Free Newsletter
Register for our Free Newsletters
Newsletter
Zones
Analysis, Inspection and Laboratory
LeftNav
Assisted/Independent Living
LeftNav
Clinical and Nursing Equipment
LeftNav
Design and Manufacture of Medical Equipment
LeftNav
Diagnostics Equipment, Monitoring and Test
LeftNav
Education, Training and Professional Services
LeftNav
Health Education and Patient Management
LeftNav
Health Estates Management
LeftNav
Healthcare Support and Information Services
LeftNav
Hygiene and Infection Control
LeftNav
IT and Communications in Healthcare
LeftNav
Materials
LeftNav
Medical Device Technology
LeftNav
Research and Development
LeftNav
Safety and Security
LeftNav
View All
Other Carouselweb publications
Carousel Web
Defense File
New Materials
Pro Health Zone
Pro Health Zone
Pro Security Zone
Web Lec
Pro Engineering Zone
 
 
News

First implants placed in US study of minimally-invasive pulmonic valve

Edwards Lifesciences : 21 April, 2008  (New Product)
The first patients were treated in a USA feasibility study using the Edwards Sapien transcatheter heart valve in addressing a congenital condition in which the valve between the right ventricle and the pulmonary artery is nonfunctional.
'We were able to successfully Implant the Edwards Sapien transcatheter heart valve percutaneously in the first three patients treated in this trial. All of the patients are recovering and are expected to go home today,' said Ziyad M. Hijazi, MD, MPH, director of the Rush Center for Congenital and Structural Heart Disease, chief of the section of paediatric cardiology and professor in the departments of paediatrics and internal medicine at Rush University, Chicago, and a paid consultant to Edwards Lifesciences. 'Patients with congenital right ventricular outflow tract problems typically face the burden of multiple open-heart surgeries throughout their lives, either to replace their 'native' diseased valves or, as they age, their bioprosthetic replacement valves. This clinical study will enable physicians to offer a minimally-invasive alternative to symptomatic patients with a failing pulmonary valve conduit, giving them the opportunity to recover and resume their normal activities.'

The US Food and Drug Administration (FDA) conditionally approved the investigational device exemption (IDE) clinical trial in late 2007. The study of 30 patients at three hospitals will enable the collection of safety and effectiveness data, ultimately in support of a commercial approval application.

In this transcatheter valve replacement procedure, the Edwards Sapien bovine pericardial valve is compressed onto a balloon to the approximate diameter of a pencil, threaded through the patient's circulatory system from the leg using the RetroFlex transfemoral delivery system and deployed across the patient's pulmonary valve. The valve replacement is accomplished as a 'beating heart' procedure, without requiring cardiopulmonary bypass or an open-chest incision.

'Edwards is proud to have the opportunity to address this critical unmet patient need and to offer these patients a far less traumatic treatment option,' said Larry L Wood, Edwards' corporate vice president, transcatheter valve replacement. 'This therapy leverages all of our Edwards Sapien valve platform technologies to help these congenital patients via a minimally-invasive treatment alternative.' Edwards' physician partners performed the first US transcatheter pulmonic case on a compassionate basis in December 2005. All of the compassionate cases have been successful.

The Edwards Sapien transcatheter heart valve is also currently being studied in the PARTNER (Placement of AoRTic traNscathetER valves) US pivotal trial for the treatment of patients with severe aortic heart valve stenosis (a narrowing of the aortic valve that restricts blood flow), who are considered to be high risk for conventional open-heart valve replacement surgery.
Bookmark and Share
 
Home I Editor's Blog I News by Zone I News by Date I News by Category I Special Reports I Directory I Events I Advertise I Submit Your News I About Us I Guides
 
   © 2012 ProHealthServiceZone.com
Netgains Logo