ClearStream Technologies Group has received approval from Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to sell its advanced percutaneous transluminal angioplasty (PTA) balloon catheters 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 developer and manufacturer of interventional vascular technology.
The approval is for the full range of the products’ balloon sizes and is expected 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 ClearStream Sleek Balloon is one of the first .014” guidewire compatible rapid-exchange (Rx) balloons fully dedicated to infrapopliteal vessels.
ClearStream CEO Andrew Jones said, “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.”