ST. LOUIS, Aug. 26, 2020 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), the global leader in innovative robotic technologies for the treatment of cardiac arrhythmias, today announced a pioneering publication in the prestigious Journal of the American College of Cardiology (JACC) on the use of Stereotaxis’ robotic technology to treat pulmonary hypertension.
Dr. Alexander Romanov and colleagues at the National Medical Research Center in Novosibirsk, Russia led an investigator-initiated 50-patient, prospective, randomized, blinded, sham-controlled study of pulmonary artery denervation using Robotic Magnetic Navigation for patients with chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary endarterectomy. CTEPH is a severe form of pulmonary hypertension caused by blood clots that don’t dissolve in the lungs leading to progressive right heart failure. In the study, denervation of the pulmonary arteries was performed using a robotically-navigated ablation catheter. Patients receiving this treatment compared favorably across all efficacy and safety endpoints to those that received a sham procedure and were treated with best pharmaceutical care. At 12 months post-procedure, pulmonary vascular resistance was lower (p=0.001), pulmonary artery pressure was reduced (p=0.01), patients performed better on a 6-minute walk test (p=0.03), and hospitalization due to heart failure was reduced by 86% (p=0.049).
“Our results demonstrate that pulmonary artery denervation may serve as an important new therapy for residual chronic thromboembolic pulmonary hypertension,” said Dr. Romanov. “The use of robotic technology enables the success of such procedures by enhancing catheter precision and safety. We are proud to be pioneering new therapies that can improve medical care and hope that this technology will be further tested in patients with different types of pulmonary hypertension.”
“We are delighted to see the strength of clinical benefits shown in this pioneering study,” said David Fischel, Stereotaxis Chairman and CEO. “We have long known that Robotic Magnetic Navigation can broadly improve and enable interventional medicine. Pulmonary hypertension remains a disease with significant unmet medical need, and this therapy offers potential promise in one of the first non-arrhythmia indications for Stereotaxis to pursue.”
The publication can be found at https://www.onlinejacc.org/content/76/8/916. An editorial commenting on the publication can be found in the same journal at https://www.onlinejacc.org/content/76/8/927. To access the complete database of more than 400 scientific publications referencing Stereotaxis technology, visit www.RoboticEP.com/clinical-data/publications-database/.
Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. The core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, Japan, Canada, China, and elsewhere. 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 continue to manage expenses and cash burn rate at sustainable levels, 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 healthcare policy in the United States, including changes in government reimbursement of procedures, dependence upon third-party vendors, timing of regulatory approvals, the impact of the recent coronavirus (COVID-19) pandemic and our response to it, 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.
David L. Fischel
Chairman and Chief Executive Officer
Chief Financial Officer
Source: Stereotaxis, Inc.