Boston Scientific

Watchman trial finds single-drug regimens match dual therapy after heart implant

Sponsor of the SIMPLAAFY trial and maker of the Watchman FLX Pro device

Patients who receive the Watchman device to seal off the left atrial appendage usually leave the hospital on two antiplatelet drugs at once. The SIMPLAAFY trial, reported November 2 at the Transcatheter Cardiovascular Therapeutics meeting in San Diego and published in JAMA, tested whether one drug would do. Across 1,857 patients at 87 US sites, both a reduced-dose oral anticoagulant and aspirin alone matched dual antiplatelet therapy on death, stroke, systemic embolism and major bleeding at six months.

Updated Nov 3

Abbott wins FDA approval for patient-facing heart failure monitoring app

New Capabilities

Competitor in remote heart failure monitoring

Heart failure patients with Abbott's implanted pressure sensor will be able to see their own readings on a smartphone. The FDA approved the update on Oct. 5, 2026, and Abbott says the CardioGuide HF App will reach U.S. patients later in 2026.

Updated Oct 25

Boston Scientific recalls spinal cord stimulator leads after more than 1,000 serious injuries

Rule Changes

As of September 2026: Recalling unused Infinion CX leads; transitioning to Infinion Pro

Boston Scientific pulled unused spinal cord stimulator leads from the market after the FDA linked them to more than 1,000 serious injuries. The Infinion CX lead, which delivers electrical pulses to mask chronic pain, can fracture where it anchors to the spine.

Updated Sep 8

Boston Scientific pulls all Imager II catheters after tip-manufacturing defect

Rule Changes

As of September 2026: Discontinued the Imager II catheter line; directing customers to return product

Boston Scientific told hospitals to stop using every Imager II Angiographic Catheter it has sold. The tips were made with too little stabilizing agent, which raises the risk they could degrade and detach inside a patient's blood vessel.

Updated Sep 3

Medtronic wins first FDA approval for a defibrillation lead that paces through the heart's natural wiring

New Capabilities

As of May 2026: Competitor with FDA-approved pacing lead for left bundle branch area

For decades, defibrillators have saved lives by shocking dangerously fast rhythms back to normal, but the leads also pace the heart unnaturally and can cause damage over time. Medtronic's OmniaSecure lead is the first defibrillation lead that can pace through the heart's own electrical wiring, closely mimicking natural heartbeats. It has been cleared by the FDA for placement in the left bundle branch area.

Updated May 30