US-based Stereotaxis has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Vdrive Robotic Navigation System with V-Sono Intracardiac Echocardiography (ICE) catheter manipulator.
Although Stereotaxis’ Vdrive family of products has been in-use in Europe since 2011, this is the first clearance to be granted by the US regulatory agency for a Vdrive product.
Stereotaxis board chairman and interim chief executive officer William Mills noted that this is a significant milestone for the company.
"The Vdrive platform has added significant clinical value to a growing number of Niobe(R) ES labs in Europe, and this V-Sono clearance should accelerate procedure growth in our US installed base, as well as open up an untapped, expanding electrophysiology market where ICE catheters are widely utilised," Mills said.
According to the firm, more than 68,000 ICE catheters are used in the US EP labs every year, with this figure increasing at an annual rate of 15%.
Indicated for the remote control of compatible ICE or ultrasound catheters that are inserted into the right atrium, the Vdrive with V-Sono system, for a Niobe ES remote magnetic navigation procedure, can boost efficiency.
It allows a single-operator workflow and removes manual ICE manipulation inside the sterile and radiation field.
In addition, due to its exact and stable ultrasound imaging capabilities, procedural outcomes can be improved, while reducing radiation exposure to the clinical team.
The firm, based on a preliminary clinical input, believes that the Vdrive with V-Sono system will be able to offer similar benefits to procedures other than Niobe that use ICE catheters.
The Vdrive system, which was released in Europe in 2011, has so far been used in more than 2,000 clinical cases, with 100 having used the V-Sono disposable that was introduced in the market a year later.
Presently, as part of a 510(k) submission to the FDA, its Vdrive with V-Loop circular catheter manipulator is undergoing a five-centre investigational device exemption (IDE) study, which 120 patients are being enrolled on.