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How the Rox Flow Procedure Works

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ROX® Medical has developed an implantable device and therapy intended to treat uncontrolled high blood pressure. Blood pressure reduction is achieved by diverting a small amount of blood flow from the arterial system into the venous system.

The ROX Coupler is a small stent-like device that is placed between the artery and vein located in the upper thigh. This allows for a fixed amount of blood to flow between them, known as an anastomosis. The Coupler is about the size of a dime and is easily placed using standard catheter techniques.

The minimally invasive catheter procedure to place the Coupler is called the ROX FLOW procedure. The ROX FLOW procedure is performed in an angiography suite or endovascular catheterization lab under only local anesthesia in about an hour. The ROX Coupler is intended for use in patients with uncontrolled hypertension and may lower blood pressure by shifting a modest amount of arterial blood to the venous system.

Watch the video to view the complete procedure.

ROX Medical is conducting the CONTROL HTN-2 clinical trial in the United States for hypertension (visit www.controlhtn2.com for more information). The ROX Medical Coupler is commercially available in Europe under CE mark.

CAUTION: The ROX® Medical Coupler is an investigational device. Limited by federal (or the United States) law to investigational use only.

roxmedicalusHow the Rox Flow Procedure Works
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Local Cardiologists Evaluate Hypertension-Control Device in National Trial

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This article was written by Ann B. DeBellis of Birmingham Medical News.

Uncontrolled hypertension is a dangerous condition that can lead to heart attack, stroke and even death. According to the Centers for Disease Control, more than 75 million Americans have high blood pressure and only half of them have the condition under control.

Cardiologists in the Brookwood Baptist Health System are participating in a study to evaluate the safety and effectiveness of the ROX Coupler, a new device developed by ROX Medical that may help patients with uncontrolled hypertension.

The CONTROL HTN-2 study is a multi-center, blinded trial that will include up to 30 study sites in the U.S. The first procedure was performed at Princeton Baptist Medical Center in Birmingham by interventional cardiologist Farrell 0. Mendelsohn, MD, a physician partner at Cardiology, P.C.

“Our entire research team at Cardiology P.C. is excited about implementing this research study for our patients. The ROX Coupler technology may offer an alternative option to treat the global problem of uncontrolled hypertension,” says Mendelsohn, the principal investigator for the research protocol.

Physicians at Cardiovascular Associates (CVA) are also participating in the study. Gary S. Roubin, MD, FACC, Medical Director and an interventional cardiologist at CVA, says he and his associates are excited to be a part of evaluating this new technology.

“This is a Food and Drug Administration (FDA) randomized trial, and our patients have the choice of two convenient hospitals in the area and the potential to receive benefits from this trial,” he says.

For the study, half of the participants will receive the ROX Coupler device and the other half will have a procedure to measure imp01tant hemodynamics but will not receive the device.

“The procedure to insert the ROX coupler is simple and quick and has proven to be safe in the hands of qualified interventional cardiologists,” Roubin says. “Patients will be monitored for six to 12 months, and they will not know whether they received the device. Neither will the physicians who are monitoring their blood pressure, so there will be no bias.”

Roubin adds that while the trial participants in the control group won’t have the device, they will receive the most expert care for their blood pressure.

“Should the trial prove to be effective and the device receives FDA approval, the control group members will be given the option of receiving the device at that time,” he says.

Mendelsohn says the procedure is a novel approach to controlling high blood pressure.

“The procedure involves going into both the iliac artery and vein, which run side by side like a railroad track. In the artery, there is a corkscrew-type wire that serves as a target. We then enter the vein and direct a needle from inside the vein into the artery directed at the target wire,” he says. “Once we’ve gone from the vein to the artery with the needle, we pass the wire through the needle so that a wire serves as a track from the vein into the artery. Once the wire is in position between the vein and artery, we insert the ROX Coupler delivery system into the vein and pass it through into the artery. That creates an arterio-venous anastomosis or passageway.”

