Ablative Solutions initiated a study in Poland to test an infusion catheter it believes can treat hypertension by interrupting signals from sympathetic nerves located in the outer layer of the renal artery.
The sympathetic nervous system governs the body’s "fight or flight" response to stimuli, with the counterbalancing parasympathetic nervous system which regulates "rest and digest" functions in the body. Kalamazoo, Mich.-based Ablative Solutions says interruption of sympathetic nerve pathways could help treat not just hypertension but also metabolic syndromes, congestive heart failure and obesity.
The study is enrolling patients at 1 hospitals in The American Heart of Poland Group, which bills itself as the biggest cardiology network in the Polish market, and will be expanded to include other European clinical sites as Ablative Solutions seeks CE Mark approval for the product as a treatment for hypertension.
"We believe that a safe, reproducible, easy-to-use and more targeted denervation technology with limited pain to the patients will be more effective than energy-based catheter approaches in mitigating overactive sympathetic nerves," CEO Dr. Tim Fischell said in prepared remarks.
"Early experience with surgical sympathectomy has demonstrated that effective interruption of these nerves had a beneficial effect on blood pressure. We hope that chemical neurolysis will provide a minimally invasive approach that builds upon some of the early successes of renal denervation, while avoiding many of pitfalls encountered by energy-based systems," Fischell added.
Last February, Ablative Solutions raised $9.5 million in funding from BioStar Ventures, the Michigan Accelerator Fund and other investors. In June, the company won U.S. patent protection for its infusion catheter, with some aspects of the patent covering unique micro-needle-equipped catheters for the precise delivery of fluids into a variety of tissue targets.