ST. LOUIS, March 30, 2016 (GLOBE NEWSWIRE) -- Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, today announced that Takatsuki General Hospital, a leading acute care institution near Osaka, has reached the milestone of treating 120 patients using the Company’s Niobe® remote magnetic navigation system. This milestone completes the required patient enrollment for the Niobe system’s post-market surveillance (PMS) in Japan. Reviewed by Japan’s Pharmaceutical and Medical Devices Agency (PMDA), the PMS is used to monitor the safety and effectiveness of medical devices once they are on the market. Upon completion of six-month patient follow-up, Stereotaxis and its local representatives will submit final study data to the PMDA to satisfy all PMS requirements.
Stereotaxis gained market entry of the Niobe system in Japan in 2013. Takatsuki General Hospital represents the first installed Niobe lab in Japan, performing initial procedures in July 2015. Led by Dr. Kohei Yamashiro, the hospital has adopted magnetic navigation as its key treatment option for complex cardiac arrhythmias, citing its increased safety and catheter precision as integral benefits, and has performed case demonstrations to visiting physicians and executives from many Japanese hospitals interested in magnetic navigation. Dr. Yamashiro has also been invited to present his clinical experience on magnetic navigation at several scientific conferences for electrophysiology, most recently at Japan Circulation Society (JCS) on March 20.
“Successful ablation requires precise catheter positioning, often in complex heart chamber anatomy,” said Dr. Yamashiro. “With the Niobe system’s computer-aided, magnetic catheter guidance, we have achieved precise steering for more accurate lesions and greater safety, as well as reduced radiation exposure to both patients and physicians. Our first 120 patients have realized outstanding acute success in the treatment of their arrhythmias, without any major complications.”
Stereotaxis is a healthcare technology and innovation leader in the development of 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. Over 100 issued patents support the Stereotaxis platform, which helps physicians around the world provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis' core Epoch® Solution includes the Niobe® ES remote magnetic navigation system, the Odyssey® portfolio of lab optimization, networking and patient information management systems, and the Vdrive® robotic navigation system and consumables.
The core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, Canada, China, Japan, and elsewhere. The V-Sono™ ICE catheter manipulator, V-Loop™ variable loop catheter manipulator, and V-CAS™ catheter advancement system have received clearance in the United States, Canada, and the European Union. For more information, please visit www.stereotaxis.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, the Company's ability to raise additional capital on a timely basis and on terms that are acceptable, its continued listing on the NASDAQ Capital Market, its ability to continue to manage expenses and cash burn rate at sustainable levels, its ability to continue to work with lenders to extend, repay or refinance indebtedness on acceptable terms, 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 its systems and the timing of such purchases, competitive factors, changes resulting from the recently enacted healthcare reform in the United States, 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.
STXS Company Contact: Martin Stammer Chief Financial Officer 314-678-6155 STXS Investor Contact: Todd Kehrli / Jim Byers MKR Group, Inc. 323-468-2300 firstname.lastname@example.org