News

First patient enrollment in MASCOT registry represents major milestone for COMBO™ Dual Therapy Stent and OrbusNeich’s clinical program.

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COMBO Dual Therapy Stent: A Long term Solution to Vessel Restoration. Latest results further support excellent healing benefits of World’s first and only Dual Therapy Stent.

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Combo



The first DES that actually heals*


The COMBO Dual Therapy Stent accelerates endothelial coverage and controls neo-intimal proliferation, providing a safe, no compromise solution for you and your patient.



* Virmani R: Pro-healing approach effectively promotes endothelialisation and reduces thrombogenicity,
Cardiovascular News International, May 2012


What's Different?
The only stent with a dual therapy approach





Why be satisfied with this …


OCT images of a monotherapy DES at 9 months with heterogeneous coverage


when you can have this


OCT images of COMBO Dual Therapy Stent at 9 months showing homogeneous coverage










Addressing Unmet Needs with Contemporary PCI

Improve efficacy profile – stable outcomes over time

  • Limit neo-intimal proliferation – Sirolimus elution

  • No chronic inflammation – Completely biodegradable polymer

  • Vessel healing – Abluminal drug elution & EPC capture

Improve safety profile – address late stent thrombosis

  • Rapid endothelial coverage and function – EPC capture

Reduce dependency on DAPT – vessel healing

  • Avoids risk associated with DAPT discontinuation

  • Lowers bleeding risk and its complications


PUBLISHED CLINICAL DATA

REMEDEE

  • Ongoing first-in-man, prospective, randomized, multi-center study at sites in Asia, Australia, Europe and South America that enrolled 183 patients with symptomatic, ischemic heart disease due to a stenotic lesion located in a native coronary artery; twelve-month results published in the April 2013 edition of JACC: Cardiovascular Interventions

  • Data showed that the COMBO Dual Therapy Stent was effective for the sustained control of neointimal proliferation; at nine-month angiographic follow-up, the in-stent late lumen loss for the COMBO Stent was 0.39 +/- 0.45 mm compared to 0.44 +/- 0.56 mm for the control drug eluting stent; this is well below the threshold of 0.50 mm shown in the literature to be effective in preventing repeat revascularization

  • The COMBO Dual Therapy Stent was shown to be safe, with an overall low rate of clinical events, a low rate of binary restenosis and no stent thrombosis observed up to 12 months; the major adverse cardiac event (MACE) rate at 12 months was 8.9% for the COMBO Stent group and 10.2% for the drug eluting stent group; the clinically driven target lesion revascularization (TLR) rate was 4.9% for the COMBO Stent group versus 8.5% for the drug eluting stent group
Product Specifications
 Stent
 Strut dimensions:  0.0035" (0.09 mm) x 0.0040" (0.10 mm)
 Radiopacity:  Moderate
 Material:  316L stainless steel
 Side branch access:  4.50 mm
 Foreshortening:  < 1 %*
 Recoil:  < 5 %*
 Vessel wall coverage:  17 %*
 Radial force (to 50% lumen collapse):  25 Psi*

 Balloon Catheter
 
 Proximal shaft:  Hypotube
 Nominal pressure:
 9 atm
 Rated burst pressure:  16 atm
 Avg. burst pressure:  > 28 atm
 Nominal crossing profile:  0.042" (1.06 mm)*
 Catheter tip length:  4.00 mm
 Max. guidewire OD:  0.014"
 Shaft (prox/distal):  2.3 F/2.9 F
 Guiding catheter compatibility:  5 F (0.057" ID min) 2.5-3.5 mm
 6 F (0.068" ID min) 4.0 mm
*3.0 mm diameter stent


Technical Drawing (Click on the picture to enlarge)