Sorin Group Announces FDA Approval of New Defibrillation Leads Range: ISOLINE(TM) - 500 Beiträge pro Seite

[MagicWeasel]

Sorin Group Announces FDA Approval of New Defibrillation Leads Range: ISOLINE(TM)
(Business Wire 03.07 12:06:01)

Business Editors / Health Editors

DENVER--(BUSINESS WIRE)----
ELA Medical Inc., a Sorin Group company (MIL:SRN), announces the
U.S. Food and Drug Administration\'s approval to market ISOLINE(TM)
(1), its latest generation of defibrillation leads.

Leads are insulated wires inserted through the vein as part of an
implantable cardioverter defibrillator (ICD) or a pacemaker system.
They are a key component of the implanted system. Connecting the
device to the heart, the leads carry high voltage and electrical
impulses from the implanted device to the heart when needed by the
patient.

The ISOLINE(TM) defibrillation leads have a multi-lumen structure
with a silicone body and include an ETFE protective coating placed
around the cables leading to the electrodes. This redundant
insulation(2) is also made by a third layer of protection consisting
of a polyurethane overlay to provide better abrasion resistance. Both
ends of the defibrillator electrodes are securely connected to the
cables.

Abrasion resistance materials such as polyurethane have much
better(3) friction coefficients than other materials such as silicone.
Avoiding lead abrasion is very important to maximize leads longevity
and protect patients\' safety. Results in an internal study
demonstrated that a similar lead with the same polyurethane overlay
was at least 201 times more resistant to abrasion than a
non-polyurethane coated lead.

\"ISOLINE(TM)\'s FDA approval is a big step towards strengthening
our position in the US market and offering a Cardiac Rhythm Management
complete solution to patients and physicians\", said Fred Hrkac,
President of Sorin Group\'s Cardiac Rhythm Management (CRM) division.

[Loserin]

Antwort auf Beitrag Nr.: 33.577.421 von MagicWeasel am 07.03.08 12:34:52

Das ihr Euren Dummpushversuche immer anbieten müsst wie Sauerbier

[MagicWeasel]

Antwort auf Beitrag Nr.: 33.577.464 von Loserin am 07.03.08 12:38:59

wo liegt Dein Problem?

Geh doch short, wenn Du meinst es ist ein Dummpushversuch.

Wohl noch nie was von einer FDA-Zulassung gehört.
Und die Meldung ist noch keine 20 Minuten alt.