Renal Dynamics has successfully treated the first patient in its TREAT-HTN prospective, post-marketing multi-center European clinical study to evaluate the safety and efficacy of its third-generation Renal Denervation (ReDy™) System.
The ReDy System is based on a novel multi-electrode ablation technology that delivers a pre-determined RF ablation set with a single positioning. The system incorporates a universal renal denervation catheter and SmartRF Generator, combining bipolar and unipolar power with a proprietary algorithm that ensures complete lesion formation without unnecessary energy delivery.
The first procedure was performed by Professor Evgeny Pokushalov’s team, including Dr. Alexander Romanov and Dr. Vitaly Shabanov, at the Academician E.N. Meshalkin State Research Institute of Circulation Pathology, in Novosibirsk, Russia.
“The ReDy System is an important advancement in treatment of uncontrolled hypertensive patients,” commented Professor Pokushalov. “It has the potential to improve the overall effectiveness of renal denervation procedures by employing a novel multi-electrode single 5Fr catheter to treat a wide range of renal artery sizes and anatomies.”
“We are very encouraged and pleased to have the first patient enrolled in this study, which utilizes a proprietary Quality of Lesion algorithm to better enable more effective renal denervation procedures,” said Dr. Felix Mahfoud, Primary Investigator of the TREAT-HTN study, from Saarland University Hospital in Homburg, Germany.
Renal Dynamics received the CE Mark for the ReDy System in November 2015 and has initiated its multi-center post-market clinical study to further support existing data indicating that the ReDy system is safe and effective.
Shawn Moaddeb, President and CEO of Renal Dynamics, said, “The beginning of enrollment in the TREAT-HTN clinical trial is a major milestone for the company as we continue to gain clinical experience with our system, and advances our efforts in bringing a better therapy to treat hypertension with a single intervention.”
Hypertension is a chronic medical condition in which blood pressure in the arteries is elevated. Blood pressure is expressed by two measurements, systolic and diastolic pressures, which are the maximum and minimum pressures, respectively, in the arterial system. Normal blood pressure at rest is within the range of 100-140 mmHg systolic and 60-90 mmHg diastolic. Hypertension is present if the blood pressure is persistently at or above 140/90 mmHg for adults. Sustained hypertension over time is a major risk factor for heart disease, coronary artery disease, stroke, aortic aneurysm, peripheral artery disease and chronic kidney disease. Hypertension affects over 1 billion people worldwide.
About renal denervation
Renal denervation is an interventional approach for the treatment of high blood pressure. A minimally-invasive, endovascular-catheter-based procedure, it uses radiofrequency or ultrasound ablation to treat resistant hypertension. Nerves in the wall of the renal artery are ablated through the application of radiofrequency pulses to the renal arteries. This causes reduction of sympathetic activity in the kidney, resulting in a clinically-relevant decrease in blood pressure.
About Renal Dynamics
Renal Dynamics (ReDy), a member of the Hobart Group of companies, is dedicated to treating hypertension with a single intervention, using its proprietary Renal Denervation System. ReDy is focused on developing a solution that is easy and quick to administer, uses one universal catheter and provides increased patient comfort. For more information, visit Renal-Dynamics.com.
About Hobart Group
The Hobart Group develops and commercializes medical technologies, targeting top healthcare markets with significant unmet needs. Its growing portfolio of companies covers the areas of cardiology, diabetes, oncology, neurology and rehabilitation. Together, Hobart Group companies have over 200 scientists, engineers, regulatory and business experts across four continents, benefitting from clinical expertise and extensive regulatory and international market knowledge across Europe, the USA and Asia. For more information, visit www.Hobart-Group.com.
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