High Blood Pressure Management

Staying informed is key

Understanding your blood pressure

Blood pressure is a measure of the force that your heart uses to pump blood around your body. Keeping a normal level of blood pressure is important to keep your heart and body healthy. If your blood pressure is too high (hypertension), it can increase your risk of cardiovascular disease by putting too much of a strain on your heart and arteries, and the organs they nourish. Your doctor has probably prescribed multiple blood pressure lowering medications in order to significantly reduce your risk of heart attack, stroke or kidney failure.

Hypertension is a problem that affects 1 in 3 adults and is the cause of 1 in every 8 deaths worldwide.^1,2

Understanding your blood pressure measurement

When your blood pressure is taken, two measurements are recorded during a single heartbeat:

• Systolic: the level of pressure when your heart pumps blood through your arteries and around your body
• Diastolic: the level of pressure when your heart is resting before it pumps again
• Blood pressure is measured in millimetres of mercury (mmHg) and is given as two levels. The systolic reading is the first or top number, followed by the diastolic reading, the second or bottom number.

Why is controlling your blood pressure important?

The risk of cardiovascular events such as heart attack, stroke and heart failure goes up as blood pressure goes up. So, you should always maintain your systolic blood pressure below 140 mmHg (or 130 mmHg if you suffer from diabetes). For example, if your systolic blood pressure number is 160 mmHg, then compared with people at 120 mmHg you are at:

• 4 times higher risk of heart attack³
• 4 times higher risk of stroke⁴
• 4 times higher risk of end-stage renal disease⁵
• 2 times higher risk of heart failure⁶

Hypertension VS resistant hypertension. What's the difference? 

Hypertension can usually be treated with medications. Unfortunately, up to 97% of patients who take antihypertensive medications experience drug side effects, and for some people, medications are not enough. Some people take 3 or more medications, including a diuretic, but still struggle to bring their blood pressure closer to a healthy level. Unfortunately, studies show that the addition of a fourth or a fifth medication seldom provides any meaningful additional benefit. ^7,9 

If you consistently have a reading of 140/90 mmHg or higher, despite being treated with at least 3 medications, you might suffer from resistant hypertension. 

References: 
1. The World Health Report 2002. World Health Organization; 2002:58. 2. Wolf-Maier K. JAMA 2003;289:2363-2369. 3. Lewington Sl. Lancet. 2002;360:1903-1913. 4. American Heart Association. Heart Disease and Stroke Statistics - 2007 Update. Page e112. 5. American Heart Association. Heart Disease and Stroke Statistics - 2007 Update. Page e150. 6. American Heart Association. Heart Disease and Stroke Statistics - 2008 Update. Page 21. 7. Tedla YG and Bautista LE. Drug Side Effect Symptoms and Adherence to Antihypertensive Medication, Am J Hypertens. 2015 Dec 7. pii: hpv185. [Epub ahead of print]. 8. Yaxley JP and Thambar SV. Resistant hypertension: an approach to management in primary care. J Family Med Prim Care. 2015 Apr-Jun; 4(2): 193–199. 9. Timbie JW et al. Diminishing Efficacy of Combination Therapy, Response-Heterogeneity, and Treatment Intolerance Limit the Attainability of Tight Risk Factor Control in Patients with Diabetes. Health Serv Res. 2010 Apr; 45(2): 437-456.

Imbalance means greater risk

Your body is controlled by two systems that lead your heart's reaction to different situations. The sympathetic system is responsible for the “fight-or-flight" reaction, which is triggered when you face stressful situations. On the contrary, the parasympathetic system is responsible for “rest and digest" activities, and generally helps your heart and body calm down.

In resistant hypertension, these two parts of the nervous system are imbalanced. Meaning, there is too much sympathetic activity and not enough parasympathetic activity in your body, putting your heart under a lot of stress and your overall health at serious risk.

BAROSTIM THERAPY™ may balance sympathetic and parasympathetic activity

The BAROSTIM NEO™ device has been created for people like you, who need help controlling their resistant hypertension. It is a minimally-invasive implant that may work together with your body, by sending signals that communicate with your brain. These messages activate a natural process that may bring your nervous system back into balance, allowing you to reduce your blood pressure by relaxing your blood vessels, slowing your heart down and reducing fluid accumulation by the kidneys.

The body may respond to BAROSTIM NEO™ by… 

Relaxing the blood vessels:
This makes it easier for blood to flow to the body, reducing excessive blood pressure. 

Slowing the heart down:
This helps the heart work more efficiently. 

Reducing fluid in the body through improved kidney function:
This lowers blood pressure and further reduces the heart's work load. 

