Lutonix™ 035 Drug Coated Balloon
The Lutonix™ 035 Drug Coated Balloon is part of the Bard portfolio supplied by BD. BD describes the Lutonix™ Drug Coated Balloon PTA Catheter as being offered in 0.018 and 0.035 guidewire configurations for the treatment of de novo, restenotic or in-stent restenotic lesions in the superficial femoral and popliteal arteries. The 035 device is the 0.035″ guidewire configuration within that family. According to BD, the Lutonix™ drug coated balloon delivers a dose of 2 µg/mm² of paclitaxel and is designed to provide the versatility needed to treat lesions of varying sizes and lengths. BD positions the balloon as engineered to enhance femoropopliteal procedures by providing a robust size matrix, extensive indications and proven results in a Level 1 clinical trial. The drug coated balloon approach is intended to deliver an antiproliferative agent to the vessel wall during angioplasty without leaving a permanent implant, an option of interest where a stent is not desired. For interventional and vascular teams in Azerbaijan, the relevant interest is a paclitaxel-coated angioplasty balloon for the femoropopliteal segment. Azmed Devices provides manufacturer documentation, registration status, tender support and supply coordination for BD peripheral vascular products. Detailed specifications and available configurations are available on request.
Sizes & Specifications
- Specifications
- Available on request
Manufacturer: C. R. Bard, Inc. (a BD company) · Reference source: bd.com
Product Features
Design characteristics as published by Bard.
Paclitaxel drug coating
BD states the balloon delivers a dose of 2 µg/mm² of paclitaxel to the vessel wall during angioplasty.
0.035″ configuration
The 035 device is the 0.035″ guidewire configuration within the Lutonix™ DCB family described by BD.
Femoropopliteal indication
BD indicates use for de novo, restenotic or in-stent restenotic lesions in the superficial femoral and popliteal arteries.
Robust size matrix
BD states the balloon offers a robust size matrix and extensive indications to treat lesions of varying sizes and lengths.
Level 1 clinical evidence
BD cites proven results in a Level 1 clinical trial for the platform.
Documentation
Official IFU, size matrix and full specifications are available on request through Azmed Devices.
Product Identification & Specifications
Reference identifiers for procurement, registration and tender documentation.
| Manufacturer | C. R. Bard, Inc. (a BD company) |
|---|---|
| Brand | Bard |
| Product Family | Peripheral Vascular |
| Country Availability | Azerbaijan |
Clinical Applications
The Lutonix™ 035 Drug Coated Balloon is a paclitaxel-coated pta balloon catheter (0.035″) in the Peripheral Vascular family from C. R. Bard, Inc. (a BD company), used by interventional specialists in procedures where a paclitaxel-coated pta balloon catheter (0.035″) of this class is indicated.
For the complete indications for use, contraindications and instructions for use (IFU), request the official Bard documentation through our clinical team. Azmed Devices supplies the Lutonix™ 035 Drug Coated Balloon to hospitals and clinics across Azerbaijan.
Downloads & Documentation
Instructions for use (IFU), technical datasheets and clinical literature for the Lutonix™ 035 Drug Coated Balloon are available on request from our clinical team.
Request DocumentationFrequently Asked Questions
- What drug and dose does the Lutonix balloon deliver?
- BD states the Lutonix™ drug coated balloon delivers a dose of 2 µg/mm² of paclitaxel to treat lesions in the superficial femoral and popliteal arteries.
- What does the 035 designation mean?
- BD offers the Lutonix™ DCB in 0.018 and 0.035 guidewire configurations; the 035 device is the 0.035″ guidewire configuration within that family.
- How can our hospital order Lutonix 035 Drug Coated Balloon in Azerbaijan?
- Contact Azmed Devices at info@azmeddevices.com. We provide manufacturer documentation, registration status and tender support, and coordinate supply for BD technologies.
