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Vessix Vascular, Inc. to Present 3-Month, 6-Month Results From REDUCE-HTN Renal Denervation Clinical Study at TCT


10/22/2012 10:30:11 AM

LAGUNA HILLS, Calif., Oct. 22, 2012 /PRNewswire/ -- Vessix Vascular, Inc., a developer of novel percutaneous radiofrequency (RF) balloon catheter technology for the treatment of hypertension, announced today that it would present the latest REDUCE-HTN renal denervation clinical study data at this year's Transcatheter Cardiovascular Therapeutics (TCT) meeting to be held Oct. 22-26 at the Miami Beach Convention Center in Miami.

On October 25, Dr. Eric Wyffels of the Cardiovascular Center in Aalst, Belgium will transmit a live Vessix renal denervation procedure in the Main Arena at TCT.

Renal denervation is a percutaneous, catheter-based therapy that disrupts renal sympathetic nerves whose hyperactivity leads to uncontrolled high blood pressure.

REDUCE-HTN is a 120-patient post-market approval clinical surveillance study of medication resistant hypertensive patients employing the Vessix V2 Renal Denervation System that is being conducted at more than 20 leading international centers located in Germany, Austria, Switzerland, Belgium, the Netherlands, France, Australia, and New Zealand. REDUCE-HTN is evaluating the ability of the Vessix System to reduce the systolic and diastolic blood pressure at six months as compared to the pre-treatment baseline blood pressures of patients.

"REDUCE-HTN is one of the largest renal denervation studies actively enrolling patients," said Vessix CEO, Raymond W. Cohen, "We are working with many of the world's experts in renal denervation and our clinical data suggests that the Vessix System is safe and efficacious and provides clinicians with a treatment that is faster and easier to use than any method or technology currently available."

Hypertension, commonly known as high blood pressure and the leading attributable cause of death worldwide, occurs when the nerves regulating the body's major organs, including the brain, heart, kidneys and blood vessels, become hyperactive. According to the American Heart Association, a 5 mm Hg (millimeters of mercury) reduction in systolic blood pressure results in a 14 percent decrease in stroke, a 9 percent decrease in heart disease, and a 7 percent decrease in overall mortality. Renal denervation has shown in clinical studies to be safe, durable and effective in reducing systolic blood pressure by over 30 mm Hg or approximately 20 percent from baseline.

Find Vessix at TCT 2012

Vessix will be exhibiting its V2 System in booth #120 at the TCT 2012 conference to be held October 22-26 in Miami and will feature the following presentations and live cases:

Tuesday, October 23 Room D231-232

10:45AM "Efficacy of Renal Denervation Is Positively Impacted by Longitudinal Treatments"

Wednesday, October 24 Room A201-202

4:28PM Emerging Technologies for Renal Denervation-Vessix Vascular

Thursday, October 25 Main Arena II Plenary Session Live Cases

8:45AM Live Vessix Procedure from Cardiovascular Center Aalst

Thursday, October 25 Presentation Theater 1

10:30AM Taped Live Case RF balloon Catheter Renal Denervation Treatment of a Patient with Uncontrolled Hypertension

About the Market for Renal Denervation

Industry analysts suggest that there are more than 12 million patients worldwide whose blood pressure remains uncontrolled, despite taking three or more anti-hypertensive medications. This represents a global market opportunity for renal denervation that could ultimately grow to $30 billion.

About the Vessix V2 Renal Denervation System

  • The Vessix System for the treatment of hypertension is an over-the-wire balloon catheter with an array of RF electrodes in a precise pattern designed to deliver a modest dose of RF energy to disrupt the renal nerves located in the adventitia that surround the renal artery. The patented RF balloon catheter connects to a proprietary bipolar RF generator specifically designed and optimized for the renal denervation clinical application.
  • Therapy is delivered via a balloon catheter that is quite familiar to interventional cardiologists and other physicians, thereby increasing the usability and safety profile of the device.
  • The Vessix balloon catheter occludes blood flow to the renal artery during the 30-second RF therapy delivery allowing for a directed and highly controlled flow of energy to the target nerves. Consequently, the V2 is significantly faster by an order of magnitude than renal denervation systems currently marketed.
  • Rapid RF treatment time greatly increases the efficiency of the denervation procedure and promises additional safety benefits to the clinician conducting the procedure, and the patient, based on less use of contrast dye and lower exposure to radiation.

About Vessix Vascular, Inc.

Founded in 2003, Vessix is a privately held company developing novel radiofrequency balloon catheter technology. Vessix is backed by world-class European and U.S. venture capital firms including NeoMed Management, Edmond de Rothschild Investment Partners and OrbiMed Advisors LLC. For more information on Vessix Vascular, please visit the Company's website at www.vessixvascular.com or contact Matt Clawson at Allen & Caron Inc at 949-474-4300 or via email at matt@allencaron.com.

Contact:

Matt Clawson or


Len Hall (Media)


Allen & Caron Inc


949-474-4300
matt@allencaron.com


len@allencaron.com

SOURCE Vessix Vascular, Inc.



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