CORDIS Launches ExoSeal(TM) Vascular Closure Device
By Cordis Corporation, PRNEWednesday, May 26, 2010
New Trial Results on ExoSeal(TM) Vascular Closure Device Support its Clinical Safety* and Efficacy
PARIS, May 27, 2010 - Cordis Corporation, a worldwide leader in the development and manufacture
of interventional vascular technology, announced the launch of the
ExoSeal(TM) Vascular Closure Device. ExoSeal(TM) incorporates a number of new
advances in technology and simplicity of design to provide precise and secure
extravascular arterial closure. Cordis Corporation received CE-Marking
approval for ExoSeal(TM) Vascular Closure Device in May 2010. This new
product was launched during EuroPCR, the leading medical conference in Europe
for physicians specializing in interventional cardiovascular medicine.
ExoSeal(TM) was shown in a recent clinical trial to have an excellent
clinical safety* profile during vascular procedures. The 'ECLIPSE Trial'
recorded no adverse clinical events and achieved a level of safety comparable
to manual compression while significantly reducing time to ambulation. The
device has achieved this level of clinical safety by combining easy-to-use
functionality with trusted bioabsorbable technology and precise extravascular
closure.
"We are very pleased to announce the launch of our first Vascular Closure
Device" said Campbell Rogers, M.D., Chief Scientific Officer and Global Head,
Research and Development, Cordis Corporation. "The ExoSeal(TM) Vascular
Closure Device incorporates key advancements including the use of the
Polyglycolic Acid Plug, two visual indicators to moderate control of the
device and lockout features to reduce the risk of complications. The device
is designed for ease of use, reducing the number of components and deployment
steps."
"From our experience in the ECLIPSE trial, we were impressed with the
safety and the effectiveness of this new closure device. It is very easy to
use and nothing is left inside the vessel to threaten arterial blood flow. An
advantage compared to other devices is the procedural sheath does not need to
be changed which helps promote patient comfort. The two visual indicators are
important for positioning the bioabsorbable plug ," explains Marcus Wiemer,
M.D., Primary Investigator, Department of Cardiology, Heart and Diabetes
Center North Rhine-Westphalia, Ruhr University Bochum, in Bad Oeynhausen,
Germany**.
ExoSeal(TM) in detail
The ExoSeal(TM) Vascular Closure Device makes use of key technological
developments to support the clinical safety of the closure procedure. In the
ECLIPSE Trial, the extravascular plug placement was associated with no
embolization, infection or other major adverse events, comparable to manual
compression [despite the significantly shorter time to ambulation for
ExoSeal(TM)]. The bioabsorbable PGA-plug, which is designed to close the
femoral artery puncture site with minimal or no inflammation, is fully
reabsorbed in 60-90 days. PGA (Polyglycolic Acid) is a trusted non-collagen
plug material that is metabolized to carbon dioxide and water. A system of
deployment through the existing procedural sheath makes ExoSeal(TM) quicker
and easier to use and increases physician convenience by minimizing or
eliminating the need for sheath exchange during the procedure. The device
uses visual indicators to help the clinician deploy the device correctly.
This "visual feedback" also promotes patient comfort during deployment and
the 'lock-out' system of ExoSeal(TM) helps ensure that only extra-vascular
plug placement can take place.
Notes to editors:
About the ExoSeal(TM) Vascular Closure Device:
The ExoSeal(TM) Vascular Closure Device is due to be available for the
commercial market in June in Europe. Alongside the ExoSeal(TM) Vascular
Closure Device launch, Cordis will roll out a comprehensive programme of
customer training and certification to ensure that all users are fully
confident in the handling of the device.
About the Eclipse Trial
The safety and effectiveness of the device was assessed in two
non-randomized studies conducted in Mexico and Germany, as well as a study in
the US where the 6F ExoSeal(TM) was compared with manual compression (MC)
with a 2:1 randomisation in patients undergoing diagnostic and interventional
coronary/peripheral procedures. The trials tested the time to hemostasis, the
time to ambulation and the 30-day combined rate of access site-related
complications. The results showed that there were no major adverse events, no
vascular repair, no access site-related bleeding requiring transfusion, no
access site-related infection requiring treatment, no new ipsilateral low
extremity ischemia and no surgery for access site-related nerve injury.
* Clinical data from the ECLIPSE trial indicates safety in terms of vessel injury, access site-related bleeding, infection or nerve injury, new ipsilateral lower extremity ischemia or serious adverse events (SAE). ** In addition to his role as Primary Investigator, Dr. Weimer is compensated for his services as a member of the Company's scientific advisory board and provides other consulting services.
About Cordis Corporation
For more than 50 years, Cordis Corporation, a Johnson &
Johnson company, has been a worldwide leader in the development and
manufacture of interventional vascular technology. Through the company's
innovation, research and development, Cordis partners with interventional
cardiologists worldwide to treat millions of patients who suffer from
vascular disease.
Media Contacts: Isabella Sharp, APCO Worldwide, Tel: +44(0)20-7526-3600, Mob: +44(0)7813307490
Tags: Cordis Corporation, France, May 27, Paris