News | April 21, 2009

First Patients Receive Implants of Heart Assist System Under FDA-Approved Clinical Trial


April 21, 2009 - The Ohio State University Medical Center in Columbus has successfully completed the first two implants of Sunshine Heart's C-Pulse Heart Assist System under a 20-patient clinical trial approved by the FDA.
Benjamin Sun, M.D., chief, division of cardiothoracic surgery and director, cardiac transplantation and mechanical support implanted the C-Pulse systems.
C-Pulse counterpulsation therapy involves a pliable, inflatable cuff that encircles the aorta and reportedly gently inflates and deflates in time to the patient’s native heartbeat.
"It is an honor to have completed the first U.S. implants of the C-Pulse heart assist system," said Dr. Sun. "C-Pulse is highly innovative and implanted with a simple, low-risk minimally invasive surgical procedure. The device has the potential to offer a new therapy option for the treatment of moderate heart failure."
The 20-patient FDA-approved feasibility clinical trial is being undertaken at six U.S. medical institutions: Northwestern Memorial Hospital, The Ohio State Medical Center Jewish Hospital University (University of Louisville), Hershey Medical Center of the Pennsylvania State University, University of Florida School of Medicine and University of Alabama/ Birmingham Medical Center.

For further information: www.sunshineheart.com


Related Content

News | Ventricular Assist Devices (VAD)

October 31, 2023 — Tenaya Therapeutics, Inc., a clinical-stage biotechnology company with a mission to discover, develop ...

Home October 31, 2023
Home
News | Ventricular Assist Devices (VAD)

June 7, 2023 — Magenta Medical Ltd. has announced the initiation of its FDA-approved Early Feasibility Study with the ...

Home June 07, 2023
Home
News | Ventricular Assist Devices (VAD)

March 1, 2023 — Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, today ...

Home March 01, 2023
Home
News | Ventricular Assist Devices (VAD)

November 2, 2022 — For decades, left ventricular-assist devices (LVADs) have extended the lives of people whose hearts ...

Home November 02, 2022
Home
News | Ventricular Assist Devices (VAD)

October 18, 2022 — The U.S. Food and Drug Administration (FDA) is providing updates to the FDA website to include ...

Home October 18, 2022
Home
News | Ventricular Assist Devices (VAD)

August 25, 2022 — The U.S. Food and Drug Administration (FDA) issued a statement that Medtronic, Inc. is recalling ...

Home August 25, 2022
Home
News | Ventricular Assist Devices (VAD)

August 5, 2022 — Black people and women with severe heart failure who might be good candidates for surgery to implant a ...

Home August 05, 2022
Home
News | Ventricular Assist Devices (VAD)

June 23, 2022 — Medtronic, Inc. is recalling a single lot of HeartWare HVAD System batteries due to welding defects that ...

Home June 23, 2022
Home
News | Ventricular Assist Devices (VAD)

June 8, 2022 — The U.S. Food and Drug Administration (FDA) has issued a release stating that Medtronic is recalling the ...

Home June 08, 2022
Home
News | Ventricular Assist Devices (VAD)

April 28, 2022 — The U.S. Food and Drug Administration (FDA) is alerting healthcare providers to the possibility that ...

Home April 28, 2022
Home
Subscribe Now