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 
 
 MSCSFFEFEFSSESU 
 

Clearstream (LSE:CTN)
Gráfica de Acción Histórica
De May 2024 a Jun 2024 Haga Click aquí para más Gráficas Clearstream.
Clearstream (LSE:CTN)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024 Haga Click aquí para más Gráficas Clearstream.