Company: BSX
Filing Date: 2025-02-18
Form Type: 10-K
Source: 0000885725-25-000011
Chunk: 4

Company: BOSTON SCIENTIFIC CORP
Filing Date: 2025-02-18
Form: 10-K
Item: Item 1
Chunk 4
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AGENT™ Drug-Coated Balloon, which is designed to provide a targeted, therapeutic dose of anti-proliferative paclitaxel to the coronary lesion and minimize downstream particulates, 

•ACURATE neo2™ and ACURATE Prime™ Aortic Valve Systems for use in transcatheter aortic valve replacement (TAVR) procedures and 

•SENTINEL™ Cerebral Embolic Protection Systems, used to reduce the risk of stroke in TAVR procedures and is clinically proven to decrease cerebral embolization and its associated neurological effects.

In the first quarter of 2024, we received FDA approval of the AGENT™ Drug-Coated Balloon, the first drug-coated coronary balloon in the U.S., which is indicated to treat in-stent restenosis in patients with coronary artery disease and in the second quarter of 2024, initiated the U.S. launch.

In addition, in the third quarter of 2024, we received CE Mark and initiated the European launch of the ACURATE™ Prime™ Aortic Valve System, the company's next-generation transcatheter aortic valve replacement technology designed to treat severe aortic stenosis in patients across all surgical risk levels while also expanding the treatment range to patients with a larger anatomy.

Watchman

Our WATCHMAN FLX™ and WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Devices are designed to close the left atrial appendage in patients with non-valvular atrial fibrillation who are at risk for ischemic stroke and eligible for anticoagulation therapy. WATCHMAN™ is the first device to offer a non-pharmacologic alternative to oral anti-coagulants that has been studied in a randomized clinical trial and is the leading device in percutaneous LAAC globally. In the first quarter of 2024, we received FDA clearance and initiated the U.S. launch of the WATCHMAN TruSteer™ Access System, a steerable sheath designed to improve implant success of the WATCHMAN FLX™ Pro and WATCHMAN FLX™ LAAC Devices.

Cardiac Rhythm Management

Our Cardiac Rhythm Management (CRM) business unit develops and manufactures a variety of implantable devices that monitor the heart and deliver electricity to treat cardiac abnormalities. Our product offerings include the following: 

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•the RESONATE™ family of implantable cardioverter defibrillators (ICD) and implantable cardiac resynchronization therapy defibrillators (CRT