New study provides ‘substantial evidence’ paclitaxel-coated devices are safe when treating lower-limb PAD

Medtronic has received FDA approval for its IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter. FDA clears new drug eluting balloon, drug-coated balloon.

Medtronic's IN.PACT 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter.

Research published in 2018 caused many in the cardiology community to shy away from using these devices, and the FDA even issued warnings about their safety. However, new data suggest paclitaxel-coated balloons and stents are safe.