Japan OKs Stereotaxis Robotic Cardiac Ablation Technology

Stereotaxis Inc., a maker of robotic cardiology instrument navigation systems, has been granted Japanese regulatory approval for its Niobe remote magnetic technology for cardiac ablations. The approval allows the company to begin marketing the product and establishing a local business infrastructure with domestic distributors while seeking reimbursement approval for full market entry. Reimbursement approval is expected by the end of 2013.

Approval by the Pharmaceuticals and Medical Devices Agency, Japan’s equivalent to the U.S. Food and Drug Administration, capped a successful three-year clinical trial of the Niobe system (pictured left) at the Tokyo Women’s Medical University. The clinical trial was led by Morio Shoda, M.D., and supported by Stereotaxis’ industry collaborators in Japan.

Niobe uses a soft catheter combined with computer control to navigate cardiac ablation procedures. Robotics generally are touted to increase repeatability and consistency in surgery.

William Mills, Stereotaxis board chairman, said the Japanese market—the second largest for medical devices behind the United States—represents a significant growth opportunity for the company. “An aging population, prominent cardiovascular institutions that embrace new technologies and favorable, universal health coverage create a very attractive environment for us to leverage our robotic navigation system,” said Mills. “Our entry into Japan provides opportunity for meaningful growth in the Asia Pacific region and marks a major step toward our vision of becoming the first choice in the treatment of complex electrophysiology ablations for the global marketplace.”

According to company data, there currently are 570 hospitals in Japan performing approximately 38,000 electrophysiology (EP) procedures annually, 45 percent of which are atrial fibrillation (AF) cases. With the highest life expectancy among developed nations—82.9 years—Japan has a rapidly growing senior population, currently at 23 percent and expected to reach 40 percent in the next 50 years. As AF and other arrhythmias develop in older individuals, the rate of EP ablations is anticipated to rise with the aging population. By 2018, industry analysts expect the country to experience 12 percent annual growth in EP procedures and a 22 percent annual increase in AF cases.

After the 2011 Tohoku earthquake and tsunami badly damaged the Fukushima Daiichi Nuclear Power Plant, the Japanese population is sensitive to elevated levels of radiation. According to Mills, Niobe has successfully reduced radiation exposure to physicians and patients—a feature which will be particularly attractive for Japanese patients.

Stereotaxis is headquartered in St. Louis, Mo.

Photo courtesy of Stereotaxis Inc.