New Percutaneous Transseptal Access Catheter Gets CE Mark


April 22, 2008

April 22, 2008 - Onset Medical received CE Mark Clearance to begin marketing its SoloPath transseptal access catheter in the European Union and select countries worldwide, offering a devie to allow percutaneous access to the chambers of the left heart and surrounding vasculature.

SoloPath reportedly offers interventional cardiologists and electrophysiologists a novel percutaneous approach to access the left atrium and pulmonary veins through the atrial septum for the diagnosis and treatment of conditions such as atrial fibrillation. Atrial arrhythmias, such as atrial fibrillation and flutter, affect more than 2.2 million people in the U.S. Many analysts project this to be the next major market in the treatment of cardiovascular disease.

The SoloPath is designed to allow for the insertion of a small catheter that when positioned in the atrium of the heart can be gently expanded to provide a large working lumen to perform therapeutic procedures. The resulting lumen is large enough to provide access of multiple diagnostic and therapeutic catheters and instruments.

CDT allows introduction of a dimensionally small catheter to a specific site, which once positioned, can be radially expanded to deploy a semi-rigid sheath to maintain access to the treatment site. The catheter enters the body at a diameter approximately 50 percent of the size of conventional access devices. Once placed in the body, the device is expanded in a slow and gentle manner, using radial force to create an internal diameter larger than conventional devices. Studies have shown that the CDT can allow the physician to achieve access quicker, easier and with less trauma to the surrounding tissue than with conventional access procedures.

For more information: