FDA Approval for ReeFlex catheter
13 Septiembre 2010 - 1:00AM
UK Regulatory
TIDMCTN
RNS Number : 5384S
ClearStream Technologies Group PLC
13 September 2010
For Immediate release
13 September 2010
ClearStream Technologies Group Plc ("ClearStream")
FDA approval for ReeFlex catheter
US approval for latest addition to ground-breaking ReeKross catheter range opens
up new opportunities in the world's largest market for peripheral catheters
ClearStream is pleased to announce that it has received approval from the United
States' Food & Drug Administration ("FDA") for its ReeFlex catheter. The ReeFlex
is ClearStream's latest addition to its ground-breaking ReeKross family of
catheters.
The ReeFlex employs a technology similar to the ReeKross, but is modified for
greater flexibility which enables the product to be passed over the aortic
bifurcation, a commonplace procedure that cannot be routinely performed using
the ReeKross. This opens up the potential for the ReeFlex to be used both in a
broader range of procedures and in more markets, such as the USA, where this
technique is the preferred approach for the treatment of peripheral artery
disease (PAD). Like the ReeKross, the ReeFlex is used in the treatment of
extreme cases PAD such as critical limb ischaemia where the lesions in the
vessel have become very heavily calcified. This condition often cannot be
treated using angioplasty catheters of traditional designs and materials because
the lesion is impassable. Untreated, the condition may typically result in the
amputation of the patient's lower limb.
During a recent clinical evaluation Dr Andrew Platts of the Royal Free NHS Trust
Hospital in London said of the ReeFlex: "Smooth crossover of challenging
bifurcations, astonishing performance, outperforms anything I have used so far"
In gaining FDA approval for the ReeFlex, ClearStream has opened up the potential
to supply the largest market in the world for peripheral catheters. The Company
will now engage in an evaluation period with a potential partner for
distribution of the ReeFlex and ReeKross catheters in the USA.
Andrew Jones, CEO of ClearStream commented: "The addition of FDA approval for
the ReeFlex clears the way to negotiate a workable arrangement for the
distribution of both the ReeFlex and the ReeKross in the USA with one of our
partners. Unlike Europe, the predominance of the contralateral approach in the
treatment of PAD in the USA means that FDA approval for the ReeFlex for the
first time opens up the opportunity for the application of this technology to
the treatment of PAD in this market"
-ends-
For further information:
+-------------------------------+----+---------------------+-----+
| ClearStream Technologies | | Tel: + 353 (0) 53 923 |
| Group plc | | 7111 |
+-------------------------------+----+---------------------------+
| Andrew Jones, CEO | | |
| | | |
+-------------------------------+----+---------------------------+
| Winningtons Financial | | Tel: + 44 (0) 117 985 |
| | | 8989 |
+-------------------------------+----+---------------------------+
| Paul Vann | | Mob: +44 (0) 7768 807631 |
| | | |
+-------------------------------+----+---------------------------+
| FinnCap | |
| | |
+-------------------------------+--------------------------------+
| Marc Young, Corporate Finance | Tel: + 44 (0) 20 7600 | |
| Charlotte Stranner, Corporate | 1658 | |
| Finance | | |
| Stephen Norcross, Corporate | | |
| Broking | | |
| | | |
+-------------------------------+--------------------------+-----+
| | | | |
+-------------------------------+----+---------------------+-----+
About ClearStream:
ClearStream, , based in Enniscorthy, Co Wexford, Ireland, is an innovative maker
of medical devices used in interventional procedures, including catheters and
stents. Its products are sold under ClearStream's own brands and are also
supplied to Original Equipment Manufacturers.
The Company is listed on the AIM market of the London Stock Exchange.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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