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.
ISOLINE(TM) leads are steroid eluting, dual coil defibrillation
leads available in active and passive fixation models. A clinical
trial showed that with a fully isodiametric 7.8 F lead body,
ISOLINE(TM) ensures very good manoeuvrability and overall handling
characteristics. ISOLINE(TM) leads also offer EASYTURN(TM): a quick
lead placement system for positioning the lead and extending the helix
with a single stylet, and Easy Mapping to obtain pacing thresholds
without helix extension.
The ISOLINE(TM) leads family was successfully launched two years
ago in Europe.
For more information on product performance, see the "Sorin Group
CRM Product Performance Report" available on: www.sorin-crm.com.
About the Sorin Group
The Sorin Group (Bloomberg: SRN.IM; Reuters: SORN.MI), a world
leader in the development of medical technologies for cardiac surgery,
offers innovative therapies for cardiac rhythm dysfunctions,
interventional cardiology and the treatment of chronic kidney
diseases. The Sorin Group includes these brands: Dideco, CarboMedics,
COBE Cardiovascular, Stockert, Mitroflow, ELA Medical, Sorin
Biomedica, Bellco and Bellco Soludia. At the Sorin Group 4,500
employees work to serve over 5,000 public and private treatment
centers in more than 80 countries throughout the world.
For more information, please visit our web site: www.sorin.com or
www.sorin-crm.com
(1) Active fixation models: Isoline 2CR5 (58 cm) IJ27U and 2CR6
(65 cm) IJ24U Passive fixation models: Isoline 2CT5 (58 cm) IJ26U
and 2CT6 (65 cm) IJ23U
(2) Redundant Insulation: ETFE coating, Silicone
(3) Scheuer-Lesser, M. et al. Polyurethane Leads, pg 456, PACE
vol. 6, March - April 1983
(HSMN NewsFeed)
