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What Women with Hypertension Should Know About Dementia Risks

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Reducing and controlling your high blood pressure long term is more important than ever, especially for women. While hypertension comes with its own life-threatening risks, including heart failure and stroke, researchers are now finding that it can also increase the risk of dementia for women ages 40 and older.

Dementia – Symptoms and the Risk

Dementia is defined as the loss of cognitive functioning, including thinking, reasoning, and remembering to a point that it interferes with a person’s daily life. Anyone who has known someone with dementia understands just how much it affects every aspect of that person’s life, from their day-to-day activities and self-care, to emotions and relationships.

Symptoms of dementia, some of which include memory loss, inability to focus, language problems, and unpredictable behavior, are the result of losing once-healthy nerve cells in the brain. While neuronal loss happens naturally with age, people with dementia experience greater amounts and at a faster rate. Over the past decade, more research is providing insight into the link between high blood pressure and dementia.

A study published last year in the journal Neurology found that the following three characteristics significantly increased the likelihood of dementia by 65 percent:

  • Women
  • Over the age of 40
  • Dealing with uncontrolled hypertension

Even more alarming, women who experienced the onset of hypertension for the first time in their forties had an increased risk of 73 percent. Yet, researchers found no evidence to suggest that men in mid-adulthood with high blood pressure was associated with any heightened risk of dementia.

In an effort to see what was happening behind the scenes in the brain, researcher and neurology professor Dr. Zoe Arvanitakis and her team examined autopsied brains of individuals who had high blood pressure.

“What we wanted to do was look at the actual brain tissue to see whether we saw the underlying changes in the brain that cause stroke or the underlying changes in the brain that cause dementia,” said Dr. Zoe Arvanitakis.

In their study that consisted of two-thirds women, Arvanitakis and her team noticed a higher number of lesions and tangles in the brain tissue — a common sign of Alzheimer’s disease. While their research is ongoing, the findings further support the treatment and control of high blood pressure, especially late in adulthood, to protect against the risk of Alzheimer’s and dementia.

Reduce Your Risk

Today, over 5.7 million Americans are living with Alzheimer’s and someone develops the disease every 65 seconds. Although no one is safe from the threat of dementia, lowering your high blood pressure and controlling it long term can help reduce your risk. Currently, lifestyle modifications and medication therapy are the only approved options to treat hypertension in the United States. However, at Rox Medical, we are pioneering an alternative therapy designed to manage uncontrolled high blood pressure with our CONTROL HTN-2 Clinical trial.

This clinical trial is designed to study the effectiveness of the ROX Coupler, a dime-sized stent placed in the upper thigh, creating a small passageway from the artery to the vein. This minimally invasive procedure and allows high-pressured blood from the iliac artery to flow 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.

By reducing your blood pressure, you could not only lower your risk for dementia, but also for heart attack, stroke, and other hypertension-related illnesses. If you are interested in learning more about the CONTROL HTN-2 Clinical trial, or want to see if you’re eligible to participate, see our requirements here. No one should have to live with the threat of dementia; find out how Rox Medical can provide an alternative option to help loosen the control hypertension has on your life.

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What Causes Hypertension?

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Hypertension is an enigma for many because it’s causes are generally unknown. While there are many risk factors for hypertension, the medical community has yet to be able to determine one exact cause. However, this isn’t all bad news. Because hypertension has many risk factors, it opens up the possibility of unconventional treatment of this chronic disease. We believe that a disease as complicated and nuanced as hypertension is, it requires a multi-faceted and unconventional approach in order to see long-term results.

Acute vs Chronic Causes

High blood pressure can be caused by both acute and chronic causes. An acute cause of high blood pressure may be stress or anxiety, especially in the form of nervousness. Known as “white coat hypertension”, when a person’s blood pressure only rises during a stressful situation, they may diss miss it as merely situational. However, white coat hypertension should not be ignored and is considered an acute cause of high blood pressure. In fact, those prone to white coat hypertension are found to be more susceptible to chronic high blood pressure later in life.

Chronic high blood pressure, on the other hand, has a much wider variety of risk factors and is sometimes thought to be the result of an underlying disease such as kidney disease. Those who are at risk for chronic high blood pressure most fall into one of the following categories:
Usually over 60 years old in age
Being overweight or obese
Other existing health concerns such as high cholesterol levels, diabetes or cardiovascular disease.

However, regardless if you’ve been diagnosed with acute or chronic hypertension, neither one can be ignored. High blood pressure must be addressed because when left unresolved, it can lead to heart attack, stroke, or cardiovascular disease.

