With late breaking trials, spirited debates, and hundreds of other great talks, the American College of Cardiology's 2012 (ACC.12) annual meeting in Chicago this past weekend provided a ton of exciting news. Standing out from the crowd was a panel of talks on renal denervation, a promising catheter-based treatment for hypertension, and clearly the topic of the week.
Hypertension represents one of the most common diseases around the world and is thought to be increasing in prevalence due to western habits and lifestyle. There are a myriad of complications associated with hypertension, including chronic kidney disease, stroke, and coronary artery disease, among others. Traditionally treated with medication, there remains a significant portion of patients whose blood pressure cannot be controlled by drugs, placing them at a high risk for developing these complications. This large patient population that can't be treated pharmaceutically offers a potential gold mine for manufacturers.
During a renal denervation procedure, a radiofrequency ablation catheter is fed through the groin into the renal arteries and creates a series of lesions, ablating the renal sympathetic nerve. Results presented at the ACC.12 meeting demonstrated that renal denervation continues to be successful 3 years post procedure, resulting in a marked decrease in blood pressure that appears sustained and stable. Furthermore, results presented during the panel suggested that 100% of patients responded to the treatment after 3 years. These results are very exciting previous updates at the 1- and 2-year marks post procedure showed only 64% and 82%, respectively, of patients responded.
Medtronic's acquisition of Ardian has given it the lead in the renal denervation field, with its product having already attained CE approval in Europe and the largest set of clinical data thus far. However, there remains some uncertainty surrounding the procedure. For example, some skeptics have raised questions about the company's SYMPLICITY HTN-1 and HTN-2 trials because ambulatory blood pressure monitoring was not extensively used and there was no sham procedure that could have generated a placebo response.
Medtronic is, however, addressing these concerns in the SYMPLICITY HTN-3 pivotal trial in the US, which is currently enrolling patients. Results from the HTN-3 trial, and real world usage from European centers, will help to answer the lingering questions about renal denervation. And saying that there is great potential for this treatment is almost understating its potential impact positive results could push renal denervation to become one of the biggest medical device successes to date. Everyone will definitely be keeping an eye on this technology through 2012.