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Hypertension News & Press

ROX Medical study results published in The Lancet

San Clemente, CA | January 22, 2015

A major milestone has been achieved by the ROX Medical RH-02 investigator team. The journal The Lancet has published the article entitled, "Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial." The study results suggest that an arteriovenous anastomosis was associated with significantly reduced blood pressure and hypertensive complications and that this approach might be a useful adjunctive therapy for patients with uncontrolled hypertension.

ROX Medical to present at The Leipzig Interventional Course 2015

San Clemente, CA | December 4, 2014

ROX Medical will participate in The Leipzig Interventional Course (LINC) January 28 & January 29, 2015 in Leipzig, Germany.  On Wednesday, January 28, Dr. Paul Sobotka will present "Treatment of resistant hypertension by creation of an AV anastomosis: the pathophysiologic basis and principle of treatment" during the session "Catheter-based treatment of hypertension - where do we stand, where do we go?" which will be chaired by Dr. Felix Mahfoud. The session begins at 8:00 a.m. and Dr. Sobotka is scheduled to speak at 9:30 a.m.  Additionally, on Thursday, January 29, Dr. Sobotka will also present during the "Latest insights from cardiovascular clinical trials" session.  Dr. Sobotka's presentation is entitled "Review of the results of the European, randomized trial of AV anastomosis with the ROX coupler for resistant hypertension."  Dr. William Gray will chair this session beginning at 1:30 p.m.
For more information, please visit the LINC programme or contact ROX Medical for more information at: 

ROX Medical presents positive data for CONTROL-HTN resistant hypertension trial

San Clemente, CA | September 16, 2014

ROX Medical presented positive results from the CONTROL-HTN trial, an international multi-center, prospective, randomized, controlled, blinded endpoint study of the ROX Coupler for the treatment of arterial hypertension, at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting in Washington, DC. The CONTROL-HTN trial, NCT01642498, evaluated 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 reduction of blood ambulatory blood pressure and office pressure at 6 months post procedure as well as the safety and efficacy of the ROX Coupler.

ROX Medical completes enrollment in CONTROL-HTN trial

San Clemente, CA | April 14, 2014

ROX Medical 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 adds 15th Clinical site, in Netherlands, to CONTROL-HTN randomized study

San Clemente, CA – April 23, 2013

ROX Medical this week received confirmation of Ethics Committee approval at St. Antonius Hospital, Netherlands making it the 15th clinical center in the ROX CONTROL-HTN randomized study. St. Antonius will join centers across the UK, Belgium, Ireland, Germany, Poland and Greece. The CONTROL-HTN randomized study is a 100 patient trial to evaluate the ROX arterio-venous Coupler used along with standard drug therapy to treat resistant hypertension. The study is over 25% enrolled and is projected to complete enrollment before year-end.

ROX Medical Enrolls First Patient in Randomized Controlled Hypertension Trial of AV-Coupler

San Clemente, CA - October 18, 2012

ROX Medical announced the first patient enrollment in the CONTROL-HTN international randomized controlled trial of the ROX FLOW procedure for the treatment of resistant hypertension (high blood pressure). The first patient was enrolled at the Universitair Ziekenhuis Brussel (University Hospital of Brussels) Brussels, Belgium by Professor Danny Schoors and Dr Sofie Brouwers. 

Dr. Sofie Brouwers presents the ROX COPD/HTN data at Austin Doyle Award Session at ISH 2012, Sydney, Australia

San Clemente, CA - October 3, 2012

Dr. Sofie Brouwers from UZ Brussel, Belgium was selected to present at the prestigious Austin Doyle Award Session during the 2012 International Symposium of Hypertension (ISH) in Sydney, Australia. Dr. Brouwers presented the 12-month data from the ROX Medical US IDE and German Multicenter study on patients with concomitant COPD and Hypertension. The resulting data explored the associated blood pressure reduction after the creation of an iliofemoral fistula. The data showed that the creation of a calibrated iliofemoral AVF significantly reduced blood pressure after 3 and 6 months and that the reduction was maintained at 12 months.

Read the abstract here:  2012 ISH Austin Doyle Award Session

ROX Medical Announces First Clinical Use of the ROX FLOW Procedure for the Treatment of High Blood Pressure in Resistant Hypertension Patients

San Clemente, CA - October 31, 2011

ROX Medical, Inc. today announced the first clinical use of the ROX COUPLER TM at the Universitair Ziekenhuis Brussel (University Hospital of Brussels) to treat resistant hypertension. "We are pleased to have performed the first ever ROX FLOW Procedure for this new approach to hypertension, the acute impact on the patients blood pressure was greater than we expected and we look forward to understanding how much these patients benefit from the treatment over time."