Dissolve™ Coronary Drug Coated Balloon

Product Description

The DKross™ PTCA Balloon Dilatation Catheter is a rapid-exchange (Rx) non-compliant coronary balloon catheter developed for percutaneous transluminal coronary angioplasty (PTCA).

Products Information

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

SpecificationDetails
Device TypeCoronary Drug Coated Balloon
Catheter TypeRapid Exchange (Rx)
Guidewire Compatibility0.014″
Balloon ComplianceNon-compliant
Balloon Diameters2.0 – 4.0 mm
Balloon Lengths10 – 35 mm
Catheter Length142 cm
Guiding Catheter Compatibility5F
Nominal Pressure10 atm
Rated Burst Pressure16 atm
Balloon MaterialNylon
Drug CoatingPaclitaxel
Drug Dose3.0 µg/mm²
ExcipientMidchain 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