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CeraFlex™ Multi-Fenestrated ASD Occluder

12 March 2018

Product Features

Innovative delivery system

360° flexible rotation, accurate positioning.

Pre-mounted delivery system, convenient operation.

lock/release mechanism, safe placement and detachment.

M.A. Astarcioglu, etc., Ceraflex versus Amplatzer occluder for secundum atrial septal defect closure, Multicenter clinical experience, Herz. 2015 Apr;40(Supplement 2):146-150. Epub 2015 Feb 8.

Titanium Nitride coating technology

Prevent Nickel leaching.

Accelerate endothelialization and close defect rapidly. 

Soften Nitinol material and provide a more compliant and flexible implant.

Excellent braided structure

Offer potential benefits to decrease the chance of clot formation on the left atrial disc with braided technology instead of distal clamp.

Offer better adaptation in the interatrial septum with flexible disc.

Strategic Membrane Selection 

PTFE membrane was sewn into PDA devices to decrease residual shunt.

PET membrane was sewn into the ASD/PFO devices to get lower profile sheath.

Product Specification

 

CeraFlexTM Multi-Fenestrated ASD Occluder

Code   Right Disc Diameter
(mm)
  Left Disc Diameter
(mm)
Waist Length (mm) Minimum Recommended Sheath Size SteerEaseTM (Fr.)
LT-ASDf-MF-1818 18 18 3 SFA9F-f
LT-ASDf-MF-2518 25 18 3 SFA10F-f
LT-ASDf-MF-2525 25 25 3 SFA10F-f
LT-ASDf-MF-3030 30 30 3 SFA12F-f
LT-ASDf-MF-3525 35 25 3 SFA14F-f
LT-ASDf-MF-3535 35 35 3 SFA14F-f
LT-ASDf-MF-4040 40 40 3 SFA14F-f

Evidence Based Medicine

Ceraflex versus Amplatzer occluder for secundum atrial septal defect closure: Multicenter clinical experience 

M.A. Astarcioglu, etc., Herz 2015, DOI 10.1007/s00059-014-4192-0

© Urban & Vogel 2015

Between 2010 and 2014, 125 patients underwent atrial septal defect closure with the CeraFlexTM septal occluder (n = 58) and the Amplatzerseptal occluder (n = 67) under transesophageal echocardiography guidance. Patient characteristics, the stretched size of the defect, device size, and fluoroscopy time were similar between the groups. The immediate and follow-up complete occlusion rates for both groups were 100%. There was no device embolization, procedure-related stroke, or pericardial effusion.

From the study, the CeraFlexTM septal occluder is a safe and efficient device for closure of secundum atrial septal defects with no procedural complications. The CeraFlexTM has similar outcomes when compared with the Amplatzer septal occluder device. The advantage of the CeraFlexTM  septaloccluder device is that it can be deployed without the tension of the delivery catheter.

 

 

 

 

Jordan's unique, strategic location in the heart of the Middle East, as well as being at part of the African, European and Asian Production and consumption markets, makes it a link between the three continents. Throughout the years Jordan was able to provide a base of political and economic stability. Therefore, Jordan has been for many years a focal trading center in the Middle East, open to foreign investment, with one of the youngest, most highly educated population in the region. Today, Jordan has proved its ability to grow and is now well positioned to reap the rewards of any improvements in the political and economic integration of the region. On the same hand, Jordan is the ideal base for businesses interested in investing in the Middle East and North Africa region, Offering unparalleled opportunities for companies establishing a regional base in a country with numerous opportunities for doing business, especially after the economic and legal reform it went through,Currently, Jordan is performing major reforms in the healthcare sector. Hospitals and medical centers are being renovated; investments are made in Hi-Tec medical equipment, along with settlement of mutual relationship Jordan's Ministry of Health seeking with coequals in further countries. JGS is situated in Amman, the capital. In addition, JGS has established a regional office in the free zone which gives a hand facilitating the transfer of products between countries.