Stereotaxis Announces European Adoption Milestone and Health Canada Market Clearance for Vdrive(TM) System
ST. LOUIS, Feb. 8, 2012 /PRNewswire/ — Stereotaxis, Inc. (NASDAQ: STXS) today announced that its Vdrive(TM) Robotic Navigation System, which provides physicians the ability to remotely manipulate traditionally non-robotic catheters, is growing in popularity and is expected to surpass 500 clinical procedures in Europe in February. The company also announced it has received regulatory clearance from Health Canada to commercially market the device in Canada.
Since the initial product release in Europe in 2011, the Vdrive system has been installed in nine centers, with units scheduled to be installed in additional centers during the first quarter of 2012. The initial nine centers have performed 473 clinical cases with approximately 80% being completed in the left atrium of the heart.
Numerous cases have been performed with the Vdrive(TM) system and clinical feedback continues to be very positive,” said Michael P. Kaminski, President and CEO of Stereotaxis. “With the Health Canada market clearance for the Vdrive system, and our planned new Vdrive installations in Europe and Canada this year, we are well-positioned to drive the growth and further adoption of this exciting technology in electrophysiology labs in these important markets.”
In a fully remote procedure environment, the Vdrive system increases the clinical techniques available to the physician and reduces the need to re-enter the sterile field to adjust devices. Initial clinical data from European physicians demonstrates that this simplification saves 30 minutes(1) or more in robotic procedures, depending on the individual clinical technique. Furthermore, the addition of robotic diagnostic catheter manipulation is another step in Stereotaxis’ vision to improve device control. Stereotaxis’ broad Epoch(TM) solutions portfolio also includes precise magnetic control of ablation catheters with Niobe® ES and integrated display and control of multiple lab technologies with the Odyssey(TM) Clinical Information Management System.
The design of the Vdrive system allows the robotic hardware to adapt to different clinical techniques depending on the disposable adaptor that is attached to the arm:
- V-Loop(TM) circular catheter manipulator allows control of circular diagnostic catheters, primarily in left atrial procedures.
- V-CAS(TM) catheter advancement system allows advancement and retraction of the magnetic catheter as well as robotic manipulation of catheter introducer sheaths that are already in use during the procedure.
- V-CAS Deflect(TM) catheter advancement system is a more advanced device that includes an integrated robotic deflectable sheath.
Initial positive results from multiple physician users confirmed the significant clinical value delivered by the Vdrive system related to procedure efficiency.
- Dr. Georg Noelker of the Herz- und Diabeteszentrum NRW in Bad Oeynhausen, Germany commented on the V-Loop system: “We have adopted Vdrive for navigating the circular mapping catheter for all of our left atrial procedures. Our initial experience with Vdrive has shown that we can reduce our left atrial procedures times by approximately 30%, and can further reduce our fluoroscopy times by an additional 14% over our previous times with magnetic navigation alone.”
- Dr. Xu Chen of the Rigshospitalet in Copenhagen commented on the V-CAS system: “The addition of robotic sheath control to a magnetic procedure allows me to efficiently access even challenging areas of the heart chambers and focus on patient therapy instead of catheter control. The Vdrive control was intuitive and did not take long to implement as a part of my procedure. In difficult cases the Vdrive control even reduced my total procedure time.”
- Dr. Petr Neuzil of Homolce Hospital in Prague shared his perspective on the V-CAS Deflect system: “The advancements in the Vdrive technology use the best of previous magnetic and robotic systems to provide a new level of catheter control, which is expected to improve outcomes in ablation procedures.”
The regulatory milestone in Canada covers both the V-Loop circular catheter manipulator and the V-CAS catheter advancement system with sheath manipulator. The Company’s 510(k) submission for the V-Loop circular catheter manipulator is under review by the U.S. Food and Drug Administration.
(1) Stereotaxis data on file
Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Niobe® Remote Magnetic Navigation System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation and reduced x-ray exposure.
Stereotaxis’ Odyssey(TM) portfolio of products provides an innovative enterprise solution for integrating, recording and networking interventional lab information within hospitals and around the world. Odyssey(TM) Vision integrates data for magnetic and standard interventional labs, enhancing the physician workflow through a consolidated display of multiple systems and eliminating the challenge of interacting simultaneously with many separate diagnostic systems. The Odyssey Cinema(TM) Studio then captures a complete record of synchronized procedure data that can be viewed live or from a comprehensive archive of cases performed. Odyssey(TM) solution then enables hospitals to efficiently share live and recorded clinical data anywhere around the world to attract patients and promote collaboration.
The core components of the Stereotaxis systems have received regulatory clearance in the U.S., Europe, Canada and elsewhere. For more information, please visit www.stereotaxis.com and www.odysseyexperience.com.
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, continued acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase our systems and the timing of such purchases, our continued access to capital and financial resources, including our ability to negotiate financing and lending arrangements on terms that are acceptable, the outcome of various shareholder litigation recently filed against us, competitive factors, changes resulting from the recently enacted healthcare reform in the U.S., including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approvals, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.
SOURCE Stereotaxis, Inc.