Sahajanand Medical Technologies PAINT Trial Results Support Safety and Efficacy of...
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Sahajanand Medical Technologies PAINT Trial Results Support Safety and
Efficacy of the Infinnium and Supralimus Stents
Sahajanand Medical Technologies received positive results of nine month PAINT
trials for Drug eluting stents, Infinnium and Supralimus. The results unveiled
during plenary session of EuroPCR 2008-Barcelona.
SURAT, India, May 20 /PRNewswire/ -- Sahajanand Medical Technologies Pvt.
Ltd. (SMT), Surat, India, leading developer and manufacturer of drug-eluting
stents, welcomed the positive results of the prospective, randomized nine
months results of PAINT trial (PercutAneous INTervention with biodegradable-
polymer based paclitaxel-eluting, sirolimus-eluting, or bare stents for the
treatment of de novo coronary lesions).
The PAINT study was designed with a unique 3-arm format that allows the
evaluation of three stents that only differ on the presence and/or type of
drug (all stents have exactly the same material, strut thickness and platform
design). This distinguishes the study from other comparative trials that
aimed to assess the differences between Sirolimus and Paclitaxel (having
different polymers and different platform).
The study hypothesizes that two novel formulations of stents with
Paclitaxel (Infinnium) or Sirolimus (Supralimus), eluted in biodegradable
polymers, are effective in reducing neointimal proliferation in comparison
with bare metal stents.
The nine month results of PAINT, which were unveiled on Tuesday May 13th
during the plenary session of EuroPCR 2008 -- Barcelona, Spain, demonstrated
that in comparison with bare metal stents, both formulations of
biodegradable-polymer Paclitaxel-eluting ( Infinnium ) and Sirolimus -eluting
(Supralimus) stents are effective in reducing neointimal proliferation and the
risk of repeat intervention at 270 days, without increasing the incidence of
death or myocardial infarction.
Primary investigator, Dr Pedro Lemos of the Heart Institute (InCor)
University of Sao Paulo Medical School, Brazil, commented that, "The design of
PAINT (2:2:1 randomization of 280 patient with coronary de novo lesions)
allowed to verify, in a single trial, the safety and efficacy of the two novel
drug-eluting stent formulations." He added that "Another important point is
that most previous comparative trials between Sirolimus & Paclitaxel used
stents with two different platforms and polymers." "In the PAINT -- which
used the same metal platform and coating for both active stents -- the effects
of Sirolimus and Paclitaxel could be compared in a more direct way, since the
only difference between the stents was the drug itself," he explains.
Dr Atul Abhyankar, Medical Director- Sahajanand's Medical Technologies,
shared the enthusiasm. "The results of the PAINT trial truly add to the
interventional community learning about DESs, it clearly proves that the
biodegradable polymer used by SMT is effective and safe vehicle for DES and
seems to work efficiently irrespective of the type of drugs. Both drugs
(Paclitaxel & Sirolimus) were effective in reducing restenosis on the same
vehicle and platform. So you have a luxury of choice of drug based on your own
assessment."
Mr. Dhirajlal Kotadia, the Founder and Chairman of SMT; emphasized the
company's commitment towards further intensifying its clinical research
initiatives and continue to deliver evidence-based treatments to all deserving
patients around the world.
The Infinnium - CE mark approved, stent system utilizes paclitaxel, which
has been shown to reduce tissue proliferation in the coronary vessels
following stent implantation, and is based upon the easily deliverable,
thinnest strut (0.0032") Matrix coronary stent platform.
Sahajanand Medical Technologies is (http://www.smtpl.com/) a global
developer & manufacturers of minimally invasive coronary stents, with one of
the broadest product portfolios in the industry.
(Infinnium , Infinicore, Supralimus , Supracore, Coronnium and Matrix).
Company Profile: Sahajanand Medical Technologies Pvt. Ltd.
Established in the year 1998, company became the first Indigenous Stent
Manufacturer in world to have two DES systems in its product portfolio. It is
India's largest manufacturing company based on 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 9000 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
This press release was issued through 24-7PressRelease.com. For further
information, visit http://www.24-7pressrelease.com.
SOURCE Sahajanand Medical Technologies Pvt. Ltd.
JP Dutta of Sahajanand Medical Technologies Pvt. Ltd., 91-261-245-1451,
pr@sahmed.com
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