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Pediatric Cardiology > Lifetech Scientific > Cera™ PDA Occluder

Cera™ PDA Occluder





Nitinol wire frame coated with Titanium Nitride (TiN)

Decrease the dissolution of nickel ion efficiently, expected safe long-term biocompatibility.

Promote the growth of endothelial tissue, lessen thrombus complication.

Superior superelastic, effectively reduce atrioventricular block occurrence.



Nickel ion concentration in whole blood                                  Nickel ion concentration in endocardium

D.Y. Zhang, W.J. Zeng, Z.J. Zi, and P.K. Chu, Fabrication of graded TiN coatings on nitinol occluders and effects on in vivo nickel release, Materials Science and Engineering C. 29 (2009), 1599-1603.


 



Cera Animal Study: Compared to Nitinol occluder, the Cera occluder have demonstrated that faster and better growth of endothelial cell and lower risk of thrombus formation. 


Strategic Membrane Selection

The ASD/PFO covered by a PET membrane that minimizes the chance of clot formation and has a small volume to get into lower profile sheath.

The VSD/PDA occluder covered with a PTFE membrane, which has a denser structure suited for high pressure defect.


Conform anatomical features of the defect, providing optimal design

3 types of peri-membranous VSD and a muscular VSD devices designed for different kind of VSD.

The ASD waist diameter available ranging from 6 to 42 mm, and the PDA occluder ranging from 0406 to 2224.



CeraTM PDA Occluder

Code

 Waist Diameter (mm)

 Proximal Diameter (mm)

Distal Diameter (mm)

Waist Length (mm)

Minimum Recommended Sheath Size SteerEaseTM (Fr.)

LT-PDA-0406

10

4

6

7

SFP6F

LT-PDA-0608

12

6

8

7

SFP7F

LT-PDA-0810

14

8

10

7

SFP7F

LT-PDA-1012

16

10

12

7

SFP8F

LT-PDA-1214

20

12

14

7

SFP9F

LT-PDA-1416

22

14

16

8

SFP9F

LT-PDA-1618

24

16

18

8

SFP10F

LT-PDA-1820

26

18

20

9

SFP12F

LT-PDA-2022

28

20

22

9

SFP12F

LT-PDA-2224

30

22

24

10

SFP14F



Cera™ Clinical study in China:

Principal Investigator: Zhang Zhiwei, MD, FACC, Guangdong Cardiac Institute.

Evaluation of efficacy and safety of Cera™ septal defect occluder for congenital cardiac detect: A multicenter, randomized and controlled clinical trial.

- 11 medical centers,460 cases enrolled (231 Cera™, 229 HeartR™).

- Follow up endpoint: 1, 3, 6, 12 months.

Study conclusion:

The success rate of immediate complete occlusion with Cera™ occluder is higher than 97.8%.

The results showed that the incidence of residual shunt were relatively less.

The arrhythmia incidence in Cera group is lower than that in HeartR group which as much as 36%.


Cera™ PM-VSD clinical study in Brazil:

Principal Investigator: Doctor Raul Arrieta and tutored by Doctor Carlos Pedra.

Prospective, multicenter, non randomized study.

Starting on November 2010.

3 Brazilian institutions, 56 patients.

Follow up endpoint: 1, 3, 6, 12 and 24 months.

Initial Result:

The percutaneous closure of peri-membranous ventricular septal defect with Cera™ Device has showed a safe effect with excellent immediate occlusion and low complication.