Cera - Model PDA - Occluder

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.

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.