Mendelsohn likens the shape of the coupler to that of an hour glass.

“We position the hour glass-shaped metallic device partly in the arterial side and partly in the venous side. Then we go back in with a four- millimeter angioplasty balloon and open up the middle pa1t of the hourglass device, which allows high-pressured blood from the iliac artery to go into the lower pressured iliac vein. The procedure takes less than an hour and is performed under local anesthesia.”

Both Roubin and Mendelsohn encourage physicians to talk with their hypertensive patients who might be candidates to participate in the trial. Principal investigators in the Brookwood Baptist Health System include:

Cardiology P.C at Princeton Baptist Medical Center· (205) 780-4330
Dr. Alain Bouchard – Principal Investigator, Hypertension Management
Dr. Farrell 0. Mendelsohn – Principal Investigator, Interventional Cardiology

 

Baptist Princeton has trained about 100 Chinese cardiologists over the past decade through its Chinese Physician Fellowship Training Program. Dr. Farrell Mendelsohn, second from right, is pictured with one of the training groups.

Cardiovascular Associates at Brookwood Baptist Medical Center (205) 510-5000
Dr. Andy Miller – Principal Investigator, Hypertension Management
Dr. Gary Roubin – Principal Investigator, Interventional Cardiology

“This is a fundamental paradigm shift that, I think, can greatly improve the quality of life for patients with difficult-to-control blood pressure. We’ve seen that already in the people we have treated,” Mendelsohn says. “We can offer patients with uncontrolled hypertension something that can drop their blood pressures quickly and significantly. We believe this procedure will improve clinical outcomes dramatically.”

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A New Way to Control High Blood Pressure and Cardiovascular Disease

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National Heart Month is dedicated to spreading knowledge behind Cardiovascular Disease (CVD) because awareness is key. When we know the telltale signs of CVD, we can help ourselves and our loved ones prevent the sometimes deadly side effects from these conditions and seek the correct treatment if needed.

In our last blog post, we discussed who was at risk for CVD and what could be done about it. In addition, we discussed new therapy options for managing uncontrolled high blood pressure which is a leading contributor of Cardiovascular disease. But, all this talk about prevention and treatment begs the important question: Can high blood pressure and cardiovascular disease be controlled?

Chronic Conditions

As a leading cause of Cardiovascular conditions, High Blood Pressure (HBP) can be a lifelong and chronic condition. Chronic conditions are treated much differently than traumatic events in the medical world. Chronic treatment involves targeting the possible root causes of an issue, not simply addressing symptoms. Conditions like CVD and HBP, in order to be controlled, need to define a treatment targeted at the root cause of the issue. Lifelong treatment plans have great success in lengthening the life of the patient, as well as mitigating the negative effects of the specific condition.

For example, when concerning Cardiovascular disease, did you know that you can reduce your risk of death by 30% by addressing your high blood pressure? Studies show that with 1mmHG reduction of blood pressure, the relative risk of cardiovascular disease and death is reduced by 2%. So, reducing your blood pressure by 15mmHg could reduce your risk of cardiovascular disease or death by 30%! And all of this is because you are addressing high blood pressure.

Do Normal Protocols Control HBP?

However, addressing high blood pressure also comes with challenges. Normal protocols for high blood pressure suggest various forms of treatments:

  • Multiple medications
  • Daily exercise
  • Low sodium diet
  • Stress management

While the above protocols certainly address some of the daily pain and symptoms that can occur with high blood pressure, sometimes even with changes in lifestyle and adhering to your medication regime, you still may experience high blood pressure. Often times individuals are prescribed up to three or more medications yet still see their blood pressure readings too high. When this happens, a solution feels out of reach and individuals can feel hopeless and their quality of life decreases while their stress increases.

In order to manage uncontrolled high blood pressure, alternative and new therapies offered through a clinical trial may be the best next step.

