{"id":82606,"date":"2026-07-09T12:05:11","date_gmt":"2026-07-09T12:05:11","guid":{"rendered":"https:\/\/english.saigonbiz.com\/vn\/viscardia-implants-first-u-s-patient-in-recover-hf-pivotal-trial\/"},"modified":"2026-07-09T12:05:11","modified_gmt":"2026-07-09T12:05:11","slug":"viscardia-implants-first-u-s-patient-in-recover-hf-pivotal-trial","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/viscardia-implants-first-u-s-patient-in-recover-hf-pivotal-trial\/","title":{"rendered":"VisCardia Implants First U.S. Patient in RECOVER-HF Pivotal Trial"},"content":{"rendered":"<div>\n<p><em>Milestone in pivotal IDE evaluation of VisONE&#x2122; Synchronized Diaphragmatic Stimulation Therapy for symptomatic heart failure with reduced ejection fraction; FDA Breakthrough Device Designation<\/em><\/p>\n<p>PORTLAND, Ore., July  09, 2026  (GLOBE NEWSWIRE) &#8212; VisCardia, Inc. today announced the first U.S. patient has been implanted in its RECOVER-HF pivotal trial of VisONE&#x2122; Synchronized Diaphragmatic Stimulation (SDS) Therapy, also known as cardiac diaphragm support, a novel investigational therapy for symptomatic heart failure with reduced ejection fraction (HFrEF) that has been granted FDA Breakthrough Device Designation. The implant procedure was\u00a0performed at the University of Pennsylvania by Jarrod Predina, MD, MTR in collaboration with Lee R. Goldberg, MD, MPH, Vice Chair of Medicine and a member of the Advanced Heart Failure and Cardiac Transplant program, and national principal investigator of RECOVER-HF.<\/p>\n<p>&#8220;The first U.S. implant marks a significant milestone for VisCardia and the RECOVER-HF trial, more importantly, for the patients with symptomatic heart failure who continue to need better options,&#8221; said Peter Bauer, Ph.D., President &amp; CEO of VisCardia. &#8220;RECOVER-HF is the pivotal evaluation that VisONE Synchronized Diaphragmatic Stimulation Therapy deserves, and we&#8217;re grateful to Dr. Goldberg and the entire trial team for their leadership in advancing it.&#8221;<\/p>\n<p>Heart\u00a0failure with reduced ejection fraction\u00a0affects millions of patients. For\u00a0symptomatic patients who remain limited\u00a0despite optimized guideline-directed\u00a0medical therapy (GDMT), few therapeutic\u00a0options exist short of advanced\u00a0mechanical support or transplantation,\u00a0particularly for patients who are not\u00a0candidates for cardiac\u00a0resynchronization therapy.<\/p>\n<p>&#8220;VisONE represents a promising and intuitive therapy for the substantial population of heart failure patients who continue to struggle despite optimized medical therapy,&#8221; said Dr. Goldberg. &#8220;By leveraging the diaphragm&#8217;s natural physiologic contribution to cardiac function, VisONE supports the heart without placing any hardware in or on it. RECOVER-HF is designed to rigorously evaluate whether this approach can benefit patients with symptomatic HFrEF.&#8221;<\/p>\n<p>VisONE cardiac diaphragm support is a\u00a0minimally invasive, implantable system\u00a0that delivers precisely timed\u00a0electrical stimulation to a small\u00a0region of the left hemi-diaphragm in\u00a0synchrony with the cardiac cycle. The\u00a0system is implanted laparoscopically\u00a0through a two-port technique. Because\u00a0no hardware is placed in or on the\u00a0heart, patients remain candidates for\u00a0any future device therapy they may\u00a0require, including cardiac\u00a0resynchronization therapy and\u00a0implantable defibrillators.<\/p>\n<p>About the RECOVER-HF Pivotal Trial<\/p>\n<p>RECOVER-HF (NCT06552637) is a\u00a0prospective, multi-center,\u00a0double-blinded, sham-controlled,\u00a0randomized clinical trial evaluating\u00a0VisONE Synchronized Diaphragmatic\u00a0Stimulation Therapy in patients with\u00a0symptomatic HFrEF. Eligible patients\u00a0have NYHA Class II or III heart\u00a0failure, left ventricular ejection\u00a0fraction of 40% or less, QRS duration\u00a0of 130 ms or less, and are on\u00a0guideline-directed medical therapy.\u00a0Primary\u00a0endpoints include change in\u00a0left ventricular end-systolic volume,\u00a0six-minute walk distance, quality of\u00a0life, and safety. The trial is\u00a0enrolling at sites across the United\u00a0States and well recognized international centers.<\/p>\n<p>About VisCardia, Inc.<\/p>\n<p>VisCardia,\u00a0Inc. is a privately held medical device\u00a0company based in Portland, Oregon,\u00a0dedicated to developing minimally\u00a0invasive therapies for the millions of\u00a0patients living with heart failure. The\u00a0company&#8217;s VisONE Synchronized\u00a0Diaphragmatic Stimulation Therapy, also\u00a0known as cardiac diaphragm support, has\u00a0been granted Breakthrough Device\u00a0Designation by the U.S. FDA and is\u00a0currently being evaluated in the\u00a0RECOVER-HF pivotal IDE trial, enrolling\u00a0at up to 30 sites, as the company\u00a0advances toward\u00a0PMA submission. For\u00a0more information, visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=SfBhI6PIrVpaUWclf8xXsVMVmhEYvT--wdFk9f0V7py1ltLpW9x4VZ8wRYQHboj97dXsdbnelBf_aoLvAFoYJQ==\" rel=\"nofollow\" target=\"_blank\" title=\"viscardia.com\">viscardia.com<\/a>.<\/p>\n<p>Media Contact:<br \/>Jennifer Matson<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=BPdtljBqRcv0_GzniqVFeQpYaWQuaYkr04e1yXKOuevbUOG-yNUPmusQwg68nbrVuQdE4I6NT7ky9c4pXR25PFmRmWB2DZlmmbrMB88C8-Y=\" rel=\"nofollow\" target=\"_blank\" title=\"matsonj@viscardia.com\">matsonj@viscardia.com<\/a><\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/YzA1Yjc3ZjktZTAzZS00YzU2LTk4NDgtNjkxMjllNWFjYWQwLTEzMzQ0MTgtMjAyNi0wNy0wOS1lbg==\/tiny\/VisCardia.png\" referrerpolicy=\"no-referrer-when-downgrade\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Milestone in pivotal IDE evaluation of VisONE&#x2122; Synchronized Diaphragmatic Stimulation Therapy for symptomatic heart failure with reduced ejection fraction; FDA Breakthrough Device Designation PORTLAND, Ore., July 09, 2026 (GLOBE NEWSWIRE) &#8212; VisCardia, Inc. today announced the first U.S. patient has been implanted in its RECOVER-HF pivotal trial of VisONE&#x2122; Synchronized Diaphragmatic Stimulation (SDS) Therapy, also [&#8230;]\n","protected":false},"author":1,"featured_media":85254,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[],"class_list":["post-82606","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-people"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.6 (Yoast SEO v21.6) - 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