PORTLAND, Ore., March 16, 2021 /PRNewswire/ — VisCardia Inc., a privately held medical device developer, announced today that the American Medical Association (AMA) has issued (ten) 10 new Current Procedural Terminology (CPT®) Category III codes in support of the implant procedure and management of Synchronized Diaphragmatic Stimulation (SDS®) therapy as provided through VisCardia’s […]
Tag: VisONE
VisCardia Announces Its Novel Heart Failure Therapy Receives Breakthrough Device Designation From the FDA
PORTLAND, Ore., April 23, 2020 /PRNewswire/ — VisCardia Inc., a privately held medical device developer, announced today it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its implantable VisONE® system designed for the treatment of moderate to severe heart failure with reduced ejection fraction and preserved ventricular […]
VisCardia Announces Completion of Its VisONE Heart Failure Pilot Study
PORTLAND, Ore., March 9, 2020 /PRNewswire/ — VisCardia Inc., a privately held medical device developer, announced today it has completed the company’s First-in-Human study of the implantable VisONE® system for medically refractory heart failure (HF) patients with reduced ejection fraction (HFrEF) and preserved ventricular synchrony. The VisONE Heart Failure pilot was a prospective, […]
VisCardia Announces Completion of Enrollment and Three Month Follow-Up Visits for Its VisONE® Heart Failure Pilot Study
PORTLAND, Ore.–(BUSINESS WIRE)–VisCardia Inc., a privately held medical device developer, announced today it has completed enrollment and three month follow-up visits of the company’s VisONE® implantable system pilot for medical refractory heart failure patients with reduced ejection fraction and preserved ventricular synchrony. The VisONE Heart Failure pilot is a prospective […]
VisCardia Announces First Implant of the VisONE® System for Treating Heart Failure
PORTLAND, Ore.–(BUSINESS WIRE)–VisCardia Inc., a privately held medical device developer, announced today the first implant of the VisONE® implantable system for heart failure, and the commencement of its VisONE Heart Failure pilot study in Ukraine. The VisONE implantable system delivers VisCardia’s proprietary Asymptomatic Diaphragmatic Stimulation (ADS) therapy to improve cardiac […]