(Sahajanand Medical Technologies) PAINT trial results support safety and efficacy of the Infinnium a

FOR IMMEDIATE RELEASE
(Free-Press-Release.com) May 14, 2008 -- 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.”

The Infinnium ™- CE mark approved, stent system utilizes paclitaxel, which has been shown to reduce tissue proliferation in the coronary vessels following stent implantation.

drug eluting stent     Infinnium     Paclitaxel     Sahajanand     Sirolimus     Supralimus