Des Moines, IA – June 22— Mercy Medical Center – Des Moines and Iowa Heart Center is one of seven centers in the U.S. conducting a study to evaluate a novel device to help lower high blood pressure. An Iowa Heart Center cardiologist was the first in Iowa to implant the device on May 6 at Mercy.
The CALM-FIM_US study is evaluating the MobiusHD™ device, a catheter-delivered implant permanently placed in the carotid artery of the neck. It is designed for patients with treatment-resistant high blood pressure, also known as resistant hypertension, which occurs when a person’s blood pressure remains high (160 mmHg or greater) despite taking at least three different medications to lower it. CALM is an abbreviation for “Controlling And Lowering Blood Pressure with the MobiusHD™” - a prospective multicenter safety study.
“High blood pressure continues to grow in Iowa, the U.S. and worldwide,” said Iowa Heart Center cardiologist Magdi Ghali, M.D., and principal investigator of the trial at Mercy. “Despite advances in medical therapy, a growing number of patients suffer from drug resistance and this population has very few options available to regulate blood pressure once they have failed multiple medications.”
The minimally invasive procedure uses a catheter the size of one typically used in a cardiovascular procedure. It is advanced through a small puncture in the groin and threaded into the carotid artery.
Once there, the catheter delivers a metal implant into the carotid sinus, and the implant is designed to increase the signals generated by the surrounding arterial baroreceptors. Baroreceptor nerve signals detect the pressure of blood flowing through them and send messages to the central nervous system to regulate blood pressure.
“Hypertension significantly increases risk of heart attack, stroke and kidney failure, so controlling it is vitally important,” said Dr. Ghali. “Mercy and Iowa Heart Center are excited to participate in this study and evaluate this device, as it may represent a life-changing treatment option for patients with resistant hypertension.”
The CALM-FIM_US study is sponsored by Vascular Dynamics, Inc. and is a prospective, open-label, multicenter, first-in-man trial. For more information about the trial at Iowa Heart Center, please call (515) 633-3845. Caution: Investigational device – limited by United States law to investigational use.
About Iowa Heart Center
Iowa Heart Center, one of the nation’s premier cardiovascular medicine practices, is an integrated service of Mercy Medical Center—Des Moines, which operates nine offices and more than 30 outreach clinics across Iowa. For more than 40 years, Iowa Heart Center physicians and staff have provided world-class heart and vascular care and disease prevention services to Iowans and their families. Iowa Heart is also involved in clinical research at the national and international level of emerging medical technologies.
About Mercy Medical Center – Des Moines
Mercy operates two hospital campuses, along with more than 20 additional facilities that house more than 50 primary care, pediatric, internal medicine and specialty clinics. Mercy Medical Center – Des Moines is an 802-bed acute care, not-for-profit Catholic hospital founded by the Sisters of Mercy in 1893. Mercy is the longest continually operating hospital in Des Moines and is also one of the largest employers in the state – with more than 7,000 employees and a medical staff of more than 1,000 physicians and allied health associates. Mercy Medical Center–Des Moines is a member of Mercy Health Network and is a part of Catholic Health Initiatives (CHI), a national nonprofit health organization with headquarters in Englewood, Colo. The faith-based system operates in 19 states and includes 105 hospitals and multiple other facilities and services.
About Vascular Dynamics, Inc.
Vascular Dynamics, Inc (VDI), based in Mountain View, California, was one of the nine companies chosen in 2012 by the FDA to participate in the Early Feasibility Study IDE Pilot Program. VDI is conducting clinical trials in the U.S. and Europe to evaluate the safety and performance of the MobiusHD™ device. The CALM-FIM_US Study represents one of the first FDA approvals of an Investigational Device Exemption application (IDE) following the FDA's issuance of draft guidance on IDEs for early feasibility studies. The intent of FDA's guidance is to foster early-stage development of medical devices within the U.S. to address clinical needs and improve patient care, particularly when alternative treatments or assessments are unavailable.