Sahajanand Medical Technologies, India Receives CE mark on Two Sirolimus Eluting Coronary Stents

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June 26, 2011. Surat, India. Sahajanand Medical Technologies (SMT) announced today that it has received European CE marking for two Sirolimus eluting coronary stent systems; Supralimus® (Sirolimus eluting stents on stainless steel platform) & Supralimus-Core® (Sirolimus eluting stent on chromium cobalt platform).

The CE approval for Supralimus® and Supralimus-Core® brings the company the distinction of being the first in the world to have CE approval for both Sirolimus and Paclitaxel -eluting coronary stents and in total three CE approved drug eluting stents.

“The CE mark for Supralimus® and Supralimus-Core® is a significant accomplishment that substantiates our product’s excellent clinical outcomes. This further confirms our commitment to
providing patients and clinicians new treatment options for coronary artery disease.” shared Dhirajlal Kotadia-CEO of Sahajanand, “The excellent flexibility, highly deliverable system and proven safety and
efficacy of Sirolimus with the biodegradable polymers make our stents an excellent choice for a variety of patients” he added.

‘The drug coating in multiple layers with the use of biodegradable layers for the Supralimus and Supralimus Core stent is designed to deliver the drug in a biphasic manner: an initial burst dose,
followed by a controlled release of the drug which will likely reduce late adverse clinical events compared to stents with non-biodegradable polymer’ said Dr. Atul Abhyankar, Medical Director of
SMT and a renowned cardiologist. “In the early days of evolution of drug eluting stents SMT had the foresight about the safety of biodegradable polymers and was the first to pioneer the utilization of
biodegradable polymer on all of its type of drug –eluting stents " he added. Dr. Pedro Lemos MD, Ph.D, from InCor Institute, University of São Paulo Medical School shared his
own experience “I have been using the Supralimus stent for more than 5 years now, with an accumulated clinical experience that sums hundreds of patients. In addition, we have run a randomized trial that evaluated the short and long-term outcomes of patients treated with that stent. Both in daily practice as well as in the context of a clinical study, the Supralimus presented a very good clinical performance”.
SMT offers Stainless Steel and Cobalt Chromium bare metal stents, Paclitaxel eluting Stainless Steel stent and Sirolimus eluting Stainless Steel and Cobalt Chromium stents. The wide range of sizes of both Supralimus® and Supralimus–Core® from 8 mm to 40 mm with one of lowest strut thickness of CE approved chromium-cobalt and stainless steel stents.

Indications (Supralimus)

Supralimus® Sirolimus eluting coronary stent system is indicated for use in-patients with symptomatic ischemic heart disease due to coronary artery lesions with a reference vessel diameter ranging
from 2.25 mm to 4.00 mm and is intended to improve coronary luminal diameter.

Indications (Supralimus-Core)

Supralimus-Core™ Sirolimus eluting coronary stent system is indicated for use in-patients with symptomatic ischemic heart
disease due to coronary artery lesions with a reference vessel diameter ranging from 2.5 mm to 3.5 mm and is intended to improve coronary luminal diameter.