News | August 21, 2009

WorldHeart Receives U.S. Clinical Study Approval for the Levacor VAD

August 21, 2009 - World Heart Corp. said today it received FDA conditional approval to begin a bridge-to-transplant (BTT) study of the Levacor Ventricular Assist Device (VAD) at 10 U.S. centers.

The company is required to provide some additional information to the FDA within 45 days, but the study is permitted to begin upon receipt of clinical center Institutional Review Board (IRB) approvals. WorldHeart has been working closely with a number of clinicians and clinical sites that are interested in participating in the Levacor Study.

Center expansion beyond the initial 10 sites will be based upon a supplemental IDE application and subsequent FDA approval. Study enrollment will involve approximately 200 subjects, with an opportunity to demonstrate statistical significance through a planned interim analysis at approximately 150 subjects.

The Levacor VAD is the only bearingless, fully magnetically-levitated, implantable centrifugal pump to enter clinical trials. The pump uses magnetic levitation to fully suspend the spinning rotor, its only moving part, inside a compact housing. The company said full magnetic levitation eliminates dependence on blood properties for rotor suspension, as well as wear within the pump. This design is expected to optimize blood compatibility by providing unobstructed clearances around the rotor, across a wide range of operation.

For more information: www.worldheart.com

Related Content

The LivaNova Heater-Cooler System 3T helps open heart surgery patients, but can pose an infection risk if not properly cared for.

The LivaNova Heater-Cooler System 3T helps open heart surgery patients, but can pose an infection risk if not properly cared for.

News | Cardiovascular Surgery | February 27, 2020
February 27, 2020 — The U.S.
Michigan Hospital Improves Post-CABG Outcomes Using Proactive Amiodarone Protocol
News | Cardiovascular Surgery | October 23, 2019
Proactive administration of amiodarone to patients recovering from a common heart surgery shows promise in preventing...
Gore Block Grant Supports SVS Quality Programs
News | Cardiovascular Surgery | October 17, 2019
W. L. Gore & Associates Inc. will support a new Society for Vascular Surgery (SVS) initiative to advance patient...
Heart and Lung Surgery Patients May Be at High Risk for Opioid Dependence

Image courtesy of the American Heart Association

News | Cardiovascular Surgery | August 22, 2019
The amount of opioids prescribed for patients after heart and lung surgery has a direct relationship with the risk for...
Keck School of Medicine Promotes Patient Diversity in Cardiac Surgery Clinical Trials
News | Cardiovascular Surgery | July 26, 2019
A highly competitive $4.5 million grant from the National Institutes of Health (NIH) National Heart, Lung and Blood...
Google Doodle Celebrates Coronary Artery Bypass Graft Pioneer René Favaloro
News | Cardiovascular Surgery | July 12, 2019 | Jeff Zagoudis, Associate Editor
Internet search engine giant Google unveiled a new Doodle on its homepage Friday, July 12, celebrating the life and...
Open Heart Surgery Outperforms Stents in Patients With Multivessel Disease
News | Cardiovascular Surgery | May 03, 2019
Coronary artery bypass grafting (CABG) surgery may be the best treatment option for most patients with more than one...
SherpaPak Cardiac Transport System Cleared for Pediatric and Small Donor Hearts
Technology | Cardiovascular Surgery | February 01, 2019
Paragonix Technologies Inc. recently received clearance from the U.S. Food and Drug Administration (FDA) for a design...
Transplanting Pig Hearts Into Humans One Step Closer. A pig heart, shown here, is very similar in size and anatomy to a human heart. For this reason, pigs are used extensively in pre-clinical animal testing for new implantable cardiovascular devices. If pig hearts could be used for human transplantation, it would greatly alleviate shortages of donor human hearts.

A pig heart, shown here, is very similar in size and anatomy to a human heart. For this reason, pigs are used extensively in pre-clinical animal testing for new implantable cardiovascular devices. If pig hearts could be used for human transplantation, it would greatly alleviate shortages of donor human hearts.

News | Cardiovascular Surgery | December 11, 2018
The scientific journal Nature recently published an article from Munich University Hospital which describes the long-...
Overlay Init