Alternative Therapy: The Rox Coupler

At Rox Medical, we are pioneering an alternative therapy designed to manage uncontrolled high blood pressure with our CONTROL HTN-2 Clinical trial (link to clintrials.gov site).

The ROX Coupler therapy is a minimally invasive medical device procedure performed in an angiography suite or hybrid operating room. The procedure takes about an hour and is performed under local anesthesia. The ROX Coupler is placed between the artery and vein in the upper thigh to allow a fixed amount of blood to flow between them, known as an anastomosis. The minimally invasive catheter procedure to place the Coupler is called the ROX FLOW procedure.

The Rox Coupler procedure creates a passage (called an anastomosis) which allows high-pressured blood from the iliac artery to go into the lower-pressured iliac vein in your pelvis. By shifting a modest amount of arterial blood flow to the venous system, individuals with uncontrolled hypertension may contribute to the lowering the blood pressure.

Currently, we are accepting applications for those in the United States who may be eligible to participate in our clinical trial. Find out if you are eligible here.

roxmedicalusA New Way to Control High Blood Pressure and Cardiovascular Disease
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The Heart of the Matter

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February is “heart month” in many senses of the word. Right after the holidays, stores already began stocking up and selling heart candies, balloons, and cards all in preparation for Valentine’s Day. And why wouldn’t they? Love is something worthy of celebration! However, while those red and pink hearts are given to loved ones, they represent an even bigger expression of love we can all give this February: heart health awareness.

February is American Heart Month, in which we can bring awareness of Cardiovascular Disease to our loved ones. Knowing who is at risk for Cardiovascular disease and what measures to take to keep you and your loved ones healthy is the best gift we could ever give to one another.

What is Cardiovascular Disease?Cardiovascular Disease (CVD) is a widespread disease that accounts for one in every 3 deaths in the United States. The most common forms of CVD are heart attack, stroke, heart failure and arrhythmia. These conditions are discussed often, but with good reason. In 2017 alone, CVD was associated with these staggering statistics:

  • An average of 1 person in the United States dies every 40 seconds from CVD
  • CVD claims more lives per year than cancer and Chronic Lower Respiratory Disease combined
  • CVD is the leading cause of global deaths.

How to Reduce Your Risk of Death

These statistics are scary and may serve as a wake-up call to many of us, but there is hope. While CVD may be the leading cause of death globally and in the US, there are tangible things we can all do to change this number.

One of the best ways to reduce your risk of the effects of CVD is to be on top of your numbers and risk for high blood pressure. High blood pressure is a leading, contributing factor to CVD and studies have shown that with 1mmHG reduction of blood pressure, the relative risk of cardiovascular disease and death is reduced by 2%. So, reducing your blood pressure by 15mmHg could reduce your risk of cardiovascular disease or death by 30%!

High blood pressure can be a leading cause of CVD by creating a slow build-up of fat, cholesterol, and other substances that together are called “plaque”, inside the blood vessel walls, making it difficult for blood to pump efficiently to one’s heart. As our arteries harden with plaque buildup, blood clots are more likely to form, all of which point to an increase in CVD. Maintaining a healthy level of high blood pressure is crucial to reducing your risk of CVD as well as many other serious health conditions. In fact, as blood pressure increases, the risks of stroke, heart attack, heart failure and kidney failure also increase.

Who is At Risk and What You Can Do

The truth is, everyone can be at risk for High Blood Pressure, which is one of the reasons your Doctor takes a blood pressure reading at every visit. Regular check-ups by your general practitioner, in addition to knowing your numbers is key to maintaining healthy levels of blood pressure. Factors such as diet, exercise, and stress management are all normal protocols not only in preventing high blood pressure but also reducing it once you’ve been diagnosed. However, high blood pressure is a multi-faceted disease, and not all of your risk factors are within your control: age, genetics, gender and even race can play a role in your risk for developing high blood pressure.

