Stereotaxis Announces European Adoption Milestone and Health Canada Market Clearance for Vdrive™ System
Since the initial product release in
Numerous cases have been performed with the Vdrive™ system and clinical feedback continues to be very positive," said
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
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™ circular catheter manipulator allows control of circular diagnostic catheters, primarily in left atrial procedures.
- V-CAS™ 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™ 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 inCopenhagen 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 ofHomolce Hospital inPrague 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
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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
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Sam Duggan, Chief Financial Officer, +1-314-678-6007, or Media, Frank Cheng, Senior Vice President, Marketing & Business Development, +1-314-678-6111, both of Stereotaxis, Inc.; or Investors, Gregory Gin, +1-646-445-4801, or Doug Sherk, +1-415-568-4887, both of EVC Group, Inc., for Stereotaxis, Inc.