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Hypertension affects an estimated 1 billion people worldwide, and an estimated 65 million adults in the United States(1,2). It is a major risk factor for heart disease, stroke, congestive heart failure, metabolic syndrome, obstructive sleep apnea and kidney disease.  One out of every six adult deaths is attributable to hypertension, and the economic burden in the US exceeds $76.6 Billion. The World Health Organization (WHO) estimates that worldwide, more than 17 million deaths each year are attributable to cardiovascular disease, with hypertension being a substantial contributor to these deaths(3).

A significant subset of the treated patients are medication-resistant or “refractory” and do not achieve target blood pressure levels, despite taking daily doses of three or more medications(4,5,6). In the US, approximately 6 million individuals suffer from refractory hypertension(4).

Early studies of renal denervation demonstrated a reduction in blood pressure in patients who are not effectively treated by medical therapy.  While a recent trial did not show such definitive results in blood pressure reduction, there is still much to be learned about the potential benefits of modulating overactive sympathetic nerve signalling.   The sympathetic nerves that run along the renal artery play an essential role in controlling blood pressure but, when overactive, contribute to hypertension.  Deactivating these nerves altersthe signaling process, and may help to reduce blood pressure and may yield other clinical benefits. Unlike other approaches to renal denervation that depend upon transmural delivery of destructive energy, Ablative Solutions is investigating a treatment that delivers therapy directly to the nerves that encircle the renal artery, with the intent of delivering more complete denervation without damage to the arteries – PeriVascular Renal Denervation (PVRD™).     The company’s Peregrine System™ Infusion Catheter is cleared for delivery of diagnostic and therapeutic agents directly to the perivascular layer that surrounds blood vessels.    A clinical evaluation of PeriVascular Renal Denervation using the Peregrine System is scheduled to begin in Europe in 2014.

Ablative Solutions, Inc., was founded in 2011 by Tim Fischell, MD, FACC, and David Fischell, PhD, to address this significant unmet medical need.  Ablative Solutions’ technology involves endovascular catheters to provide an efficacious, durable, cost-effective and safe alternative to surgical renal denervation for the treatment of hypertension and other diseases caused by an overactive sympathetic nervous system.

 

 

1Hajjar, I., J. M. Kotchen, and T. A. Kotchen. 2006. Hypertension: Trends in Prevalence, Incidence, and Control. Annu. Rev. Public Health. 27:465-490.

2Egan, B. M., Y. Zhao, and R. N. Axon. 2010. US Trends in Prevalence, Awareness, Treatment and Control of Hypertension, 1988-2008. JAMA. 303(20):2043-2050.

3Dib, M. W., R. Riera, and M. B. Ferraz. 2010. Estimated annual cost of arterial hypertension treatment in Brazil. Rev Panam Salud Publica. 27(2):125-131.

4Perselli, S. D. 2011. Prevalence of Resistant Hypertension in the United States, 2003-2008. Hypertension. 57:1076-1080.

5Krum, H., M. Schlaich, R. Whitbourn, P. A. Sobotka, J. Sadowski, K. Bartus, B. Kapelak, A. Walton, H.Sievert, S. Thambar, W. T. Abraham, and M. Esler. 2009. Catheter-based renal sympathietic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet.373:1275-1281.

6Oparil, S. 2011. Can Catheter-Based Renal Denervation Be Used Safely and Effectively to Substantially Reduce Blood Pressure in Treatment-Resistant Hypersensitive Patients. Curr Cardiol Rep.13(6):478-480.