Because the cause of high blood pressure is a multi-layered, complicated, and often hard to pinpoint, we have discovered that normal protocols, while prescribed with good intentions, do not successfully reduce high blood pressure to a level that puts the patient no longer at risk for developing CVD. At Rox Medical, we believe that a medical condition as serious as high blood pressure requires a serious, long-term solution that keeps the many and diverse risk factors in mind.

A New Option to Manage High Blood Pressure

To this end, we are excited to announce that we are in process of developing a new option for managing high blood pressure with a possible long-term solution that may prove to be more reliable and effective than the normal protocols to controlling high blood pressure. In this new therapy, the ROX Coupler, is a small implantable device that creates a passage (called an anastomosis) between an artery and a vein in your pelvis. This passageway allows a small amount of blood to flow from the artery to the vein. Since the blood in the artery is at a higher pressure than the blood in the vein, most patients will experience an immediate reduction in blood pressure.

This minimally-invasive procedure is undergoing current research and development through a clinical trial which will help shape the research that will define the future of high blood pressure treatment. As more patients are able to find an effective and long-term solution to controlling high blood pressure, our hope is that the numbers of deaths and those affected by CVD are greatly reduced. The Rox Coupler therapy has already shown promising results for patients, and we’ve only just begun.

Will you join us in helping reduce the numbers of CVD by participating in our clinical trial that may change the landscape of high blood pressure treatment? Find out if you or someone you know is eligible for participating in our clinical trial and together we can give those we love the gift of a healthier heart.

Reference 1, Reference 2Reference 3Reference 4

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ROX Medical Inc. Announces Sustained Improvements in Patients with Uncontrolled Hypertension Treated with the ROX Coupler

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CONTROL HTN 12-Month Data Published in Hypertension and to be presented at TCT 2017

SAN CLEMENTE, Calif., October 26, 2017 – ROX Medical Inc., a privately held medical device company pioneering an innovative interventional vascular therapy for uncontrolled hypertension, announced the publication of 12-month outcomes of the ROX CONTROL HTN study in the prestigious journal, Hypertension.

CONTROL HTN is a multi-center randomized controlled trial that enrolled patients with uncontrolled hypertension. In the study, at the 12-month follow-up, patients treated with the ROX Coupler had a sustained mean reduction of 25mmHg in in-office systolic blood pressure and a reduction of 13 mmHg in 24-hour ambulatory systolic BP vs. baseline. These results are consistent with 6-month clinical outcomes reported previously in The Lancet, which reported a mean drop of 27 and 13 mmHg in office and ambulatory pressures respectively.

“The magnitude of ambulatory blood pressure reduction at 12 months is striking and establishes a genuine, significant, and durable anti-hypertensive effect,”, said Dr. Melvin Lobo of the Barts NIHR Biomedical Research Centre and lead author of the Hypertension publication. “These compelling clinical benefits suggest that the ROX Coupler has the potential to be a major advance in the treatment of patients suffering from uncontrolled hypertension.”

Rodney Brenneman, Chief Executive Officer of ROX Medical commented, “According to the CDC, more than five million patients in the US with stage 2 hypertension (> 160 mmHg) are not achieving acceptable blood pressure control on available medical therapies. Publication of the CONTROL HTN 12-month outcomes adds to the growing body of evidence for the ROX Coupler as an important new option for patients struggling with uncontrolled hypertension.”
The 12-Month Control HTN data will be included in an oral presentation on the ROX Coupler by Dr. Krishna Rocha-Singh, at the TCT2017 meeting in Denver on Monday, November 30.

ROX Medical is currently enrolling the CONTROL HTN-2 Clinical study, a randomized, sham controlled pivotal trial designed to evaluate the safety and effectiveness of the ROX Coupler used to create an arterio-venous anastomosis in the iliac vessels, in patients with high blood pressure. Dr. Rocha-Singh is the principal investigator for the CONTROL HTN-2 clinical trial. For more information on the CONTROL HTN-2 study, please visit www.controlhtn2.com.

