Polymer-Free Sirolimus Eluting Stent
Future Beyond Polymers
Polymers (Durable or Biocompatible) are an integral part of Drug Release Matrix in current generation DES as they ensure the Release Kinetics of the active drug, the critical determinant of antirestenotic efficacy. However, the mechanical properties of the Metallic Cage and Aggressive Inflammatory Reactions during polymer erosion are known to cause.
Current DES Polymers are often associated with Flaking, Webbing and Peeling which leads to impaired action of active drug.
VIVO ISAR is an innovative technology which eliminates the use of Polymer by using Dual Drug Technology: Sirolimus and Probucol
It is historically proven to impose anti-restenosis effects through anti-oxidative and direct anti-proliferative effects. Though in VIVO ISAR, it is not used as an Active Pharmaceutical Ingredient.
Probucol here mimics the role of a Polymer thus functioning as a drug carrier. Probucol is used as a Matrix-Builder for the controlled release of Sirolimus. Probucol binds the drug on the stent and its properties of being hydrophobic and anti-oxidative, facilitates a controlled and continuous drug release.
10 years follow up clinical data of safety and efficacy in 3002 patients is published in Journal of American College of Cardiology.
In the long-term analysis at 10 years (ISAR TEST 5 trial), Polymer-free VIVO ISAR showed numerically low rates of all-cause mortality, TVR, MI and Stent Thrombosis versus DP-ZES in the subset of diabetes mellitus.
World's Longest Studied Drug Eluting Stent
Even with no polymer, VIVO ISAR showed similar results with regards to safety and efficacy when compared with DES with permanent polymer in ACS patient subset
In this long term analysis at 10 years, Polymer Free Vivo ISAR in Diabetic patients showed numerically low rates of all-cause mortality, TVR MI, and stent thrombosis versus DP-ZES
In this long term analysis at 10 years , Polymer Free Vivo ISAR showed similar efficacy and safety
profile as PP-ZES
At 5 years, outcomes of patients treated with Vivo Isar compared with durable polymer-based ZES were similar in the subgroup of STEMI.
At 5 years in diabetic patient subset , outcomes of patients treated with Vivo Isar compared with PP-
ZES were similar
At 5 years, Vivo Isar with no polymer demonstrates similar rates of definite/probable stent
thrombosis as PP-ZES
At 2 years, Vivo Isar demonstrated 43% reduction in binary restenosis in comparison to PP-ZES and
23% reduction in comparison to PP-SES
In preclinical study , Vivo Isar demonstrated ideal drug release kinetics and better endothelialisation
as compared to polymer based and conventional polymer free stent.
A rough stent surface does not increase late lumen loss after stent implantation as compared with a conventional smooth stent surface.