Banner US IN.PACT Admiral Drug Coated Balloon

Differentiated DCB Design Intended to Maximize Safety and Efficacy

Technology Highlights
 

PLATFORMDRUGEXCIPIENTCOATING PROCESS
MedtronicPaclitaxelUrea
 
Medtronic
• Admiral® PTA balloon
• 4 mm – 7 mm diameters
• 40, 60, 80, 120 mm lengths
• Hydrophobic, lipophilic
• Anti-proliferative drug
• Therapeutic, efficacious dose (3.5μg/mm2)
• Hydrophilic
• Naturally-occuring
• Non-toxic
• Uniform and stable
• Controlled and scalable

 

Mechanism of Action
 

IN.PACT Admiral Photo 1
1. IN.PACT Admiral is coated with a matrix of paclitaxel and an excipient urea.
 
IN.PACT Admiral Photo 2
2. The coating comes into contact with water in the bloodstream upon inflation, hydrating the urea, which facilitates the release of paclitaxel at the target lesion.
 
IN.PACT Admiral Photo 3
3. Paclitaxel penetrates the vessel wall, where it remains at a therapeutic dose for over 180 days, addressing the causes of restenosis.

Proprietary Balloon Coating Provides Efficacy while Maintaining Clinical Safety

  • Paclitaxel dose of 3.5 μg/mm2 for reduction of neointimal hyperplasia
  • Naturally occurring excipient urea enables rapid drug transfer

Paclitaxel Therapeutic Window


1. Scheller B et al. Paclitaxel Balloon Coating, a Novel Method for Prevention and Therapy of Restenosis. Circulation. 2004; 110:810-814
2. Speck U et al. Neointima inhibition: comparison of effectiveness of nonstent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology. 2006; 240:411-418
3. Cremers B et al. Comparison of two different paclitaxel-coated balloon catheters in the porcine coronary restenosis model. Clin Res Cardiol. 2009; 98:325-330
4. Cremers B et al. Drug-eluting balloon: Very short-term exposure and overlapping. Thromb Haemost. 2009; 101: 201-206
5. Rowinsky EK, Donehower RC. Paclitaxel (Taxol). N Engl J Med. 1995; 332:1004-1014
6. Margolis J et al. Systemic nanoparticle paclitaxel (nab-Paclitaxel) for in-stent restenosis I (SNAPIST-I): A first-in-human safety and dose-finding study. Clin Cardiol. 2007; 30:165-170

Exceptional Safety Profile at 12 Months

  • 95.7% primary safety composite, proving superior safety to standard PTA
  • Low, 1.4% and 3.8% thrombosis rates in IN.PACT SFA and IN.PACT Global, respectively
Defined as freedom from device- and procedure-related death at 30 days and freedom from target limb major amputation and CD-TVR at 12 months.

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