Ablative Solutions
Medical Equipment - Wakefield, MA, US
Ablative Solutions Employees
Deborah Schmalz
Global Vice President of Regulatory Affairs and Clinical Research
Katy Vanommeslaeghe
Senior Field Clinical Specialist/Engineer FCS/FCE ; CRA unblinded
Ablative Solutions Details
Ablative Solutions is a clinical-stage medical device start-up that is pioneering the novel approach of Transcatheter Perivascular Alcohol Denervation for the treatment of hypertension. Hypertension, or high blood pressure, is a modern day epidemic, affecting more than one billion people worldwide and an estimated 67 million in the United States alone. Often described as "the silent killer", hypertension is strongly associated with heart disease and stroke. Increased sympathetic nerve activity plays a key role in the pathophysiology of hypertension. By disrupting, or "denervating" these sympathetic nerves, clinicians can alter this overactive signaling process and reduce patients' blood pressure. First-generation approaches using radio-frequency energy produced encouraging results, but these systems are challenged by their inability to reach the target nerves, which lie outside of the treatment range of the energy employed. Ablative Solutions has developed the Peregrine System to perform chemical renal denervation, using alcohol as the neurolytic agent, which may have substantial advantages over energy-based systems. The Peregrine System Infusion Catheter features three equally spaced micro-needles that enable the controlled infusion of a neurolytic agent directly into the perivascular space around the renal arteries, where the sympathetic nerves reside. The Peregrine System has received FDA 510(k) clearance for the infusion of diagnostic and therapeutic agent into the perivascular area of the peripheral vasculature. The device has also received the CE Certificate of Conformity in Europe for the treatment of hypertensive patients. Ablative Solutions is currently conducting a post-market clinical study in Europe to secure additional clinical data. The company is also in the planning stage of a randomized clinical trial in the United States to seek approval for the system's use in the treatment of hypertension.
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