When Your Numbers Keep Rising

Many people are treated for hypertension with various forms of medication, yet do not see a significant change in numbers. Many medical professionals will give additional protocols to lifestyle changes that are said to help decrease high blood pressure. These include:

  • Regular exercise
  • Decrease of salt consumption
  • Decrease of alcohol consumption
  • Manage stress
  • Address other underlying medical issues

However, many of these solutions, in conjunction with medication, do not effectively lower blood pressure as a long-term solution. In fact, even if you manage all of the above, you may continue to see an increase in your high blood pressure numbers, or at least a maintenance of your current numbers. These numbers are absolutely crucial to regulate because of the high risk of serious health complications that can and do occur. In fact, every 40 seconds, someone dies of a stroke. So what else can you do to prevent being a statistic if conventional suggestions and medications are not working?

Rox Coupler

The truth is, is that anyone can develop acute or chronic hypertension at any point in their lives. With a risk factor list as long as it is for hypertension, it means that throughout one’s life, different exposure to different risks can help or hinder your blood pressure journey. Currently, lifestyle modifications and medication therapy are only approved options to treat hypertension in the United States. There are clinical trials being conducted that may offer a device solution to managing uncontrolled hypertension. The ROX CONTROL HTN-2 is such a clinical trial and is now enrolling across the country.

The CONTROL HTN-2 clinical trial is designed to study the effectiveness of the ROX Coupler. The ROX Coupler is a dime-sized stent placed in the upper thigh, creating a small passageway from the artery to the vein. This allows a fixed amount of blood to flow between them. The minimally invasive catheter procedure to place the Coupler is called the ROX FLOW procedure.

Reducing your high blood pressure long term also reduces your risk of heart attack, cardiovascular disease or stroke is our unique and interventional procedure called the Rox Coupler.
We have started a clinical trial of the ROX Coupler here in the United States. To see if you are eligible to participate, click here. For more information about the success of the ROX Coupler in Europe, please see our latest press release.

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High Blood Pressure and Stroke: The Connection

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What do high blood pressure and stroke have in common?

Many people believe that high blood pressure only affects one’s heart, and that stroke solely exists as a response to stress on the brain. However, both of these ideas are misconceptions. While in some scenarios they could be true, one of the biggest and most overlooked causes of stroke is, in fact, high blood pressure. Often called the silent killer, high blood pressure does not only affect one’s heart but can lead to life-threatening conditions such as heart failure and stroke.

Reduce Your Risk of Death

Currently, over 75 million Americans suffer from high blood pressure, while over 54% of the Americans who are diagnosed do not have it under control, though they may think they do. If high blood pressure remains uncontrolled, the risk of cardiovascular disease, stroke and death greatly increase. As the heart has to work harder to pump blood in a person who is diagnosed with hypertension, one’s blood vessels to the brain can be damaged or weakened causing them to rupture or leak and ultimately cause a stroke.

Reducing your high blood pressure, even by a little at a time, can decrease your risk of death dramatically. For example, did you know that reducing your high blood pressure by 1mmHg reduces the risk of heart disease and death by 2%? Or, by reducing your high blood pressure by 15mmHg reduces the risk of heart disease and death by 30%?

Reducing your high blood pressure means more than the immediate gratifications of a healthier lifestyle, increased energy, and overall health. Reducing your high blood pressure is, in fact, a matter of life and death. Every 40 seconds, someone dies of stroke. Don’t allow yourself to be one of the victims.

Know Your Numbers

Called the silent killer, high blood pressure insidiously plagues many people without their awareness. When we equate high blood pressure with just anxiety, stress, and even poor eating habits, we only look at a small piece of the puzzle. More often than not, high blood pressure affects people without revealing any symptoms at all. Its silent existence can sneak up causing damage to the heart. resulting in more serious cardiovascular complications such as heart failure, heart attack, and stroke that can quickly lead to death.

The best way to get ahead of high blood pressure is to refrain from diagnosing yourself based on how you may be feeling but instead understand and know your numbers. The guidelines for high blood pressure have recently changed, and it’s important to understand your health in light of these new guidelines:

  • Normal: Less than 120/80 mm Hg;
  • Elevated: Systolic between 120-129 and diastolic less than 80;
  • Stage 1: Systolic between 130-139 or diastolic between 80-89;
  • Stage 2: Systolic at least 140 or diastolic at least 90 mm Hg;
  • Hypertensive crisis: Systolic over 180 and/or diastolic over 120, with patients needing prompt changes in medication if there are no other indications of problems, or immediate hospitalization if there are signs of organ damage.

Receiving regular checkups by your doctor is definitely a must in terms of making sure your blood pressure is under control. However, due to the silent nature of high blood pressure, we strongly recommend purchasing a medical grade high blood pressure monitor to use at home; the small investment will allow you to keep a record over time. Watching and knowing your numbers will be your best indicator for determining you are risk for stroke or sudden death.

