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Paclitaxel-Coated PTCA Balloon Catheter

2022-11-01

Product Name:  Paclitaxel-Coated PTCA Balloon Catheter


What is it?  The Paclitaxel-Coated PTCA Balloon Catheter uses a drug-coated balloon to re-open blocked or narrowed arteries in the thigh and knee due to peripheral artery disease(PAD). The balloon is coated on its outer surface with paclitaxel ,a drug which may help stop the arteries from narrowing again (restenosis).


How does it work?  A  traditional angioplasty balloon catheter is inserted through the blood vessels, across the blockage or narrowing, and inflated to partially open the blockage or narrowing.  The Paclitaxel-Coated PTCA Balloon Catheter is then used to fully open the narrowed portion of the artery and apply the drug to the artery wall.


When is it used? Paclitaxel-Coated PTCA Balloon Catheter is used when arteries in the thigh and knee are narrowed or blocked as a result of Peripheral artery disease  (PAD). PAD occurs when fatty material builds up in these arteries, which can cause hardening and/or narrowing of the arteries , limiting the flow of oxygen-rich blood to the body. People with PAD may experience lifestyle-limiting symptoms, such as leg pain, or serious complications, including skin ulcers, or gangene.


What will it accomplish?  Paclitaxel-Coated PTA Balloon Catheter will open  up a narrow or blocked artery in the thigh and knee. The drug helps keep the artery open over time. This device was shown to be as safe and more effective than standard balloons with no drug coating. In a clinical study, at 12 months, Paclitaxel-Coated PTCA Balloon Catheter was able to keep 83% of arteries open.


When should it not be used?  Paclitaxel-Coated PTCA Balloon Catheter should not be used in:


  • Patients with known hypersensitivity to paclitaxel (or structurally-related compounds)

  • Patients who cannot receive recommended antiplatelet or anticoagulation therapy

  • Patients who are breastfeeding, pregnant, or are intending to become pregnant

  • Patients intending to father children

  • Coronary arteries, renal arteries, and supra-aortic/cerebrovascular arteries

  • Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system


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