ClearStream Technologies has announced that it has received notification from the Korean Food and Drug Administration of approval of its most advanced percutaneous transluminal angioplasty (PTA) balloon catheters to be sold in Korea under the brand name Sleek PTA Balloon Dilation Catheters.
The Sleek peripheral balloons are to be marketed by Cordis. The approval is for the full range of the product’s balloon sizes and will include the longest PTA balloons currently available on the world-wide market, now available in Korea for the first time – 40 to 220mm lengths. The Sleek is expected to be launched in Korea during 2009 and follows the successful introduction into the USA market in the first half of 2008.
The Sleek Balloon is one of the first .014″ guidewire compatible rapid-exchange (Rx) balloon fully dedicated to infrapopliteal vessels.
Andrew Jones, Chief Executive Officer of ClearStream commented, “We are delighted to have received Korean approval. This is another step forward for ClearStream, in our successful distribution agreement with Cordis, further extending the range of territories in which the product is sold.”