Opto Circuits receives DCGI license for sale of sirolimus drug eluting stent 'E-MAGIC Plus'
Opto Eurocor Healthcare Limited (OEHL), a subsidiary of Opto Circuits (India) Ltd., launched its first Sirolimus Drug Eluting Stent (DES), E-MAGIC Plus on receipt of Drug Controller General of India (DCGI) license to sell and market the product in India.
E-MAGIC Plus consists of a balloon-expandable intra coronary cobalt chromium stent pre-mounted on a custom balloon delivery system with a Sirolimus coating and a biodegradable polymer. The E-MAGIC Plus stent releases a distinctive anti-rejection drug, Sirolimus (also known as Rapamycin), into the arterial wall. Sirolimus helps control excess growth of cells and allows the artery to heal. E-MAGIC Plus stent has an extra edge with soft tip technology to provide smooth access to the lesion site ensuring minimal trauma to the vessel wall.
A stent is a wire metal mesh tube that is used to prop open an occluded artery during an angioplasty. Some stents are coated with a drug which is released into the wall of the artery to help minimize re-narrowing (restenosis) and the growth of scar tissues. The DES market has two major drug categories: Sirolimus and Paclitaxel. Stents coated with Sirolimus & its derivatives are rapidly gaining market share, thanks to the potent immunosuppressive nature of the drug and its comparative effectiveness in treating difficult lesions. In India, Sirolimus-based angioplasty devices have more than 90 per cent market share.
With the launch of E-MAGIC Plus, Opto Circuits becomes one of the few global players to offer DES products with a choice of two drug coatings.
“The Sirolimus DES market is estimated to be worth Rs. 800 crore in India”, said Vinod Ramnani, chairman & managing director, Opto Circuits (India) Ltd.
“E-MAGIC Plus has been developed indigenously in India and with the DCGI mark we can market and sell in India. The DCGI approval will also enable E-Magic Plus to be marketed in parts of Far East and parts of Middle East. We trust that E-MAGIC Plus will offer better treatment options and significant therapeutic advantages for the patients,” he added.
Opto Eurocor Healthcare Limited will launch E-MAGIC Plus in the European and Latin-American market after receiving the necessary approvals.