Stereotaxis, Inc. is engaged in designing , manufacturing and marketing the Epoch Solution, which is an advanced remote robotic navigation system for use in a hospital's interventional surgical suite, or interventional lab. The Epoch Solution is consists of the Niobe ES Robotic Magnetic Navigation System (Niobe ES system), Odyssey Information Management Solution (Odyssey Solution), and the Vdrive Robotic Navigation System. The Company has alliances with Siemens, Philips and Biosense Webster. The Company has regulatory clearance, licensing and/or CE Mark approvals to market the Niobe Robotic Magnetic Navigation System, the Cardiodrive automated catheter advancement system, and various disposable interventional devices in the United States, Canada, Europe, China and various other countries.
Niobe ES Robotic Magnetic Navigation System
The Company’s Niobe ES robotic system provides the physician with remote digital instrument control through point and click computer mouse control, in combination with image integration and three dimensional (3D) reconstruction. It can be operated either from beside the patient table, as in traditional interventional procedures, or from a room adjacent to the patient and outside the x-ray fluoroscopy field. The Niobe ES robotic system allows the operator to navigate disposable interventional devices to the treatment site through paths in the blood vessels and chambers of the heart to deliver treatment by using computer controlled, externally applied magnetic fields to directly govern the motion of the working tip of these devices, each of which has a magnetically sensitive tip that predictably responds to magnetic fields generated by its system.
The Company has integrated its Niobe ES robotic system with Siemens’ and with Philips’ digital x-ray fluoroscopy systems. In addition, it have integrated the Niobe ES robotic system with Biosense Webster’s 3D catheter location sensing technology to provide real-time information as to the 3D location of the working tip of the instrument, and with Biosense Webster’s ablation tip technology. The components of the Niobe ES robotic system are Niobe Robotic Magnetic Navigation System, which utilizes two permanent magnets mounted on articulating and pivoting arms that are enclosed within a stationary housing, with one magnet on either side of the patient table. The Niobe ES robotic system is indicated for use in cardiac, peripheral and neurovascular applications and Cardiodrive Automated Catheter Advancement System, as the physician conducts the procedure from the adjacent control room, the Cardiodrive or QuikCAS automated catheter advancement systems are used to remotely advance and retract the electrophysiology catheter in the patient’s heart while the Niobe magnets steer the working tip of the device.
The Odyssey Solution offers a fully integrated, real-time information solution to manage, control, record and share procedures across networks or around the world. Through the use of a single mouse and keyboard, the Odyssey Solution allows the user to command multiple systems in the lab from a single point of control. In addition, the Odyssey Solution acquires a real-time, remote view of the lab capturing synchronized procedure data for review of important events during cases. The Odyssey Solution enables physicians to access recorded cases and create snapshots following procedures for enhanced clinical reporting, auditing and presentation. The Odyssey Solution enables physicians to establish a master archive of procedures performed in the lab providing a tool for training new staff on the standard practices. The Odyssey Solution further enables procedures to be observed remotely around the world with Internet access over a hospital VPN even wirelessly using a standard laptop or Windows tablet computer.
Vdrive Robotic Navigation System
The Vdrive Robotic Navigation System and Niobe ES robotic system provide independent remote manipulation of diagnostic catheters and magnetic ablation catheters in a single interface. The Vdrive Robotic Navigation System provides navigation and stability for diagnostic and ablation devices designed with features to assist in the delivery of better ablations. Features include complementing the Niobe ES control of catheters for fully remote procedures; enabling fully remote, single operator workflow; and providing robotic control of diagnostic devices independent of magnetic navigation. The Vdrive Duo system is an optional expansion of the Vdrive hardware that allows control of the V-loop device and either V-CAS or V-CAS Deflect devices in the same procedure, with a single user interface.
Disposables and Other Accessories
The Company’s Niobe system is designed to use a toolkit of disposable interventional devices. The toolkit consists of Cardiodrive or QuikCAS, which is automated catheter advancement disposables designed to provide e remote advancement of electrophysiology catheters; Cronus, Assert, Titan and Pegasus coronary guidewires, which is designed for use in interventional cardiology procedures for the introduction and placement of over-the-wire therapeutic devices, such as stents and angioplasty balloons; and Biosense Webster’s CARTO RMT navigation and ablation system, CELSIUS RMT, NAVISTAR RMT, NAVISTAR RMT DS, NAVISTAR RMT THERMOCOOL and CELSIUS RMT THERMOCOOL Irrigated Tip Diagnostic/Ablation Steerable Tip Catheters co-developed by Biosense Webster and Stereotaxis.
In addition to the Vdrive and Vdrive Duo systems, The Company also manufacture and market various disposable components, including V-CAS catheter advancement system that controls both the magnetic catheter body and a standard fixed-curve sheath; V-loop circular catheter manipulator, which allows the user to control certain circular mapping catheters, such as Biosense Webster’s LASSO2515 or LASSO2515 NAV Circular Mapping Catheter, and advance, retract, rotate, deflect and adjust loop radius, all without leaving the control room and V-CAS Deflect fully integrated catheter advancement system with a robotic deflectable sheath for
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