Two doctors at MUSC Health have become the first in 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 in a patient.
The technology, a device called Barostim, received breakthrough device approval from the U.S. Food and Drug Administration in 2019 after successful trials led by MUSC Health cardiologist Dr. Michael Zile. The device uses electrical impulses to stimulate the nerve regulating blood pressure, causing blood vessels to relax, and blood pressure to drop.
The original method of implantation required a vascular surgeon to make an incision in the patient’s neck to insert the electrode. But the new method would enable the device to be implanted through a wire using ultrasound guidance.
Vascular surgeon Dr. Jean Marie Ruddy and cardiac electrophysiologist Dr. Anne Kroman, both women in heavily male-dominated specialties, acted as principal investigators for studies using the procedure. Ruddy was principal investigator at the MUSC site for the trial of the new implantation method for Barostim, and Kroman is site co-principal investigator for the implant study using the new Barostim system.
“This is what we call a ‘first-in-man study,” Ruddy said. “It’s a new way to deliver the same technology but to save the patient from an incision in the side of the neck.”
The device cannot reverse heart failure, but it can improve patients’ quality of life, according to MUSC cardiologist Dr. Ryan Tedford, section chief of heart failure and director of cardiac transplantation. Tedford’s patient was the first at MUSC Health to undergo the implantation. The patient is doing well after a week of recovery.
“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,” a spokesperson with CVRx, the company that created Barostim, said in a press release. “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.”
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