Singapore, Aug 17, 2010: UK-based medical technology company, ClearStream Technologies, has received approval from the Pharmaceuticals and Medical Devices Agency, Japan (PMDA), to sell its advanced percutaneous transluminal angioplasty (PTA) balloon catheters in the country. It will be sold under the brand names SLEEK and Savvy Long PTA Balloon Dilation Catheters.
The catheters are to be marketed by Cordis, a worldwide leader in interventional vascular technology. The approval is for the full range of the products’ balloon sizes and is said to 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.
According to the company, the SLEEK Balloon is one of the first .014” guidewire compatible rapid-exchange (Rx) balloons fully dedicated to infrapopliteal vessels.
Mr Andrew Jones, CEO, ClearStream said, "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 US".
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