PMDA Approval in Japan16 Aug 2010 08:12
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™ and Savvy Long™ PTA Balloon Dilation Catheters.
The SLEEK™ and Savvy Long™ 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™ and Savvy Long™ 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™ 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
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