Medtronic Completes First-In-Man Study for Investigational Next-Generation Multi-Electrode Renal Denervation System in Patients with Treatment-Resistant Hypertension
MINNEAPOLIS - October 3, 2012 - Medtronic, Inc. (NYSE: MDT) announced today that it has successfully completed the first phase of the feasibility study of its next-generation renal denervation system featuring a simultaneously firing multi-electrode catheter and advanced radio-frequency (RF) generator. A total of nine patients were treated with a 100 percent acute success rate in accessing the vessels and delivering therapy. The investigational next-generation Symplicity(TM) system is not commercially available anywhere in the world.
Medtronic's single-electrode Symplicity renal denervation systemhas been used for five years to treat more than 5,000 patients with treatment-resistant hypertension worldwide. The single-electrode Symplicity system's catheter and proprietary generator and algorithms were carefully and specifically developed through years of clinical experience to enhance the safety and effectiveness of the renal denervation procedure. The single-electrode Symplicity(TM) renal denervation system is only available in the United States for investigational use.
The next-generation renal denervation system builds upon Medtronic's experience with the Symplicity(TM) system for treatment-resistant hypertension, demonstrating the company's commitment to the development and advancement of renal denervation technology based on critical physician and patient needs. The next-generation system will feature a new four electrode catheter that delivers RF energy simultaneously and is designed to significantly reduce ablation time during renal denervation procedures. The new catheter will be 6 Fr compatible, highly conformable with a non-occluding design. This new design is intended to provide ease of deliverability and consistency of RF energy application, while also enabling the treatment of a wide range of renal anatomies.
The next-generation Medtronic renal denervation system also incorporates a new generator with an improved user interface. The new generator will leverage the benefits of Medtronic's proven and proprietary Symplicity(TM) treatment algorithm with its built-in safety features and will be compatible with both the single-electrode Symplicity(TM) catheter and the next-eneration multi-electrode catheter.
"Renal denervation is an important advancement in the management of treatment-resistant hypertension," said Robert Whitbourn, M.D., Professor/Director of the Cardiac Cath Labs & Coronary Intervention, St Vincent's Hospital, Melbourne, Australia and principal investigator of the study. "This next-generation system has several innovative features that could take this procedure to the next level by providing the flexibility to treat a wide range of different anatomies, as well as helping to improve efficiency of care through significantly reduced ablation and procedure times."
Renal denervation therapy is a minimally invasive, catheter-based procedure that modulates the output of nerves that line the walls of the arteries leading to the kidneys. These nerves impact the sympathetic nervous system, which affects the major organs that are responsible for regulating blood pressure: the brain, the heart, the kidneys and the blood vessels.
"We look forward to moving forward with our clinical evaluation of this next-generation system that aims to augment our portfolio by offering more sophisticated features that should benefit both physicians and patients," said Sean Salmon, Senior Vice President and President, Coronary & Renal Denervation, Medtronic. "This feasibility study represents Medtronic's commitment to providing physicians with a broader range of solutions for performing renal denervation and to collaborating with physician partners in the ongoing evaluation of this groundbreaking therapy."
ABOUT TREATMENT-RESISTANT HYPERTENSION
Treatment-resistant hypertension, defined as persistently high blood pressure despite three or more anti-hypertensive medications of different types including a diuretic, puts approximately 120 million people worldwide at risk of premature death from kidney disease and cardiovascular events such as stroke, heart attack and heart failure. Research suggests that nearly one third of treated hypertensive individuals are considered resistant to treatment.[i] Additionally, these patients have a three-fold increase in risk of cardiovascular events compared to individuals with controlled high blood pressure.[ii]
About the SINGLE-ELECTRODE Symplicity(TM)Renal Denervation System
The Symplicity renal denervation system consists of a flexible catheter and proprietary generator. In an endovascular procedure, similar to an angioplasty, the physician inserts the small, flexible Symplicity(TM) catheter into the femoral artery in the upper thigh and threads it into the renal artery. Once the catheter tip is in place within the renal artery, the Symplicity(TM) generator is activated to deliver a controlled, low-power RF energy routine according to a proprietary algorithm, or pattern, aiming to deactivate the surrounding renal nerves. This, in turn, reduces hyper-activation of the sympathetic nervous system, which is an established contributor to chronic hypertension. The procedure does not involve a permanent implant.
The FDA granted Medtronic approval for the protocol for SYMPLICITY HTN-3, the company's U.S. clinical trial of the single-electrode Symplicity renal denervation system for treatment-resistant hypertension, in August 2011. More information about SYMPLICITY HTN-3 can be found at www.symplifybptrial.com.
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