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 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 month’s 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 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.
roxmedicalusROX Medical adds 15th Clinical site, in Netherlands, to CONTROL-HTN randomized study
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 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.
ROX Medical, Inc. today announced the first clinical use of the ROX COUPLERTM 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.”
roxmedicalusROX Medical Announces First Clinical Use of the ROX FLOW Procedure for the Treatment of High Blood Pressure in Resistant Hypertension Patients