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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.
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May 13, 2008 (FPRC) -- 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”).
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 São 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
Send an email to JP Dutta of Sahajanand Medical Technologies Pvt. Ltd.
+91-261-245-1451
Keywords:
drug eluting stent, Paclitaxel, Sirolimus |
