Two doctors at MUSC Health are the first at an academic medical center and only the second in the world to use a new, minimally invasive procedure to implant a heart failure treatment device.
Both doctors are women in heavily male-dominated specialties. Vascular surgeon Jean Marie Ruddy, M.D., is principal investigator at the MUSC site for the trial of this new implantation method for Barostim. Cardiac electrophysiologist Anne Kroman, D.O., Ph.D., is site co-principal investigator of the BATwire percutaneous implant study, using the Barostim Neo System.
Barostim won breakthrough device approval from the U.S. Food and Drug Administration in 2019 following successful trials led by MUSC Health cardiologist Michael Zile, M.D. The device uses electrical impulses to stimulate the nerve that regulates blood pressure, inducing the blood vessels to relax.
Although the device can’t reverse heart failure, it can improve patients’ quality of life, said MUSC Cardiologist Ryan Tedford, M.D., section chief of heart failure, medical director of cardiac transplantation and professor in the College of Medicine.
His patient became the first at MUSC Health to undergo the new method of implantation last week and is doing well.
The original method of implantation required a vascular surgeon to make an incision in the patient’s neck to insert the electrode. But in a “feat of engineering,” the new method being tested would enable the device to be implanted through a wire using ultrasound guidance, Ruddy said.
“This is what we call a ‘first-in-man study.” It’s a new way to deliver the same technology but to save the patient from an incision in the side of the neck,” she explained.
“There are millions of patients living with heart failure with reduced ejection fraction in the U.S. who may be able to benefit from Barostim. This new implantation method could eventually be used for most patients who may benefit from Barostim and represents a step forward in the evolution of the therapy to be even more simple to implant,” explained a spokesperson with CVRx, the company that created Barostim.
For more information about the procedure, check out this MUSC Catalyst News Story.
Founded in 1824 in Charleston, MUSC is the state’s only comprehensive academic health system, with a unique mission to preserve and optimize human life in South Carolina through education, research and patient care. Each year, MUSC educates more than 3,000 students in six colleges – Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing and Pharmacy – and trains more than 850 residents and fellows in its health system. MUSC brought in more than $327.6 million in research funds in fiscal year 2021, leading the state overall in research funding. MUSC also leads the state in federal and National Institutes of Health funding, with more than $220 million. For information on academic programs, visit musc.edu.
As the health care system of the Medical University of South Carolina, MUSC Health is dedicated to delivering the highest quality and safest patient care while educating and training generations of outstanding health care providers and leaders to serve the people of South Carolina and beyond. Patient care is provided at 14 hospitals with approximately 2,500 beds and five additional hospital locations in development; more than 350 telehealth sites, with connectivity to patients’ homes; and nearly 750 care locations situated in all regions of South Carolina. In 2021, for the seventh consecutive year, U.S. News & World Report named MUSC Health the No. 1 hospital in South Carolina. To learn more about clinical patient services, visit muschealth.org.
MUSC and its affiliates have collective annual budgets totaling $4.4 billion. The nearly 25,000 MUSC team members include world-class faculty, physicians, specialty providers, scientists, students, affiliates and care team members who deliver and support groundbreaking education, research, and patient care.
CVRx is focused on the development and commercialization of Barostim™, the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. Baroreceptors activate the body’s baroreflex, which in turn triggers an autonomic response to the heart. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit the company’s website.