The Endothelizerâ„¢ EN-2212 receives CE Mark approval for laboratory use
on 14 / 07 / 2013

Vascuzell has successfully secured CE Mark approval for its CE markunique cell seeding platform, the EndothelizerEN-2212. The device is designed to coat the inner surface of vascular grafts and patches with vascular cells to improve the biocompatibility and in-vivo performance of these implants. The CE Mark approval was received following a review of the safety compliance by a third-party notified laboratory.



Héctor Perea, Founder and CEO of Vascuzell, said:

“The Endothelizer™ represents a decisive leap forward towards the realization of a new generation of vascular grafts with enhanced biocompatibility, larger durability and a broader scope of application. We pursue to overcome the performance gap currently existing between synthetic grafts and natural blood vessels. The Endothelizer™ enables the transformation of the synthetic inner surface of vascular grafts into a functional surface with anti-thrombogenic properties, thus mimicking the performance of the native endothelium.”

María Ruiz, co-founder and Head of Market Development of Vascuzell, mentioned:

“The achievement of the CE Mark for our Endothelizer™ is a significant milestone that will allow us to accelerate the clinical validation of our technology. We have focused on developing a technology that addresses the limitations of today´s implants and enables a rapid translation to the clinical practice. Among its multiple applications, we have looked for niches with higher unmet needs, such as peripheral vascular grafting below-knee, hemodialysis and congenital among others.”

Juanjo Garcés, co-founder and Chief Technical Officer at Vascuzell stated:

“We have designed a user-friendly and flexible platform that addresses the main needs of lab specialists and cardiovascular surgeons. The seeding equipment can be configured to coat a wide range of materials, diameters and lengths — always guaranteeing a homogenous and efficient seeding process.”