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Shanghai, China - Reewarm? PTX Drug Coated Balloon Dilation Catheter ("Reewarm? PTX"), independently developed by MicroPort Endovascular (Shanghai) Co ("MicroPort? Endovascular"), was recently granted Green Channel status to fast track for China Food and Drug Administration ("CFDA") approval.

Reewarm? PTX is a drug-coated OTW balloon dilation catheter, designed for the treatment of peripheral arterial diseases. The catheter is inserted into a vessel with the balloon assembly in an un-inflated form. The balloon is positioned at peripheral arterial lesion and inflated to open the narrowed vessel. The coated drug paclitaxel is transported to the lesion vessel wall once the inflated balloon touches the arterial wall. Then the balloon is deflated and taken out of the body. The paclitaxel remains on the vessel wall in a certain form over a certain period of time to inhibit the proliferation of smooth muscle cell, so as to prevent the vessel restenosis.

The innovative Green Channel for CFDA approval was an important approach introduced by the government administration to encourage the innovations of medical devices and promote the application of new technologies in the healthcare industry.