Healthcare Industry News: deep brain stimulation
News Release - May 17, 2007
CVRx(R), Inc. Appoints Todd Langevin Senior Vice President of Clinical and Commercial DevelopmentIndustry Veteran Brings 20 Years of Medical Technology Experience
MINNEAPOLIS--(HSMN NewsFeed)--CVRx, Inc., a private medical device company, has named Todd Langevin senior vice president of clinical and commercial development, effective immediately. Langevin is overseeing the pivotal clinical trial of the Rheos(TM) Baroreflex Hypertension Therapy(TM) System, the only implantable device designed to control hypertension, a leading cause of heart and kidney disease, stroke and death.
"We are thrilled to have Todd join the CVRx team," said Nadim Yared, president and CEO of CVRx. "Todd's track record of accomplishments and deep medical device background make him well suited for this position. He has the leadership skills and acumen to move the Rheos Pivotal Trial forward."
Langevin brings 20 years of medical device experience to CVRx. He previously held several positions leading businesses within Medtronic. Most recently, he served as vice president and general manager of Medtronic's Movement Disorders business, which includes deep brain stimulation products for treating Parkinson's disease, essential tremor and dystonia; and the SynchroMed pump for delivery of intrathecal baclofen for spasticity.
For five years, Langevin managed sales, marketing and customer education for Medtronic's Neurological business in Europe. Prior to his European assignment he had global market development responsibilities for an implantable spinal cord stimulator for chronic pain, and led a team which developed and launched novel therapies for the treatment of movement disorders. He also held clinical and regulatory positions at Medtronic.
"There's tremendous potential value to the hypertension therapy CVRx has developed because many people are unable to control their high blood pressure through medication," said Langevin. "I'm excited to be part of CVRx."
Langevin received a bachelor's degree in biology from the University of Minnesota and an MBA from the University of St. Thomas.
About the Rheos System and Pivotal Trial
The Rheos System provides a "physio-rational" method to reduce blood pressure. The system's proprietary technology uses the body's own natural blood pressure regulation system (the baroreflex) to control blood pressure.
CVRx received investigational device exemption (IDE) approval from the Food and Drug Administration to begin a U.S. pivotal clinical trial that is evaluating the safety and effectiveness of the Rheos System. The trial is enrolling 300 patients at multiple clinical sites in the United States and in Europe. Visit www.rheosstudy.com or call (866) 543-6434 to learn more about the Rheos Pivotal Trial and participant qualifications.
Preliminary data from European and U.S. early clinical trials evaluating the safety and clinical effectiveness of the Rheos System were presented in a Late-Breaking Emerging Technologies Session at the recent American College of Cardiology conference. The findings showed a significant reduction in blood pressure in patients with drug-resistant hypertension who have a systolic blood pressure of 160 mmHg or greater, despite being on at least three anti-hypertension medications, including a diuretic.
High blood pressure, also referred to as hypertension, affects about 72 million people in the United States alone.(1) Hypertension causes an estimated one in every eight deaths worldwide. Each incremental increase of 20 mmHg in systolic blood pressure or 10 mmHg in diastolic blood pressure above normal levels is associated with a two-fold increase in death rates from stroke, coronary heart disease and other vascular causes. Approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications.(2),(3)
About CVRx, Inc.
CVRx, Inc., is a private company founded in 2001 and headquartered in Minneapolis. Its senior management and technical teams have many years of experience commercializing implantable medical devices. For more information on CVRx visit www.cvrx.com .
This month, CVRx completed a fourth round of private equity financing, totaling $65 million. Johnson & Johnson Development Corporation was the lead investor. Other participants in this round included new investor BBT Fund L.P., and existing investors New Enterprise Associates, Thomas Weisel Healthcare Venture Partners, InterWest Partners, ABS Ventures, Frazier Healthcare Ventures and SightLine Partners. With this financing, the total investment in CVRx exceeds $125 million.
(1) Heart Disease and Stroke Statistics. American Heart Association - 2007 Update.
(2) U.S. Renal Data System. USRDS 2003 Annual Data Report. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2003.
(3) Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002;360:1903-1913.
CAUTION: CVRx Rheos System is an investigational device and is limited by Federal (or United States) law to investigational use only.
CVRx, Rheos, Baroreflex Hypertension Therapy are trademarks of CVRx, Inc.
Issuer of this News Release is solely responsible for its
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