Calculate Your Risk

Once you do know your numbers, it is actually possible to Calculate your risk for stroke or cardiovascular complications. Using this risk calculator will help determine if your blood pressure is, in fact, under control. While many Americans are diagnosed with high blood pressure and sometimes being treated by their doctor with multiple medications, their blood pressure remains uncontrolled. If you are on three or more medications, yet your high blood pressure and risk for further complications remain high, it may be time to inquire about alternative therapies to help control your high blood pressure to achieve a long-term solution.

We have developed a new and unique, interventional procedure intended to immediately lower and maintain blood pressure in patients unable to control their hypertension with conventional medications. We are currently in the clinical trial stage but have already seen the success of this procedure in reducing high blood pressure over a 12-month period. This equates to another year of life given back to a person suffering from hypertension.

We are currently accepting applications for our clinical trial. To see if you are eligible for participating in this groundbreaking solution, see our eligibility requirements here. Control your high blood pressure today and increase your chance at a stronger, longer life.

roxmedicalusHigh Blood Pressure and Stroke: The Connection
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Top Ten Myths Concerning High Blood Pressure

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Uncontrolled high blood pressure can be an issue of life and death. Often called the “silent killer”, hypertension can quickly spin out of control and in many cases is the leading cause of stroke. May is High Blood Pressure Education Month, and here at ROX Medical, we believe the best way to be aware is to know the facts about HBP.

While the phrase “high blood pressure” or “hypertension” may be phrases you have heard more than once, there is a lot of misinformation surrounding this medical condition. Knowing the difference between myths and facts regarding high blood pressure could potentially save your life or the life of someone you love.

In the medical field of hypertension, we always stress knowing your numbers, but we believe you must also know your facts. We have made a list of the top ten misconceptions when it comes to high blood pressure and supplied you with the truth, so you can pass this along to your friends and family to help keep them healthy!

Top Ten Myths Concerning High Blood Pressure

MYTH #1: If I only experience elevated blood pressure at the doctor’s office, a condition known as white-coat hypertension, there is no real reason to worry.
FACT: White-coat hypertension should not be dismissed. If white-coat hypertension increases your blood pressure, there is the likelihood that other stressors in your life will do so as well. Doctors suggest to monitor your blood pressure at home, and always get regular check-ups.

MYTH #2: High blood pressure has many symptoms that are easily recognized.
FACT: HBP has little to no symptoms, and is often called the silent killer. Getting regular check-ups is the only way to know if you are at risk.

MYTH #3: If you aren’t stressed out, you won’t have high blood pressure.
FACT: Anyone can develop HBP, no matter their stress level.

MYTH #4: As I take my blood pressure at home and the readings are lower, it’s ok to adjust the dose on my medications on my own.
FACT: It is essential to take your medications exactly as your doctor prescribes, and allow him or her to make any necessary adjustments.

MYTH #5: High blood pressure runs in my family, so there is nothing I can do to prevent it.
FACT: While genetics play a role in a HBP diagnosis, they are not the determining factor. You CAN prevent HBP.

MYTH #6: Diet doesn’t play a role in my high blood pressure.
FACT: Eating a healthy diet is crucial to maintaining a healthy lifestyle, too much sugar can increase the insulin your body produces. Most processed foods contain high levels of sugar and sodium.

MYTH #7: Reducing salt intake can cure my high blood pressure.
FACT: This along with other lifestyle modifications can contribute to lowering HBP. while there is no cure for hypertension there are steps you can take to reduce it.

MYTH #8: High blood pressure has many symptoms that are easily recognized.
FACT: HBP has little to no symptoms, and is often called the silent killer. Getting regular check-ups is the only way to know if you are at risk.

MYTH #9: I can only check my high blood pressure at the doctor’s office.
FACT: With a quality machine, it is possible and encouraged to check your HBP at home!

MYTH #10: I got my blood pressure checked a few years ago and since my diet, weight, and habits have not changed, I don’t need to get it checked again.
FACT: There are many contributing factors to high blood pressure and getting checked regularly at your yearly check-up is a good way to know if your blood pressure is staying within a healthy range.

We have developed an innovative interventional procedure designed to immediately, significantly lower and maintain blood pressure in patients with uncontrolled hypertension. If you have uncontrolled hypertension and take three or more medications, you may be eligible for our clinical trial.

Recent studies show that a person dies from a stroke every 40 seconds. Knowing the facts is crucial to be aware of the risk of high blood pressure, but taking steps to keep it under control can save your life. See if you are eligible for our clinical trial here.

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10 Misconceptions About Clinical Trials Debunked

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When you hear the phrase “clinical trial,” what usually comes to mind? We are aware that the normal discussion around clinical trials that you have heard might be clouded with negative talk, distrust, and hesitation. And when it comes to your health, we completely understand why you would want to explore every question and option before making a choice. But truthfully, so much of the information out there regarding clinical trials are misconceptions based on fear and undocumented ideas.

