The next generation technology in coronary stenting has arrived in form of BioResorbable Vascular Scaffolds (BRS). The concept of cameo appearance (implantation) of a stent for acute benefits and its eventual disappearance in order to free the vessel of a metal cage is not just enticing; it appears to be the ultimate goal in achieving biomimicry in coronary stenting. However, the research on bioresorbable scaffolds (BRS) has been long drawn over the past two decades. Technological barriers and limitations into our insight regarding biomaterial science have further slowed down the progress. While several technologies in BRS are under development, the initial results driven by 1st generation technologies are encouraging and path breaking.

Low long term MACE, lumen enlargement, restoration of vasomotion in scaffolded segment are some of the currently understood benefits of BRS technology. Several platforms currently use the primary scaffold backbone as poly-L-lactide (PLLA) which insitu undergoes hydrolysis resulting in a mass loss and further cleavage of the long chains into easily metabolized lactic acid. The resultant conversion to CO2 and H2O via Kreb’s cycle is now well catalogued. The process is completed in a range of 24 - 36 months. An anti-proliferative coating optimally ensures minimization of restenosis.

Amongst several BRS’ under development worldwide, MeRes100 – Sirolimus Eluting BioResorbable Vascular Scaffold System is fully developed by Meril R&D in India and is a next generation BRS. The device is a clever iteration with a low profile delivery system; desirably thinner struts (100µm) and is easier to deploy since it has 3 radiopaque markers at each end, which facilitate ease of procedure.

MeRes100 comprises of the following components:-

  • A balloon expandable BRS made from polymer – poly-L-lactide (PLLA)

  • A top-coat comprising of an anti proliferative agent – Sirolimus (1.25 μg/mm2) eluting from PDLLA, a biodegradable formulation

  • A rapid exchange PTCA balloon catheter which acts as the scaffold delivery system

Pre-Clinical Proof of Concept

MeRes100 has been extensively studied in established pre-clinical study models in order to substantiate the acute operational performance of the device and to further consolidate its acute, intermediate and long term biomechanics, biocompatibility and pharmacokinetics (pK). The studies have been undertaken using porcine model with control arms such as to predicate BRS and metal based DES approved for commercial use.

MeRes100 BRS demonstrated satisfactory acute operational performance, as well as adequate behavior in terms of chronic biomechanics, favorable patency and neointimal growth when compared to benchmark predicate BRS and metal DES*.

Regulatory Update & MeRes-1 FiM Clinical Trial

Currently this novel technology is being studied in human clinical trials in India and globally. MeRes-1 ( - CTRI/2015/04/005706) is a prospective, multicenter, single arm, open label, pilot clinical study of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in the treatment of de-novo native coronary artery lesions. The study is enrolling patients (N=108) across 16 prominent centers in India.

The primary safety end point will be ischemia driven major adverse cardiac event (ID MACE) at 6 months. Clinical endpoints include ischemia driven MACE, ischemia driven TVF, TLR, TVR, scaffold thrombosis at 30 days, 6 months and at 1, 2, 3 years. Additionally acute device and procedural success will be determined.

As on date several cases have been completed with good acute and short-term results.

Baseline Angiography*

Post Procedure*

MeRes100 3.00x19mm OCT 3D reconstruction images*

Dawn of New Technology Era

The MeRes100 BRS technology represents an emerging BRS concept resulting in biomechanical properties comparable to other BRS and moving towards conventional metal DES - low strut thickness, high radial force, radiopacity, high retention forces, biomechanical stability and stable molecular weight loss at long term.

Animal studies confirmed the absence of thrombogenicity of the material and stability of the biomechanical properties. MeRes-1 the FiM has begun enrollment and will soon confirm the usefulness of this promising device in clinical situations.

*Data on file at Meril Life Sciences.
MeRes100 is an investigational device and under clinical study. Not available for commercial sale.