CVRx gains full FDA approval for hypertension study

MINNEAPOLIS, April 29, 2013 /PRNewswire/ -- CVRx, Inc., a private medical device company, received Food and Drug Administration (FDA) investigational device exemption (IDE) approval, allowing the company to proceed with its hypertension study. The study is evaluating the safety and effectiveness of CVRx's Barostim neo™ in treating hypertension (high blood pressure). The prospective, randomized and controlled study will enroll approximately 310 patients in multiple clinical centers throughout the United States. The study's first two patients were enrolled by Dr. Richard Abben, Cardiovascular Institute of the South, Houma, La. Dr. Abben is the Principal Investigator at this clinical site. Investigators Dr. Mitra Nadim and Dr. Karen Woo enrolled the third patient at the University of Southern California.

Barostim neo is designed to use the body's own natural blood flow regulation system to treat hypertension. The system works by electrically activating baroreceptors, the body's natural blood pressure sensors that regulate cardiovascular function. When the Barostim neo is activated, signals are sent through neural pathways to the brain, which responds by telling the arteries to relax, the heart to slow down and the kidneys to reduce fluid in the body, lowering excessive blood pressure and workload on the heart.

According to Dr. George Bakris, Professor of Medicine and Director of the ASH Comprehensive Hypertension Center at The University of Chicago Medicine, who is affiliated with this study, "Barostim Therapy™ has been studied in more than 500 patients, with promising long-term results. The second generation Barostim neo used in this study is small and easy to place, resulting in short procedure times. We anticipate positive results from this new system." Dr. Bakris is on the Executive Steering Committee for the CVRx pivotal hypertension study.

"Obtaining full FDA IDE approval to commence this study is an important step toward making Barostim Therapy available to treat hypertension patients in the United States," said Nadim Yared, president and CEO of CVRx. "Barostim neo has a strong safety profile and excellent clinical results in European studies1. We anticipate these positive outcomes to continue in this study."

For Potential Hypertension Study Participants
Key study qualifications include failing to reduce blood pressure while on at least four hypertension medications and having a systolic blood pressure greater than or equal to 160 mmHg. Study results are intended to support the premarket approval application (PMA) for Barostim neo to the FDA. Approximately 310 patients are planned to be enrolled in the trial. Individuals who are interested in learning more about the trial should visit www.bloodpressuretrial.com.

About Hypertension
In the United States, hypertension affects 77.9 million people.2 Worldwide, hypertension is estimated to cause one in every eight deaths.2,3 It is a major risk factor for cardiovascular disease, morbidity and mortality. Twenty-five percent of people with hypertension cannot adequately control their hypertension with medications and lifestyle modifications.4 It is a disease that needs new treatment solutions.

About Barostim neo
Barostim neo is a second generation device that uses CVRx-patented technology that is designed to trigger the body's own natural blood flow regulation system to treat hypertension and heart failure. The system works by electrically activating the baroreceptors, the body's natural blood pressure sensors that regulate cardiovascular function. These baroreceptors are located on the carotid artery. When activated by Barostim neo, signals are sent through neural pathways to the brain, which responds by telling the:

• Arteries to relax, making it easier for blood to flow through the body and reducing cardiac exertion;
• Heart to slow down, allowing more time for the organ to fill with blood; and
• Kidneys to reduce fluid in the body, lowering both excessive blood pressure and workload on the heart.

This unique, patented technology has the potential to improve quality of life and reduce health risks associated with hypertension and heart failure, including heart and kidney disease, stroke and death. Other key potential benefits of Barostim neo include the following:

• Can be adjusted to meet each patient's individual therapy needs, making it the only personalized medical device therapy for the treatment of hypertension with a CE marking;
• Is a non-destructive reversible treatment; and
• Provides 100% compliance to treatment, by automatically and continuously activating the baroreflex.

About CVRx, Inc.
CVRx, Inc. is a privately-held company founded in 2001 and is headquartered in Minneapolis. The company has developed the second generation Barostim neo, an implantable system designed to treat hypertension (high blood pressure) and heart failure. In Europe, Barostim neo received CE marking for the treatment of hypertension and is in clinical evaluation for the treatment of heart failure. In the United States Barostim neo is in clinical evaluation for the treatment of heart failure and hypertension. For more information, visit www.cvrx.com.

Editor's Note: Blood pressure is typically recorded as two numbers – the systolic pressure (top number) over the diastolic pressure (bottom number). The systolic pressure is the pressure of blood in the vessels when the heart contracts. Diastolic pressure is the pressure of the blood between heartbeats, when the heart is at rest and is refilling.

Footnotes:

Hoppe UC. J Am Soc Hypertens 2012;6(4):270-276.

Heart Disease and Stroke Statistics. American Heart Association – 2013 Update.

Prospective Studies Collaboration. Lancet 2002;360:1903-1913.

Egan BM, JAMA. 2010;303:2043–2050.

CAUTION: Barostim neo™ is an investigational device and is limited by United States law to investigational use.

CVRx and Barostim neo and Barostim Therapy are trademarks of CVRx, Inc. registered in the United States Trademark Office.