|By PR Newswire||
|April 14, 2014 06:00 AM EDT||
SAN CLEMENTE, Calif., April 14, 2014 /PRNewswire/ -- ROX Medical today announced it has completed enrollment for CONTROL-HTN trial, an international multi center, prospective, randomized, controlled, blinded endpoint trial of the ROX Coupler for the treatment of arterial hypertension. The CONTROL-HTN trial, NCT01642498, is evaluating the safety and efficacy of a percutaneous procedure creating a fixed connection between a central artery and vein in the upper leg - for the treatment of hypertension. The primary outcomes are the safety and efficacy of the ROX Coupler in reduction of ambulatory and office blood pressure at 6 months post procedure. Paul A. Sobotka, MD, Chief Scientific Officer of ROX Medical, anticipates that last data obtained and results to be presented in the fall of 2014.
ROX Medical's FLOW procedure is a minimally invasive, under one-hour, straight forward, catheter based procedure performed by interventional cardiologists, radiologists and vascular surgeons. It places the ROX Coupler between a central artery and vein in the upper leg creating a fixed volume arterial-venous anastomosis, which immediately reduces blood pressure, and vascular resistance while increasing arterial compliance.
"We are very pleased with the continued strong interest in the ROX procedure to increase the choices available to patients and physicians for the treatment of hypertension," commented ROX CEO Rodney Brenneman, "the immediately evident effects of the ROX treatment are gratifying to both the patient and interventional physician, and we are optimistic that this trial will demonstrate a durable and safe means of reducing blood pressure. The benefits of device mediated blood pressure therapy are obvious for patients unable or unwilling to sustain life long poly-pharmacy, and provide an absolutely unique and novel treatment strategy for severe hypertension."
The ROX FLOW procedure for hypertension is not approved for use in the U.S.
SOURCE ROX Medical
Jan. 18, 2017 02:30 AM EST Reads: 1,810
Jan. 18, 2017 02:15 AM EST Reads: 3,203
Jan. 18, 2017 01:30 AM EST Reads: 4,199
Jan. 18, 2017 01:15 AM EST Reads: 4,869
Jan. 18, 2017 01:00 AM EST Reads: 2,011
Jan. 18, 2017 01:00 AM EST Reads: 6,045
Jan. 18, 2017 12:45 AM EST Reads: 6,250
Jan. 18, 2017 12:45 AM EST Reads: 5,949
Jan. 18, 2017 12:30 AM EST Reads: 2,784
Jan. 18, 2017 12:00 AM EST Reads: 2,258
Jan. 18, 2017 12:00 AM EST Reads: 7,737
Jan. 17, 2017 11:30 PM EST Reads: 4,350
Jan. 17, 2017 11:15 PM EST Reads: 4,936
Jan. 17, 2017 11:00 PM EST Reads: 595
IoT is at the core or many Digital Transformation initiatives with the goal of re-inventing a company's business model. We all agree that collecting relevant IoT data will result in massive amounts of data needing to be stored. However, with the rapid development of IoT devices and ongoing business model transformation, we are not able to predict the volume and growth of IoT data. And with the lack of IoT history, traditional methods of IT and infrastructure planning based on the past do not app...
Jan. 17, 2017 10:30 PM EST Reads: 734