The SBIRI funding boosted the efforts of Relisys Medical Devices to
develop an improved version of drug-eluting stent that is helpful in
Hyderabad-based Relisys Medical Devices has developed an advanced
version of its drug-eluting stent (DES). The previous version was
designed to eliminate the drawbacks of the currently available
polymer-coated drug-eluting stent. DES is a coronary stent (a scaffold)
placed into narrowed, diseased coronary arteries that slowly releases a
drug to block cell proliferation. This prevents fibrosis that, together
with clots (thrombus), could otherwise block the stented artery, a
process called restenosis.
The government funding from the Small Business Innovation Research
Initiative (SBIRI) came as a boost to the research activities at
Relisys. Prior to the fund allocation, stents were manufactured on
contract basis in Europe and there was inconsistency in the quality.
The company achieved a new milestone when its new cardiac stent
manufacturing facility was inaugurated by the former President of
India, Dr APJ Abdul Kalam, in 2007, in Hyderabad. This stent is
indeed a highly-competitive product for a great societal mission.
Equipped with an in-house laser processing facility, Relisys
manufactures stents with consistent quality and better mechanical
properties. This resulted in better coating quality and predictable
drug release kinetics. With the better quality control equipments like
SEM/ measurement microscopes, the ramp up time from R&D to pilot
scale and pilot scale to production was minimized. This enabled the
company to launch the base stents quickly in the market.
The indigenous manufacturing of the product has provided better option
for the patients. Relisys' new DES consists of a Cobalt-Chromium (CoCr)
stent, coated with a porous carbon/carbon composite nano-structured
matrix containing the active drug. DES sold under the brand name,
COREL+C, is based on inorganic carbon coating where drug particles are
homogeneously distributed inside the matrix. The coating is designed to
maximum elasticity and its hardness exceeds stainless steel in terms of
abrasion and scratch resistance, eliminating flaking, de-lamination or
particle release. The advantages of DES are its low inflammation score,
low fibrins score, 100 percent drug release, enhanced
endothelialization, CoCr platform for better trackability and
crossability and high radial strength.
With the success of this PPP initiative, an advanced DES is now
available in the market at an affordable price. The company will price
this product at around $1,200 (
55,000), which is 50 percent lesser
than the market price of DES. The overall reduction in foreign exchange
outflow would be around $11 million (
50 crore) during the life span of
the product. So far, the bare metal stent that was used as the base for
the DES has been commercialized. DES is expected to be commercialized
by the end of 2011.
in New Delhi