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PTCA Balloon | Drug-Coated Balloon
Sirolimus-coated PTCA balloon catheter that delivers the drug into the artery wall during angioplasty, without leaving a stent behind. Drug particles of different sizes in a matrix coating help the drug reach each layer of the vessel wall.
| Product type | Sirolimus-coated PTCA dilatation catheter (drug-coated balloon) |
| Balloon material | Nylon |
| Drug | Sirolimus |
| Drug loading | 2.75 µg/mm² |
| Balloon type | Semi-compliant |
| Balloon diameters | 1.50, 2.00, 2.50, 3.00, 3.50, 4.00 mm |
| Balloon lengths | 6, 10, 12, 15, 20, 25, 30, 35, 40 mm |
| Catheter length | 142 ± 2 cm |
| Rapid exchange length | 25 ± 1 cm |
| Tip entry profile | 0.45 ± 0.02 mm |
| Crossing profile | 0.60 mm minimum, 0.84 mm maximum |
| Proximal shaft outer diameter | 1.97 F (0.653–0.660 mm) |
| Distal shaft outer diameter | 2.56 F (0.83–0.87 mm) |
| Proximal shaft inner diameter | 0.480 ± 0.01 mm |
| Nominal pressure | 6 atm |
| Rated burst pressure | 14 atm |
| Average burst pressure | Not less than 18 atm |
| Minimum guiding catheter | 5 F (0.056 inch) |
| Maximum guidewire | 0.014 inch (0.36 mm) |
| Inflation time | Not more than 10 seconds |
| Deflation time | Under 20 seconds on average |
| Certification | ISO 13485:2016, CE (notified body 1035) |
Mamba comes in 6 diameters and 9 lengths. Order codes follow the pattern MD + diameter + length (for example, MD30020 is 3.00 mm × 20 mm).
| Length | 1.50 mm | 2.00 mm | 2.50 mm | 3.00 mm | 3.50 mm | 4.00 mm |
|---|---|---|---|---|---|---|
| 6 mm | MD15006 | MD20006 | MD25006 | MD30006 | MD35006 | MD40006 |
| 10 mm | MD15010 | MD20010 | MD25010 | MD30010 | MD35010 | MD40010 |
| 12 mm | MD15012 | MD20012 | MD25012 | MD30012 | MD35012 | MD40012 |
| 15 mm | MD15015 | MD20015 | MD25015 | MD30015 | MD35015 | MD40015 |
| 20 mm | MD15020 | MD20020 | MD25020 | MD30020 | MD35020 | MD40020 |
| 25 mm | MD15025 | MD20025 | MD25025 | MD30025 | MD35025 | MD40025 |
| 30 mm | MD15030 | MD20030 | MD25030 | MD30030 | MD35030 | MD40030 |
| 35 mm | — | MD20035 | MD25035 | MD30035 | MD35035 | — |
| 40 mm | — | MD20040 | MD25040 | MD30040 | MD35040 | — |
— Not available.
Balloon diameter (mm) at each inflation pressure. Green is the nominal pressure (6 atm); red is the rated burst pressure (14 atm). Do not inflate beyond the rated burst pressure.
| Pressure (atm) | 1.50 mm | 2.00 mm | 2.50 mm | 3.00 mm | 3.50 mm | 4.00 mm |
|---|---|---|---|---|---|---|
| 2 | 1.28 | 1.77 | 2.23 | 2.65 | 3.1 | 3.5 |
| 4 | 1.4 | 1.9 | 2.39 | 2.86 | 3.31 | 3.82 |
| 6 (nominal) | 1.5 | 2 | 2.5 | 3 | 3.5 | 4 |
| 8 | 1.58 | 2.07 | 2.57 | 3.11 | 3.65 | 4.13 |
| 10 | 1.64 | 2.14 | 2.63 | 3.18 | 3.76 | 4.23 |
| 12 | 1.69 | 2.22 | 2.68 | 3.24 | 3.84 | 4.31 |
| 14 (rated burst) | 1.73 | 2.29 | 2.73 | 3.31 | 3.9 | 4.38 |
| 16 | 1.79 | 2.39 | 2.78 | 3.37 | 3.96 | 4.44 |
| 18 | 1.86 | 2.5 | 2.82 | 3.44 | 4.04 | 4.48 |
| 20 | 1.94 | 2.64 | 2.86 | 3.52 | 4.14 | 4.52 |
In a drug-coated balloon procedure, the narrowed artery is usually prepared first with a plain angioplasty balloon. The cardiologist then passes the drug-coated balloon to the same spot over a guidewire and inflates it with an inflation device. While the balloon presses against the wall, the drug moves into the tissue. The balloon is then deflated and removed, so no metal is left in the artery.
Mamba carries sirolimus, the same family of drug used on the MedSure and Sirova stents. The choice between a drug-coated balloon and a stent is a clinical decision for the treating cardiologist.
Pulse supplies the main single-use items for a cath lab, so one supplier answers for supply and documents.
| Pulse product | What it does |
|---|---|
| AcuSafe Micro-Access Introducer Kits | Small-needle first puncture of the artery or vein, then a sheath |
| AcuSafe Introducer Kits | Sheath and dilator that keep the vessel open for catheters and wires |
| GuideX Guidewires | Wires that guide sheaths and catheters into place and support exchanges |
| Optima Manifolds | Control contrast injection, flushing and pressure monitoring |
| Glider PTCA balloons (SC, NC, CTO) | Open the narrowed artery before a stent, and expand the stent fully after |
| Optima Inflation Device Kit | Inflates the balloon to a measured pressure to open the artery and expand the stent |
| Evera, Sirova, EvroSure and MedSure stents | Drug-eluting stents that hold the opened artery open |
| Mamba drug-coated balloon (this page) | Delivers sirolimus to the artery wall without leaving a stent behind |
| AcuSafe Blunt Needle | Controlled access for percutaneous drainage (interventional radiology) |
Share the sizes you use and your monthly volume, and request a quote. Ask for the brochure, IFU and certificates with your quote.
Complete the setup
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Got Questions?
A drug-coated balloon (DCB) is an angioplasty balloon coated with a drug. When it is inflated in a narrowed artery, the drug passes into the artery wall to help stop it narrowing again. Unlike a stent, nothing is left behind once the balloon is removed.
Mamba is coated with sirolimus at 2.75 µg/mm², in a matrix coating with particles of different sizes so the drug can reach each layer of the vessel wall.
Diameters of 1.50, 2.00, 2.50, 3.00, 3.50 and 4.00 mm, and lengths of 6 to 40 mm. The 1.50 mm and 4.00 mm sizes go up to 30 mm long.
The nominal pressure is 6 atm, the rated burst pressure is 14 atm and the average burst pressure is not less than 18 atm.
Mamba is a rapid exchange catheter that works with a 5F (0.056 inch) or larger guiding catheter and a guidewire up to 0.014 inch.
The Mamba brochure lists ISO 13485:2016 and CE marking (notified body 1035). Ask the Pulse team for the current CDSCO licence and certificates.
Message Pulse on WhatsApp at +91 90711 01108 with your sizes and monthly volume, or download the brochure on this page for full specifications.