April 29, 2022 – Abbott announced U.S. availability of its Amplatzer™ Steerable Delivery Sheath, which is used with the company’s Amplatzer Amulet™ Left Atrial Appendage (LAA) Occluder to treat people with atrial fibrillation (AFib) who are at risk of ischemic stroke. The latest addition to Abbott’s comprehensive structural heart portfolio, this first-of-its kind delivery system demonstrates the company’s commitment to innovating across heart conditions, including in LAA occlusion (closure).
The LAA is a small pouch connected to the upper left chamber of the heart. The most common persistent arrhythmia, or irregular heartbeat, AFib disrupts the heart’s ability to effectively pump blood. If this condition is left untreated, blood can pool and collect in the LAA and increase the likelihood of a clot forming and traveling to the brain to cause a stroke. For patients with AFib who are unable to take blood-thinning medication long term, physicians may opt for a minimally invasive procedure using devices like Abbott’s Amulet to seal off the LAA entirely and reduce the risk of stroke.
Abbott’s Amulet with dual-seal technology (consisting of a lobe or piece to fill the cavity of the LAA and a disc to close off the opening into the LAA) offers immediate and complete closure of the LAA. This reduces the risk of stroke and – unlike competitive devices – does not require blood-thinning medication following the procedure, which is significant since these medicines often carry bleeding risks.
To improve physician ease-of-use when implanting the Amulet device, the Amplatzer Steerable Delivery Sheath features bi-directional steering and an “auto-lock” function that provides confidence the sheath will remain in its desired position. The delivery system also includes a valve designed to stabilize blood flow and minimize blood loss during the procedure.
The availability of the Steerable Delivery Sheath follows recent back-to-back achievements for Abbott’s LAA offering, including:
- Strong clinical evidence from the Amulet IDE trial, the largest randomized LAA occlusion study to date, confirmed that the Amplatzer Amulet offers durably superior LAA closure compared with the Watchman‡ device (Boston Scientific) at 45 days (presented at ESC Congress 2021) as well as at 12 months (presented at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium in 2021).
- Analysis presented at the International Stroke Conference 2022 demonstrated that device-related adverse events (peri-device leak and device-related thrombus) were seen more frequently in the Watchman device than Amulet.
- Data presented at TCT in 2021 confirmed the advantage of Amplatzer Amulet vs. Watchman (including Watchman FLX) in relation to the rate of occlusion of the LAA (SWISS-APERO), and peri-device leak with Amulet at both the disc and the lobe was lower than Watchman FLX (SEAL FLX).