The Dissolve™ Coronary Drug Coated Balloon (DCB) is a rapid-exchange coronary angioplasty balloon catheter developed for drug delivery during percutaneous coronary intervention (PCI). The device combines mechanical vessel dilatation with localized antiproliferative drug transfer to help reduce restenosis while avoiding permanent metallic implantation.
Product Overview
Dissolve™ is coated with paclitaxel at 3.0 µg/mm² using a midchain triglyceride excipient system designed to facilitate rapid drug transfer into the vessel wall during balloon inflation. The system is indicated primarily for:
- Coronary in-stent restenosis (ISR)
- Small vessel coronary disease
- Selected de novo coronary lesions
The device is intended for vessels with diameters generally between 2.0 mm and 2.75 mm according to manufacturer indications.
Key Features
- Paclitaxel drug coating for antiproliferative therapy
- No permanent implant left behind
- Rapid Exchange (Rx) platform for easier procedural handling
- Non-compliant balloon design for controlled expansion
- 5F guide catheter compatibility
- Low crossing profile for improved deliverability in complex coronary anatomy
- Broad balloon size matrix for coronary intervention flexibility
Technical Specifications
| Specification | Details |
|---|---|
| Device Type | Coronary Drug Coated Balloon |
| Catheter Type | Rapid Exchange (Rx) |
| Guidewire Compatibility | 0.014″ |
| Balloon Compliance | Non-compliant |
| Balloon Diameters | 2.0 – 4.0 mm |
| Balloon Lengths | 10 – 35 mm |
| Catheter Length | 142 cm |
| Guiding Catheter Compatibility | 5F |
| Nominal Pressure | 10 atm |
| Rated Burst Pressure | 16 atm |
| Balloon Material | Nylon |
| Drug Coating | Paclitaxel |
| Drug Dose | 3.0 µg/mm² |
| Excipient | Midchain Triglyceride |
Available Configurations
Balloon Diameters
- 2.00 mm
- 2.25 mm
- 2.50 mm
- 2.75 mm
- 3.00 mm
- 3.25 mm
- 3.50 mm
- 4.00 mm
Balloon Lengths
- 10 mm
- 15 mm
- 20 mm
- 25 mm
- 30 mm
- 35 mm
Clinical Advantages of Drug Coated Balloon Technology
Drug-coated balloons are designed to deliver antiproliferative medication directly into the vessel wall during inflation while avoiding additional stent layers. Clinical literature notes several potential benefits:
- Reduced risk of multiple stent layers
- No permanent scaffold implantation
- Potentially shorter dual antiplatelet therapy (DAPT) duration
- Useful for ISR and small vessel disease
- Preservation of future treatment options
Mechanism of Action
During balloon inflation, paclitaxel coating contacts the arterial wall and transfers drug into vascular tissue. The antiproliferative effect helps inhibit neointimal hyperplasia, a key contributor to restenosis after PCI.
Clinical Evidence
The Dissolve SVD Randomized Trial evaluated the Dissolve DCB in coronary small vessel disease against drug-eluting stents (DES), highlighting growing clinical interest in DCB-based treatment strategies for small coronary vessels.
International consensus documents on coronary DCBs also recognize paclitaxel-coated balloons as an established option for ISR and selected coronary lesions.
Typical Applications
- Coronary in-stent restenosis (ISR)
- Small vessel coronary artery disease
- De novo coronary lesions
- PCI procedures where “leave nothing behind” strategies are preferred
- Patients where avoiding additional stent layers may be beneficial
Manufacturer
Manufactured by DK Medical Technology Co., Ltd.
Official product page:
Dissolve™ Coronary Drug Coated Balloon