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. However, there are certain risks associated with permanent polymers. Delayed arterial healing (DAH) following DES implantation has been demonstrated in human autopsy studies and animal models.
Risks Associated With Permanent Polymers*
- Persistent Fibrin Deposition
- Delayed Endothelialisation
- Chronic Inflammation
- Persistent Platelet Activation
- Prothrombogenic (potential to cause Stent thrombosis)
*Minerva Cardioangiologica 2009 October;57(5):567-84
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
Polymer Free Technology
Sirolimus
It is a well-studied and clinically proven Immunosuppressant.
It inhibits activation of T cells and B cells by reducing their sensitivity to interleukin-2 (IL-2) through mammalian target of rapamycin inhibition (mTOR).
Probucol: A Safer Alternative
- Probucol here mimics the role of a Polymer thus functioning as a drug carrier for the controlled release of Sirolimus.
- Probucol seems to be a much safer alternative to polymers for drug release resulting in better anti-restenotic efficacy for VIVO ISAR*
*Data on file (IMTR Report 20210931)
MICROPOROUS SURFACE
Micropores are created by Sandblasting Technique – A unique method used to enhance continuous drug delivery where pores are created to ensure optimum drug release kinetics which prevents Neointimal Proliferation leading to Restenosis and Stent Thrombosis.
PROBUCOL
Mimics the function of polymer by slowing down the release of Sirolimus drug.
SHELLAC RESIN (WAX FREE)
Prevents flaking and webbing of drug co-mix
SIROLIMUS
An anti-inflammatory and anti-proliferative agent.
ABLUMINAL COATING
Facilitates uni directional drug release and less systemic exposure, ensuring improved healing and faster Endothelialization.
Drug Release Kinetics
*Biomaterials 2009 Feb; 30(4):632-7
Clinical Studies
10 Year Follow up Data in Diabetic Patients*
Study Background
- DES with 10 years data of safety & efficacy in Diabetic patient subset.
Efficacy & Safety Outcomes
- Numerically low rates of All cause mortality.
- Notably low rates of Target vessel related myocardial infarction (33%).
- Significantly Iw rates of stent thrombosis (1.2%*).
10 Years Follow-up with 3002 Patients, Polymer-Free DES Showed Similar Results With
Regards To Safety & Efficacy When Compared WithDES With Permanent Polymer in
ACS Subset
At 10 years, the outcomes of patients treated with VIVO ISAR compared wiht durable polymer-based ZES were similar in the subgroup of Diabetic Patinets. Stuided in 3002 patients
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, Vivo Isar with no polymer demonstrates similar rates of definite probable stent thrombosis as PP-ZES
New-generation DES have been shown to improve both safety and efficacy outcomes as compared to early generation DES, including for patients with Coronary Artery Calcification At 10 years Clinical outcomes in patients with moderate-severe coronary calcification according to polymer coating strategies PF DES (n =755) TLR 26.1%, MI 6.5%, Definite or probable stent thrombosis 1.8% are lower as compared to Biodegradable Polymer or Permanent Polymer
In this long-term analysis at 10 years, polymer-free VIVO ISAR showed similar efficacy & safety profiles as durable polymer-based ZES. Studied in 3002 patients
At 5 years in diabetic patient subset , outcomes of patients treated with Vivo Isar compared with PP-
ZES were similar
