08.01.13
Stereotaxis Inc. gained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Vdrive robotic navigation system with V-Sono intracardiac echocardiography (ICE) catheter manipulator. This is the first FDA clearance for the Vdrive family of products, which has been on the market in Europe since 2011.
“This is an exciting milestone for Stereotaxis,” said William Mills, Stereotaxis board chairman and interim CEO. “The Vdrive platform has added significant clinical value to a growing number of Niobe ES labs in Europe, and this V-Sono clearance should accelerate procedure growth in our U.S. installed base as well as open up an untapped, expanding electrophysiology (EP) market where ICE catheters are widely utilized. More than 68,000 ICE catheters are used in U.S. EP labs each year, a number that is growing at an annual rate of 15 percent.”
The Vdrive with V-Sono system is indicated for the remote control of compatible ICE (or ultrasound) catheters inserted into the right atrium. Vdrive with V-Sono system is designed to improve efficiency in a Niobe ES remote magnetic navigation procedure by enabling a single-operator workflow through eliminating the need for manual ICE manipulation inside the sterile and radiation field. Also, according to the company, procedural outcomes can be improved with the system’s precise, stable ultrasound imaging, and radiation exposure to the clinical team can be further reduced.
Stereotaxis makes robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. The company is based in St. Louis, Mo.
“This is an exciting milestone for Stereotaxis,” said William Mills, Stereotaxis board chairman and interim CEO. “The Vdrive platform has added significant clinical value to a growing number of Niobe ES labs in Europe, and this V-Sono clearance should accelerate procedure growth in our U.S. installed base as well as open up an untapped, expanding electrophysiology (EP) market where ICE catheters are widely utilized. More than 68,000 ICE catheters are used in U.S. EP labs each year, a number that is growing at an annual rate of 15 percent.”
The Vdrive with V-Sono system is indicated for the remote control of compatible ICE (or ultrasound) catheters inserted into the right atrium. Vdrive with V-Sono system is designed to improve efficiency in a Niobe ES remote magnetic navigation procedure by enabling a single-operator workflow through eliminating the need for manual ICE manipulation inside the sterile and radiation field. Also, according to the company, procedural outcomes can be improved with the system’s precise, stable ultrasound imaging, and radiation exposure to the clinical team can be further reduced.
Stereotaxis makes robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. The company is based in St. Louis, Mo.