Recently, the Biolimus-coated coronary balloon catheter, an innovative product of Shandong JW Medical Systems Ltd., is approved for marketing by China NMPA.
The Biolimus-coated coronary balloon catheter consists of balloon catheter and drug coating on the balloon. The balloon catheter consists of balloon, distal shaft, transition shaft and proximal shaft, etc. The drug coating contains Biolimus drug and a polyethylene oxide (PEO) carrier at a drug dose of 3 μg/mm2. The product is sterilized by ethylene oxide and for single-use. PEO acts as a carrier to support the adhesion of drug to the balloon surface. The hydrophilic property of PEO and the lipophilic property of Biolimus allow the drug to be released from the balloon surface and transfer to the vessel rapidly.
As an intravascular drug delivery technique, drug-coated balloon is able to release drug at target lesion with therapeutically effective concentration, to solve and treat coronary heart disease intervention and in-stent restenosis. This product is applicable for treatment of de novo coronary artery lesion with vessel diameter of 2.0 mm - 2.75 mm, providing a new option for the patients with de novo small vessel lesion.
The NMPA will strengthen the post-marketing surveillance on the product to protect the patient safety.
In case of any discrepancy, the Chinese version shall prevail.