Multiple studies have suggested BAROSTIM THERAPY™'s effectiveness in reducing sympathetic activity and in increasing parasympathetic activity.  By doing this, BAROSTIM THERAPY™ has reduced blood pressure in approximately 76% of patients. ¹ Moreover, study results have suggested that using BAROSTIM NEO™ to reduce blood pressure is effective throughout 6 years of follow-up.^2,3 With BAROSTIM THERAPY™, you may reduce your blood pressure, which can reduce your risk of a heart attack, stroke, or heart failure.⁴ 

References
1. Bakris GL, Nadim MK, Haller H, Lovett EG, Schafer JE, Bisognano JD. Baroreflex activation therapy provides durable benefit in patients with resistant hypertension: results of long-term follow-up in the Rheos Pivotal Trial. J Am Soc Hypertens. 2012;6(2):152-158. 2. De Leeuw PW et al. Baroreceptor activation therapy in treatment-resistant hypertension: six years follow-up data. Presentation, ESH, Milan 2015. 3. Hoppe UC, Brandt MC, Wachter R, Beige J, Rump LC, Kroon AA, Cates AW, Lovett EG, Haller H. Minimally invasive system for baroreflex activation therapy chronically lowers blood pressure with pacemaker-like safety profile: results from the Barostim neo™ Trial. J Am Soc Hypertens. 2012;6(4):270-276. 4. Borisenko O et al. Cost-effectiveness of Barostim therapy for the treatment of resistant hypertension in European settings. Journal of Hypertension 2014, 32:681–692. 

A small device that may help your nervous system find balance

The BAROSTIM NEO™ device has been created for people like you, who need help controlling their resistant hypertension. It is a minimally-invasive implant that may work together with your body, by sending signals that communicate with your brain. ^1,2,3 

Multiple studies have suggested BAROSTIM THERAPY™'s effectiveness in reducing sympathetic activity and in increasing parasympathetic activity.  

By doing this, BAROSTIM THERAPY™ has reduced blood pressure in approximately 76% of patients. ¹  

Moreover, study results have suggested that using BAROSTIM NEO™ to reduce blood pressure is effective throughout 6 years of follow-up. ^2,4 

With BAROSTIM THERAPY™, you may reduce your blood pressure, which can reduce your risk of a heart attack, stroke, or heart failure. ⁵ 

References: 
1. Bisognano JD, Bakris G, Nadim M, Sanchez L, Kroon A, Schafer J, de Leeuw P, Sica D. Baroreflex activation therapy lowers blood pressure in patients with resistant hypertension: results from the double-blind, randomized, placebo-controlled Rheos Pivotal Trial. J. Am Coll. Cardiol. 2011;58:765-773. 2. Hoppe UC, Brandt MC, Wachter R, Beige J, Rump LC, Kroon AA, Cates AW, Lovett EG, Haller H. Minimally invasive system for baroreflex activation therapy chronically lowers blood pressure with pacemaker-like safety profile: results from the Barostim neo™ Trial. J Am Soc Hypertens. 2012;6(4):270-276. 3. BAROSTIM NEO system™ reference guide. Available here – Last accessed March 2016. 4. De Leeuw PW et al. Baroreceptor activation therapy in treatment-resistant hypertension: six years follow-up data. Presentation, ESH, Milan 2015. 5. Borisenko O et al. Cost-effectiveness of Barostim therapy for the treatment of resistant hypertension in European settings. Journal of Hypertension 2014, 32:681–692. 

Humanitarian Device Exemption (HDE) Approval

The BAROSTIM NEO ® LEGACY System has received Humanitarian Device Exemption (HDE) status from the Food and Drug Administration (FDA).  This means that in the United States The BAROSTIM NEO® LEGACY System is a Humanitarian Use Device (HUD), or, “a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year".1

Patients who qualify to receive a BAROSTIM NEO ® LEGACY System must meet all of the following criteria:

• Have resistant hypertension
• Have had bilateral implantation of the Rheos® Carotid Sinus Leads Models 1010R, 1010L, 1014L, and 1014R (which have been discontinued and are obsolete)
• Have been identified as responders in the Rheos® pivotal clinical study
• If a patient meets the above criteria, the device is considered as approved by FDA.

Use of the Carotid Sinus Lead Repair Kit is contraindicated in patients with infection at or near the implant pocket region.

CAUTION:
Federal law restricts this device to sale by or on the order of a physician.
Humanitarian Device. Authorized by Federal law for use in the treatment of resistant hypertensive patients implanted with the Rheos CSL leads. The effectiveness of this device has not been demonstrated. 

For more information on Humanitarian Device Exemption, please see here.

For more information on the BAROSTIM NEO ® LEGACY System as a Humanitarian Device Exemption, including labeling and complete safety information, please see here.

References
1.  FDA.gov