Siemens Healthineers receives CE mark for the ACUSON AcuNav Volume ICE catheter

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Siemens Healthineers has announced that it has received CE Mark for the AcuNav Volume ICE (intracardiac echocardiography) catheter, an imaging guide that provides real-time, wide-angle visualisation of heart anatomy during structural heart and electrophysiology procedures.

“The AcuNav Volume ICE catheter is a pioneering innovation in structural heart disease. It is a result of Siemens Healthineers’ focus on designing catheters that meet the needs of interventional cardiologists and electrophysiologists for clinical efficiency with reduced scheduling efforts, staffing needs, procedure time and costs,” said Jim Gilmore, head of intracardiac imaging, Siemens Healthineers.

The AcuNav Volume ICE catheter enables treatment of patients who were not able to previously receive access to structural heart procedures, including patients with TOE (transoesophageal echo) or general anaesthesia contraindications, as well as some patients suffering from tricuspid regurgitation.

The tricuspid valve can be sufficiently visualised with TOE imaging in only 11% of cases. Less than 0.5% of 1.6 Million of patients with moderate or severe tricuspid regurgitation are treated annually.

“Today, we see an increasing focus on the so called “forgotten valve”—the tricuspid valve. Due to the increasing number of repair and replacement devices for the tricuspid valve, imaging guidance for these procedures is getting more important than ever. With the AcuNav Volume ICE catheter, we are able to clearly visualize the tricuspid valve anatomy from the right heart atrium”, said Ralph von Bardeleben, head of the Center of Structural Heart Disease Interventions and the Heart Valve Center, Mainz, Germany.

“The interest in using 4D Volume ICE came through a patient need”, said Carlos Sanchez, Ohio Health Riverside Methodist Hospital, Columbus, USA. ”For patients not able to undergo TOE or general anaesthesia, we started using 4D ICE for LAAC (left atrial appendage closure). With 4D Volume ICE you only need one view, and from that view you can reconstruct the whole LAA. Once the device is deployed, you can do all the required measurements to comply with the PASS criteria, which is very important to make this procedure successful.”

The AcuNav Volume ICE catheter is offered on the ACUSON SC2000 PRIME ultrasound system.


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