Dive Brief:
- Stereotaxis has received Food and Drug Administration approval for a robotically navigated magnetic ablation catheter, the company said Tuesday.
- The approval positions users of Stereotaxis’ robotic electrophysiology systems to switch from an older Johnson & Johnson catheter to the newly approved Magic device.
- Stereotaxis will market the device alongside its GenesisX robotic system, which received 510(k) clearance last year and began a limited launch pending events including the catheter approval.
Dive Insight:
Physicians will use Stereotaxis’ catheter with its robot to perform ablation procedures that treat heart arrhythmias. The system allows healthcare professionals to steer the catheter toward target tissue using a computer interface.
The FDA authorized the ablation catheter for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli and creating endocardial lesions to treat supraventricular tachycardia. Physicians will use the catheter in patients with congenital heart disease in whom vascular or target chamber access by conventional manual catheter navigation is limited, either because of their anatomy or prior surgeries.
Stereotaxis CEO David Fischel said on a third-quarter earnings call in November that the catheter will replace an older J&J device previously used with the robot. The company has worked with J&J subsidiary Biosense Webster on disposables since 2002 and has revised and extended the deal over the years.
Fischel said on an earnings call in August 2024 that Stereotaxis has “been hampered clinically, commercially and strategically” by its dependence on the J&J catheter. The J&J device has a 20-year-old design that leaves “significant room for improvement and clinical performance,” Fischel said. Stereotaxis’ catheter is designed to have increased stability, more intuitive navigation and reduced fluid load.
The ablation catheter is part of a broader push to build a disposables business. Stereotaxis has launched the ablation catheter in Europe and its Magic Sweep high-density mapping catheter in the U.S. Winning FDA approval for the ablation catheter furthers the company’s attempt to generate recurring revenue by switching users to its own devices.
“Commercially, Stereotaxis receives no revenue or economic value from J&J sales of the current catheter, robbing us of the vast majority of disposable revenue in every robotic procedure,” Fischel said. “While we have a razor-blade business model, we’ve been giving up 80% of the razor blade.”
The GenesisX robotic system is the razor handle in Fischel’s analogy. Stereotaxis began a limited launch of the device last year and identified the catheter approval as a prerequisite for a wider rollout. The company is also working to ramp up production before full launch. Fischel said conferences such as Heart Rhythm 2026 in April would be the “latest natural time” to transition to the full launch.