About ROX Medical, Inc.,

ROX Medical is a privately held medical device company pioneering an innovative interventional vascular therapy for Uncontrolled Hypertension. ROX Medical has developed a simple, minimally invasive and reversible procedure that may be performed in under one hour without sedation in a standard vascular catheterization lab. More than 67 million Americans are living with high blood pressure, and 16 million know they have high blood pressure and are receiving medication for it but still don’t have their pressure under control. ROX Medical is conducting additional studies in hypertension and is available commercially in Europe under CE mark.
For more information, visit www.roxmedical.com.

roxmedicalusROX Medical Inc. Announces Sustained Improvements in Patients with Uncontrolled Hypertension Treated with the ROX Coupler
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ROX Medical CONTROL HTN-2 Clinical Trial; First Procedure Performed

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SAN CLEMENTE, Calif., October 3, 2017 – ROX Medical Inc. A privately held medical device company pioneering an innovative interventional vascular therapy for Uncontrolled Hypertension, announced today that the first patient was treated in the CONTROL HyperTeNsion (HTN)-2 clinical study, the Company’s pivotal study to evaluate the safety and effectiveness of the ROX Coupler used to create an arterio-venous anastomosis in the iliac vessels, in patients with high blood pressure.

The CONTROL HTN-2 study is a large, multi-center trial that will include up to 30 study sites in the U.S. The first procedure was performed at Brookwood Baptist Health PRINCETON BAPTIST MEDICAL CENTER in Birmingham, Alabama by Dr. Farrell O. Mendelsohn, Physician Partner at Cardiology, P.C. “Our entire research team at Cardiology, P.C. is excited about implementing this research study for our patients as the ROX Coupler technology may offer an alternative option to treat the global problem of uncontrolled hypertension” said Dr. Mendelsohn, the principal investigator for the research protocol.

Prior to CONTROL HTN-2, ROX Medical conducted a multi-center randomized trial in Europe. Patients treated with the ROX Coupler experienced a mean drop in blood pressure of 27 mmHg which was sustained out to 6 months. A manuscript has been recently accepted for publication confirming a significant and durable pressure drop at one year.

The ROX Coupler and FLOW procedure creates a passage between an artery and a vein in the upper thigh, which redirects a measured amount of arterial blood to the veins. This therapy is intended to reduce peripheral vascular resistance and add a compliant venous element to the arterial system through creation of a therapeutic arteriovenous anastomosis with the ROX Coupler.

Rodney Brenneman, Chief Executive Officer of ROX Medical, Inc., said, “starting the ROX CONTROL HTN-2 study is a crucial milestone in our efforts to help the millions of patients living with uncontrolled high blood pressure manage their disease. We congratulate our colleagues at Brookwood Baptist Health PRINCETON BAPTIST MEDICAL CENTER on being the first to enroll in this important study”.

About ROX Medical, Inc.,
ROX Medical is a privately held medical device company pioneering an innovative interventional vascular therapy for Uncontrolled Hypertension. ROX Medical has developed a simple, minimally invasive and reversible procedure that may be performed in under one hour without sedation in a standard vascular catheterization lab. More than 67 million Americans are living with high blood pressure, and 16 million know they have high blood pressure and are receiving medication for it but still don’t have their pressure under control. ROX Medical is conducting additional studies in hypertension and is available commercially in Europe under CE mark. For more information, visit www.roxmedical.com.

About Cardiology, P.C.,
For over forty years, the physician specialists at Cardiology, P.C. in Birmingham, Alabama have provided the most advanced diagnostic and treatment methods for managing heart and vascular disease and are at the cutting edge of clinical research. For more information, visit www.cardiologypc.com

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

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.

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ROX Medical completes enrollment in CONTROL-HTN trial

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.

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roxmedicalusROX Medical completes enrollment in CONTROL-HTN trial
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