FDA approved the Lutonix 035 Drug Coated Balloon (DCB) Catheter (Bard) for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150 mm in length in native vascular disease of the superficial femoral or popliteal arteries ...
CE = Conformité Européenne; DCB = drug-coated balloon; FDA = U.S. Food and Drug Administration. Taken together, because the interaction among the doses, formulations, and release kinetics of the drugs used is important, there is no “class effect” of DCBs. Technical Considerations Choice ...
Drug-coated balloon (DCB) angioplasty is one of the potential approaches to alleviating in-stent restenosis and treating peripheral artery disease. An in-silico model has been developed for sirolimus drug eluted from an inflated balloon in a patient-specific arterial cross-section consisting of fibrou...
The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter has a balloon coated with the drug paclitaxel, which may help prevent re-narrowing of the affected artery after the clearing procedure, the FDA said. The device is approved to clear vessels clogged by Peripheral Artery...
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon产品名称,P160049 S001申请号,PMA申请类型,The Spectranetics Corp.申请人,数据来源于药智数据美国上市器械数据库。
Surmodics, Inc., a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced the receipt of U.S. Food and Drug Administration approval for the SurVeil™ drug-coated balloon.
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recently announced FDA approval of the Lutonix 035 drug-coated balloon percutaneous transluminal angioplasty (PTA) catheter for PTA, after predilatation, of de novo or restenotic lesions up to 150 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4 ...
Engineered to deliver stent-like patency and restenosis prevention with long-term release of two synergistic drugs.
This summary aims to describe the discussions and recommendations made by the advisory panel during the meeting. Based on the Panel's recommendations, it is possible that the FDA will approve this device. 展开 关键词: US Food and Drug Administration Lutonix Drug-coated balloon ...