PMDA Approves ClearStream to Sell PTA
The SLEEK and Savvy Long peripheral balloons are to be marketed by Cordis, a developer and manufacturer of interventional vascular technology.
ClearStream claims that 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.
According to ClearStream, 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 inch guidewire compatible rapid-exchange(Rx) balloons fully dedicated to infrapopliteal vessels.
ClearStream Technologies is a developer and manufacturer of minimally invasive medical devices such as catheters and stents that are used in interventional procedures such as angioplasty. Angioplasty catheters are used to clear blocked arteries and stents are permanently implanted devices used to prevent prolapse of the artery following the angioplasty procedure.
Andrew Jones, CEO of 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 USA."
Will the approval benefit the firms?
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