Clinical trials play a huge role in the advancement of the medical community. When doctors and scientists have a breakthrough idea involving a new treatment that might solve a chronic condition such as high blood pressure, clinical trials offer a safe and controlled environment to evaluate these newly researched and documented procedures. Participation in clinical trials is crucial to the advancement of treatments to help find a cure for many of the chronic conditions that plague our society today.

In an effort to continue to support and stand behind clinical trials, we have put together a list of the top ten misconceptions about clinical trials and the reasons why these hesitations can be put to rest once and for all.

1. I don’t want to be a guinea pig

The word “guinea pig” denotes that the trial is being tested first on you, which is not the case. The procedures and treatments being tested during a clinical trial have been researched, documented, and evaluated to the best of their ability years before they are put into a clinical trial. For all medically approved trials, there is no treatment that you will be signing up for that has not already been vetted and tested for numerous possible outcomes. Your participation in the clinical trial is to develop standard procedures, protocols, and number of success stories in order to put the new medical advancement on the market and available to everyone.

2. Clinical trials are not safe

Clinical trials are always done under the supervision and careful watch of a doctor or team of medical professionals. Just as any other procedure your doctor would administer, clinical trials offer the exact same care, follow-up and patient protocols. Because the medical procedures involved in clinical trials are carefully researched and documented before they are tested, doctors are well informed of possible outcomes, when interventions are necessary, and any type of medication management that may be needed during the trial period.

3. Clinical trials are only for people who need a last resort

Clinical trials can help find cures, medications, and procedures for a number of different people at various stages of their conditions. Of course, each trial is different, but in general, clinical trials are not only for individuals who have exhausted every other option available to them. In fact, many trials are designated to helping stop a condition before it gets worse. Most trials have eligibility requirements in which you can learn if the trial is right for you.

4. There are no Doctors involved in clinical trials, only corporations

While many medical corporations and companies fund the research behind clinical trials, they are not trained to carry out the treatments. In order for a clinical trial to be successfully tested, these medical companies rely on the teamwork and expertise of doctors to carry out these procedures. Clinical trials simply can not happen if there is no doctor involvement.

 

5. Cost of treatment not covered by insurance

Depending on the trial’s eligibility requirements, most insurance companies cover the cost of routine procedures associated with clinical trials. Be sure to check with your insurance company before you enroll in a clinical trial, but don’t assume it won’t be covered. Many trials offer some sort of reimbursement or assistance for travel and other elements associated with participation in the study. These details will be offered and explained upon enrollment in the trial.

6. I don’t want a randomized treatment done to me, vs a treatment being chosen by my Dr.

Doctors participating in clinical trials stand behind the treatment options that are being tested. Clinical trials in and of themselves are not randomized. Instead, they are well documented and researched medical treatments. The word “randomized” in the context of clinical trials has nothing to do with the medical treatment, and only to do with how participants are chosen within the trial to receive a certain procedure. Keeping a trial group randomized allows for neither the patient or the doctor to know who has received the treatment in the trial which therefore secures unbiased treatment.

7. I have to give up my standard treatment in order to participate

Many clinical trials actually require that you stay on your standard treatment protocol. Because safety is first and foremost during a clinical trial, approved trials and treatments would never recommend you go off medications or protocols during the trial period. A good rule of thumb is to always check with your doctor and be up to date on all of your prescriptions before you submit this information to the clinical trial. Study participants will be receiving the “gold standard” of care from a team monitoring all aspects of their health.

8. The Dr. knows what group I am in and therefore will treat me differently

Most approved trials operate under a blinded, randomized clinical study. This means that neither the patient or the doctor know who is being exposed to the new treatment and who is not. This allows for an unbiased treatment from the doctor to the patient, as well as an unbiased explanation of symptoms on the patient side.

9. The follow-up during the trial period too long and involved. I’d like a quick-fix instead.

The follow-up period for clinical trials is absolutely crucial to determining the outcome of the medical treatment being tested. Not only are designated protocols and procedures crucial to documenting the success of the trial, they are imperative to the safety of all participants.

10. Clinical Trials never work so there is no point in participating

Clinical trials are absolutely crucial to the advancement and development of medical procedures and treatments. They can change many of the chronic conditions that you or your loved ones deal with on a daily basis. Due to the high vetting, research, and study that goes into developing treatments in a clinical trial, most treatment options are put into the testing phase because of the high probability that they will make a large impact for the advancement of medicine.

We strongly believe in the safety and efficacy of clinical trials. Our own clinical trial is designed to manage uncontrollable high blood pressure, a chronic condition that many people across the globe are suffering from. As we recommend before entering any clinical trial, take a moment and go over our FAQs to see if you are eligible and if our trial is right for you.

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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.

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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.

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.

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

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.

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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

roxmedicalusThe Heart of the Matter
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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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