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Catheterization and Cardiovascular Interventions (CCI) Journal Publishes
Sahajanand Medical Technologies PAINT trial 1 year results |
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“The
74th issue of prestigious international journal
Catheterization and Cardiovascular Interventions published an article of
Sahajanand Medical Technologies PAINT
(PercutAneous
INTervention)
Trial - A randomized evaluation of two drug-eluting stents with
identical metallic platform and biodegradable polymer but different
agents (Paclitaxel or Sirolimus) compared against Bare stents: 1-year
result.” |
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Surat, India —October 30, 2009 – Sahajanand Medical
Technologies,
a leading developer
and manufacturer of Drug Eluting Stents, announced that the Journal of
the WILEY inter science - Catheterization and
Cardiovascular Interventions (CCI) has published 1 year results
from the PAINT trial (ClinicalTrails.gov ID:
NCT00752362). The article entitled “Randomized evaluation of two
drug-eluting stents with identical metallic platform and biodegradable
polymer but different agents (Paclitaxel or Sirolimus) compared against
Bare stents: 1-year results of the PAINT trial” is published
in the November
74th issue of CCI journal and available online at
http://www3.interscience.wiley.com/cgi-bin/fulltext/122445261/PDFSTART.
The CCI Journal is published by WILEY inter science to
focused on
material that will be of immediate practical value to physicians
providing patient care in the clinical laboratory setting. |
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The article, authored by Dr. Pedro A. Lemos,
MD, PhD at Dr. Eneas de Carvalho Aguiar, Sao Paulo Brazil, describes the
positive results from the 1-year follow-up of a multicenter, 274
patients (Sirolimus=106, Paclitaxel=111, Bare Metal Stent=57), Phase IV
study headed by Dr. Pedro A. Lemos himself. The Sirolimus drug-eluting
Stents, Paclitaxel drug eluting Stents and Bare metal Stents were
successfully implanted in a (2:2:1) randomization. |
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According to
Dr. Atul Abhyankar, Medical Director- Sahajanand Medical
Technologies,
“Both Paclitaxel and Sirolimus stents reduce the 9-month in-stent late
loss to 0.54±0.44 mm, 0.32±0.43 mm, vs. 0.90±0.45 mm for Bare metal
stent respectively, and 1-year risk of target vessel revascularization
and combined major adverse cardiac event is reduced for both DES in all
comparisons which proves the efficacy of Drug Eluting Stents against
Bare Metal Stents.” |
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The PAINT TRIAL nine months angiographic results analyzed by Cardialysis
(Rotterdam, Netherlands) showed that the
head-to-head comparison between two novel DES (Paclitaxel &
Sirolimus),
both the novel DES were effective in reducing neointimal hyperplasia,
late lumen loss, 1-year re-intervention and adverse cardiac event during
first year compared to Bare metal stent.
Sirolimus
Stents had lower late loss than Paclitaxel stents (less then 0.01) but
similar 1-year clinical outcomes. |
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Mr. J P Dutta, SMT’s Chief Operating Officer shared the significance by
citing “The article discusses about the result and conclusion of PAINT
trial which eventually reveal the benefit and safety of usage of
biodegradable polymer as a vehicle for DES irrespective of drugs.”
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“Results of PAINT trial reinforce the fact that our
proprietary blend of biodegradable polymers is
effective as a carrier for DES technology and also this proprietary
blend of polymers seems to work very effectively in both the
different kind of drugs,” said Mr. Rahul Gaywala, SMT’s Executive
Director. “It has been fundamental policy of SMT to promote evidence
based medicine and in the past many of the trials conducted have been
presented and published in index journals. The current publication too
is in keeping with the underlying fundamental principle. We are happy
that we have contributed positively to the interventional community.” |
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The Founder and Chairman of SMT Mr. Dhirajlal Kotadia said,
“Sahajanand Medical Technologies always stand in front to support this
and other large clinical trials that present the medical community with
important scientific data that can be used to provide optimal treatment
approach for complex patient subset.” |
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| About PAINT Trial:
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PAINT study was a unique 3-arm format
designed with following two objectives,
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1)
To test two novel drug-eluting stents (DES) covered with a
biodegradable-polymer carrier and releasing Paclitaxel or Sirolimus,
which were compared against a Bare metal stent. |
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| 2) DES differed by the drugs, but was identical otherwise, allowing
comparing the anti-restenosis effects of Sirolimus versus Paclitaxel.
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Angiographic follow-up was obtained at 9 months and major cardiac
adverse events up to 12 months.
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About CCI Journal:
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Catheterization
and Cardiovascular Interventions is an international journal and an
official publication of the society for cardiac angiography &
interventions. The journal focuses on material that will be of immediate
practical value to physicians providing patient care in the field of
interventional cardiology. Articles are subject to double-blind peer
review and complete editorial evaluation prior to any decision regarding
acceptability
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About Sahajanand Medical Technologies:
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Established in the year 1998, SMTPL became the
first Indigenous Stent Manufacturer in world to have two DES systems in
its product portfolio. SMTPL is the first company to get CE approval for
DES with Biodegradable Polymers. All the DESs are made with proprietary
blend of Biodegradable Polymers. The company has both Stainless Steel &
Cobalt Chromium platforms. It is India’s largest manufacturing company
based for Evidence Based Implantable Medical Devices and Medical
Equipments. The products are manufactured conforming to the
international quality standards and are offered at the most competitive
prices. The Company is ISO 9001 and ISO 13485 certified & also obtained
CE certification for its advanced range of products. This gives
assurance of company’s quality consciousness. For more information log
on to:
www.smtpl.com.
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