05.05.15
Eurocor GmbH, a group company of Opto Circuits (India) Ltd., has received CE Mark approval for its E-Magic Plus Sirolimus Eluting Coronary Stent System.
The E-Magic Plus system combines the ultra-thin strut of a cobalt chrome stent with an optimal Sirolimus coating. A fully biodegradable polymer minimizes delayed healing and late adverse events, according to the company.
“The CE mark approval of E-Magic Plus, represents a key milestone for Eurocor GmbH. We are now back in the largest cardiovascular product range, the drug-eluting stent. Thanks to its technology, we’ll be able to further expand treatment options for patients with introduction of E-Magic Plus™ – a highly differentiated DES with Sirolimus Coating and biodegradable polymer,” said Vinod Ramnani, co-founder, chairman and managing director of Opto Circuits.
E-Magic Plus received registration approval in India last year and has been available for sale for few months. More than 3,000 implants have been completed so far, and preliminary outcomes are in line with expectations, with no MACE (death, non-fatal myocardial infarction or any re-intervention).
“E-Magic Plus has the lowest strut thickness, which is key to reduce risks of clinical and angiographic restenosis. I’m very happy with its acute results as well as post therapy results,” added professor P. Chandra of The Medicity in Gurgaon, India.
With this CE Mark approval, Eurocor GmbH is preparing to make the E-Magic Plus commercially available in Europe and other markets where CE Mark approval can expedite the registration process.
Eurocor is a European Life Sciences Technology Corporation specializing in the research, development and manufacture of cardiovascular and endovascular products. Bonn, Germany-based Eurocor provides interventional physicians with innovative coronary stent technologies and special cardiovascular and endovascular devices, manufactured in Europe. Products are indicated for minimally cardiovascular and peripheral surgery and comply with biological and biomechanical principles to offer highly flexible, adaptable solutions.
The E-Magic Plus system combines the ultra-thin strut of a cobalt chrome stent with an optimal Sirolimus coating. A fully biodegradable polymer minimizes delayed healing and late adverse events, according to the company.
“The CE mark approval of E-Magic Plus, represents a key milestone for Eurocor GmbH. We are now back in the largest cardiovascular product range, the drug-eluting stent. Thanks to its technology, we’ll be able to further expand treatment options for patients with introduction of E-Magic Plus™ – a highly differentiated DES with Sirolimus Coating and biodegradable polymer,” said Vinod Ramnani, co-founder, chairman and managing director of Opto Circuits.
E-Magic Plus received registration approval in India last year and has been available for sale for few months. More than 3,000 implants have been completed so far, and preliminary outcomes are in line with expectations, with no MACE (death, non-fatal myocardial infarction or any re-intervention).
“E-Magic Plus has the lowest strut thickness, which is key to reduce risks of clinical and angiographic restenosis. I’m very happy with its acute results as well as post therapy results,” added professor P. Chandra of The Medicity in Gurgaon, India.
With this CE Mark approval, Eurocor GmbH is preparing to make the E-Magic Plus commercially available in Europe and other markets where CE Mark approval can expedite the registration process.
Eurocor is a European Life Sciences Technology Corporation specializing in the research, development and manufacture of cardiovascular and endovascular products. Bonn, Germany-based Eurocor provides interventional physicians with innovative coronary stent technologies and special cardiovascular and endovascular devices, manufactured in Europe. Products are indicated for minimally cardiovascular and peripheral surgery and comply with biological and biomechanical principles to offer highly flexible, adaptable solutions.