Patients with severe symptomatic aortic stenosis who suffer from comorbidities that make them poor candidates for open heart aortic valve surgery have an indication for a transcatheter aortic valve implantation (TAVI).
The JenaValve™ TAVI System is a catheter-based aortic valve implantation system which includes additional features compared to first generation, CE approved transapical TAVI systems. The 3-feeler element includes the ability to reposition the JenaValve™ during implantation procedure thus ensuring a correct and precise subcoronary, anatomical positioning within the native valve.
Further valve deployment is performed in a controlled 3-step mechanism which allows an implantation on the beating heart without cardiac arrest. In addition, the prosthesis is clipped onto the aortic valve of the patient by means of a "paper clip" mechanism. This prevents fluttering of the native aortic cusps in the outflow tract. Due to the use of a natural aortic porcine root bioprosthesis, a long time durable physiological valve function is expected with the JenaValve Prosthesis.
These features incorporated in the JenaValve™ TAVI System increase the safety of the valve implantation which may provide a direct benefit to the patient. With regard to the described product characteristics, the risk-to-benefit ratio is considered as favourable for the JenaValve TAVI system. Remaining risks are being considered to occur in the same ratio as for the existing competitive devices.
Patient benefits
Transcatheter aortic valve replacement is a new, minimally-invasive, treatment option that: