FDA approves next-gen pulsed field ablation catheter for paroxysmal atrial fibrillation
Click Here to Manage Email Alerts
Key takeaways:
- The FDA approved a navigation-enabled ablation catheter for the treatment of paroxysmal AF.
- New pulsed field ablation imaging software also received 510(k) clearance.
- Both technologies were immediately launched.
Boston Scientific announced it received FDA approval for its navigation-enabled ablation catheter for the treatment of paroxysmal atrial fibrillation and 510(k) clearance for new imaging software for its pulsed field ablation system.
The company announced the immediate commercial launch of its ablation catheter and imaging software after FDA approval and clearance (Farawave Nav and Faraview, respectively).
These technologies are only compatible with the company’s current mapping technology in addition to its latest mapping system designed to improve transfemoral access during radiofrequency and pulsed field ablation procedures (OPAL HDx), according to a company press release.
The navigation-enabled ablation mapping catheter is designed for use before pulsed field ablation to examine cardiac electrical patterns to assist planning of individualized procedures, according to the release.
In addition, the pulsed field ablation imaging software is designed to provide the physician user with a view of catheter placement, shape and rotation, according to the release.
“In clinical use, the Faraview software and Farawave Nav ablation catheter produced detailed cardiac maps that could improve guidance, limit fluoroscopy times and assist physicians in assessing the location of energy delivered during [ pulsed field ablation] procedures,” Vivek Reddy, MD, director of electrophysiology at Mount Sinai Fuster Heart Hospital, said in the release. “The addition of navigation and visualization capabilities to the Farapulse [pulsed field ablation] system could aid workflow efficiency and enhance the treatment physicians can provide to patients living with AF.”
Reference:
- Boston Scientific. OPAL HDx mapping system. https://www.bostonscientific.com/us/en/healthcare-professionals/products/mapping-and-navigation-systems/opal-hdx-mapping-system/fp00000293.html. Accessed Oct. 23, 2024.
Collapse
Click Here to Manage Email Alerts