VALENCIA, Calif., Oct. 26, 2016 /PRNewswire/ -- Valencia Technologies Corporation ("Valencia"), a privately held medical device company, today announced that it will for the first time publicly present its First-in-Human Clinical Trial Results on the use of eCoin in resistant hypertension, as well as showcase eCoin as a novel alternative therapy to renal denervation during the 2016 Transcatheter Cardiovascular Therapeutics (TCT) symposium in Washington D.C. October 29-November 2.
Valencia's global principal investigator, Mark Webster, MD, of University of Auckland, will present "Neuromodulation for the Treatment of Resistant Hypertension: First-in Human Evaluation of an Implanted Median Nerve Stimulator" on Tuesday, November 1, 2016 at 11:45am EST as part of TCT's "Interventional Innovation III: Early Feasibility and First-in-Human Studies" session.
"The eCoin First-in-Human trial showed that intermittent median nerve stimulation via a small easily-implanted device holds considerable promise for the treatment of refractory hypertension," said Dr. Webster. "The randomized, controlled, blinded, crossover study provided useful insights into determining those most likely to respond, to better target treatment and inform design of the US pivotal trial."
In total, 96 eCoin devices were implanted in 48 drug-resistant hypertensive subjects from New Zealand, Taiwan, and Canada during in-office procedures under local anesthetic. With an average implant time from incision to suture of 13.5 minutes per arm, the eCoin devices were inserted just under the skin and atop the median nerve approximately 1/5 the distance from the wrist crease to the elbow crease. Subjects were randomized four weeks after implantation and monitored at 1, 3, 6, 9, 12, 18, and 24 month follow-up visits. Efficacy endpoints studied change in both in-office and 24-hr SBP from baseline to six months post-activation. With the study now complete, Dr. Webster's presentation will include full primary and secondary efficacy and safety endpoints. According to Dr. Webster, "Most patients were very happy with the device and we are now assessing long-term response by undertaking extended follow-up in the New Zealand patient cohort."
As a complementary presentation of the technology, "For the first time at TCT, median nerve stimulation via the eCoin will be discussed in a special session on device therapy for hypertension and contrasted to other new treatment modalities such as intravascular renal denervation, arteriovenous fistulae, and external ultrasonic denervation," according to William B. White, MD, Professor in the Cardiology Center at the University of Connecticut School of Medicine. White will present "Median Nerve Stimulation for Refractory Hypertension: Valencia Technologies" as part of TCT's "Didactic Session: Interventional Therapies for Hypertension (Renal Denervation and Beyond)" at 5:09pm EST on Sunday, October 30, 2016.
"The Valencia eCoin provides a novel approach to reducing blood pressure in patients with drug resistant hypertension," opined White, whose presentation will focus on eCoin's low-duty cycle, its mechanism of action, the simplicity of its implantation, its benign safety profile, a glimpse at the First-in-Human analyses, and information on the upcoming IDE approved Pivotal for which he will serve as one of the national principal investigators.
Both presentations will be in the Walter E. Washington Convention Center, Room 209, Level 2.
Valencia's eCoin System is not approved for sale or commercial distribution, and is limited to investigational use only. For more information about Valencia's upcoming pivotal study for the treatment of resistant hypertension, please visit www.clinicaltrials.gov.
Valencia Technologies Corporation is a medical technology company located in Valencia, California. Valencia's coin-sized and shaped bioelectronic device, eCoin, can be implanted near various target nerves for the treatment of a number of chronic conditions. Feasibility studies in heart failure, overactive bladder, and osteoarthritis of the knee are planned to begin next year.
Transcatheter Cardiovascular Therapeutics (TCT) is the world's largest and most important educational meeting specializing in interventional cardiovascular medicine. For over 25 years, TCT has been the center of cutting-edge educational content, showcasing the latest advances in current therapies and clinical research. For more information, visit http://www.crf.org/tct
For more information on Valencia, please visit the website: www.valenciatechnologies.com.
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Last updated on: 26/10/2016
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