PMDA Approval in Japan
16 Agosto 2010 - 8:00AM
UK Regulatory
TIDMCTN
RNS Number : 1090R
ClearStream Technologies Group PLC
16 August 2010
For Immediate Release
16 August 2010
ClearStream Technologies Group plc
PMDA Approval in Japan for Sleek and Savvy Long Catheters
- further extends Global reach of product range.
ClearStream Technologies Group plc ("ClearStream") announces today that it has
received notification that the Pharmaceuticals and Medical Devices Agency, Japan
(PMDA), has given approval for ClearStream to sell its advanced percutaneous
transluminal angioplasty (PTA) balloon catheters in Japan under the brand names
SLEEK(TM) and Savvy Long(TM) PTA Balloon Dilation Catheters.
The SLEEK(TM) and Savvy Long(TM) peripheral balloons are to be marketed by
Cordis, a worldwide leader in the development and manufacture of interventional
vascular technology. The approval is for the full range of the products' balloon
sizes and will make the world's longest usable PTA balloons (220mm) available in
Japan for the first time. The SLEEK(TM) and Savvy Long(TM) are expected to be
launched in Japan during 2010. This follows a period of significant growth in
the USA market since their introduction in the first half of 2008.
The SLEEK(TM) Balloon is one of the first .014" guidewire compatible
rapid-exchange
(Rx) balloons fully dedicated to infrapopliteal vessels.
Andrew Jones, Chief Executive Officer of ClearStream commented, "We are
delighted
to have received Japanese approval. This is major step forward for ClearStream,
in
our successful distribution agreement with Cordis, further extending the range
of
territories in which the products are sold, to one of the largest and most
highly regulated markets outside of the USA".
For further information:
+-------------------------------+----+------------------------+
| ClearStream Technologies | | Tel: + 353 (0) 53 923 |
| Group plc | | 7111 |
+-------------------------------+----+------------------------+
| Andrew Jones, CEO | | |
| | | |
+-------------------------------+----+------------------------+
| Winningtons Financial | | Tel: + 44 (0) 117 985 |
| | | 6969 |
+-------------------------------+----+------------------------+
| Paul Vann | | Mob: + 44 (0)7768 |
| | | 807631 |
+-------------------------------+----+------------------------+
| FinnCap | | Tel: + 44 (0) 20 7600 |
| | | 1658 |
+-------------------------------+----+------------------------+
| Marc Young | | |
+-------------------------------+----+------------------------+
Charlotte Stranner
Stephen Norcross
About ClearStream Technologies Group plc:
ClearStream Technologies Group plc, 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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