News | March 17, 2007

Newly Cleared SoloPath Enables Percutaneous Transseptal Access

March 19, 2007 — Onset Medical Corp. has announced it has received FDA clearance to begin marketing the SoloPath transseptal access catheter in the U.S. SoloPath utilizes Onset's patented Controlled Deployment Technology (CDT) to allow percutaneous access to the chambers of the left heart and surrounding vasculature.

The company has developed several unique product platforms based on its CDT, which represents a new and different approach to procedures requiring minimally invasive access to remote sites within the body. CDT allows introduction of a dimensionally small catheter to a specific site, which, once positioned, can be radially expanded to deploy a semirigid 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.

SoloPath, the first cardiovascular application of Controlled Deployment Technology, allows 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. a wide range of medical procedures.

For more information visit www.onsetmedical.com

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