablation technologies president Frank Callaghan said in prepared remarks. "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."
The World Health Organization estimates that there are more than 100 million people worldwide with treatment resistant hypertension, for whom at least 3 high blood pressure drugs have failed. Global health care costs directly related to hypertension are estimated at almost $508.51 billion (€385 billion) each year.
The use of catheter-based renal denervation for patients with drug-resistant hypertension was recently recommended in guidelines issued by the European Society of Cardiology and the European Assn. of Percutaneous Cardiovascular Interventions, St. Jude noted.
More EnligHTN trials in the works
St. Jude earlier this year kicked off a U.S. trial for EnligHTN and the company is conducting a total of 5 renal denervation studies including the EnligHTNment trial, the 1st large-scale trial evaluating the long-term effects of renal denervation, the company said.
The EnligHTNment study will evaluate whether the therapy reduces the risk of heart attack, stroke, heart failure requiring hospitalization, and cardiovascular death in patients with uncontrolled hypertension.
The next-generation EnligHTN system is under evaluation in the EnligHTN III study, an international, non-randomized clinical trial that will enroll up to 50 patients in Australia and New Zealand. EnligHTN III aims to expand on data from the 1st-generation EnligHTN trial, which showed that patients with drug-resistant hypertension had a safe, rapid and sustained drop in blood pressure, according to St. Jude Medical.
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