Implant May Provide New Hope for Heart Failure Patients

Thirty-three percent of adults in the United States over the age of 20, and 53 percent of nursing home residents have hypertension (high blood pressure), according to the most recent CDC (Centers for Disease Control and Prevention) data. That’s a whopping $69.4 billion each year in healthcare costs, and with an aging population and increased cases of cardiovascular disease, it’s likely that figure will increase.

Moreover, 30 percent of hypertension patients are treatment-resistant, which means their high blood pressure can’t be brought under control with drugs. But a new Baroreflex Activation Therapy may hold some hope for heart failure and drug-resistant hypertension patients, as well as making a significant dent in drug related healthcare costs.

The baroreflex is the mechanism in the body which regulates circulation and blood pressure. In a healthy individual the baroreflex reacts to abnormally high or low blood pressure by signaling to the brain to lower or increase the heart rate. In those suffering from heart failure and hypertension, the baroreflex mechanism stops working properly.

For these individuals, the Baroreflex Activation Therapy (BAT) device—pioneered by CVRx, a privately held medical device company in Minneapolis, MN—can save or extend life. The device—called the Barostim neo—is implanted into the chest and sends electrical pulses which trick the body into thinking that blood pressure has spiked. In response, the brain sends out regulators that lower the heart rate and bring blood pressure back to normal.

As a Class III medical device, the Barostim has to stand up to stringent FDA regulation and is currently at its investigational stage undergoing trials in Europe and the U.S. The initial trials are showing that Baroreflex Activation Therapy significantly reduces blood pressure in patients with resistant hypertension who are already on several high blood pressure medications, but more research needs to be done.

To meet compliance regulations and quality standards CVRx utilizes PTC’s Integrity.

(Read the full case study).

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