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Lutonix Paclitaxel-Coated Balloon · 2 trials · 2 indications
Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient.
| Arm | Type | Description |
|---|---|---|
| Lutonix Catheter | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Lutonix Paclitaxel-Coated Balloon | DEVICE | Percutaneous transluminal coronary angioplasty (PCTA) |
Inclusion Criteria: * Male or non-pregnant/non-breast feeding Female ≥ 18 years of age. Women of childbearing potential must have a negative pregnancy test (within 7 days of the procedure); * Documented stable angina pectoris Canadian Cardiovascular Society Classification (CCSC) 1-4, unstable angin...
Lutonix Paclitaxel-Coated Balloon is used for treating coronary artery stenosis and in-stent restenosis. It is a drug-coated balloon catheter designed to deliver paclitaxel to the vessel wall during angioplasty. The device is currently in clinical development for these cardiovascular indications.
Lutonix Paclitaxel-Coated Balloon is developed by Becton, Dickinson and Company, traded on the New York Stock Exchange under the ticker BDX. The company is conducting clinical trials to evaluate the device for coronary artery stenosis and in-stent restenosis.
Lutonix Paclitaxel-Coated Balloon is in Phase 1 clinical development. It is an investigational device and has not been approved by the FDA. Two Phase 1 trials have been completed, with a total enrollment of 41 participants across the studies.
Lutonix Paclitaxel-Coated Balloon has two completed Phase 1 trials: NCT00916279, the PERVIDEO I Registry for coronary in-stent restenosis with 41 participants in Belgium, Germany, and the Netherlands, and NCT00934752, a pilot study for coronary de novo lesions with 24 participants in the Netherlands.
Lutonix Paclitaxel-Coated Balloon is a specific paclitaxel-coated balloon catheter developed by Becton, Dickinson and Company. It is designed to deliver paclitaxel to coronary arteries during angioplasty procedures. The device is being studied for coronary artery stenosis and in-stent restenosis.