Company: BSX
Filing Date: 2025-02-18
Form Type: 10-K
Source: 0000885725-25-000011
Chunk: 6

Company: BOSTON SCIENTIFIC CORP
Filing Date: 2025-02-18
Form: 10-K
Item: Item 1
Chunk 6
---
 efficient access to the left side of the heart,

•OPAL HDx™ Mapping System, catheter-based, 3-D cardiac mapping and navigation solutions designed to help diagnose and guide treatment of a variety of arrhythmias,

•a portfolio of radiofrequency (RF) cardiac ablation catheters, including our INTELLANAV STABLEPOINT™ catheter, which also includes DIRECTSENSE™ Software for monitoring RF energy during ablations and

•IntellaMap Orion™ Mapping Catheters, for use with our OPAL HDx™ Mapping System to provide high-density, high-resolution maps of the heart.

In the first quarter of 2024, we commenced the U.S. launch of the FARAPULSE™ PFA System. We received National Medical Products Administration (NMPA) approval in China and Pharmaceuticals and Medical Device Agency (PMDA) approval in Japan in the second and third quarter of 2024, respectively. In addition, in the third quarter of 2024, we received FDA approval for the navigation-enabled FARAWAVE™ NAV Ablation Catheter for the treatment of paroxysmal AF and FDA 510(k) clearance for the new FARAVIEW™ Software, which combine to provide visualization for cardiac ablation procedures with the OPAL HDx™ Mapping System.

Since the launch of the FARAPULSE™ PFA System, we have observed rapid conversion from legacy treatment modalities to PFA. It is now the predominant component of our Electrophysiology business unit and revenue.

Peripheral Interventions

Our Peripheral Interventions business unit develops and manufactures products to diagnose and treat peripheral arterial and venous diseases, as well as products to diagnose, treat and ease various forms of cancer. Our broad peripheral portfolio includes stent systems, balloon catheters, guidewires, atherectomy and thrombectomy systems, embolization devices, radioactive microspheres, radiofrequency and cryotherapy ablation systems, microcatheters, drainage catheters and transcarotid artery revascularization. 

6

Our peripheral arterial product offerings include:

•Eluvia™ Drug Eluting Vascular Stent Systems, innovative stents built on the Innova stent platform, designed to deliver a sustained dosage of paclitaxel during the time when restenosis is most likely to occur, in addition to the Eluvia™ line extension, the longest-length stent available for treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery,