Abbott (NYSE:ABT) today presented data supporting the use of its Amplatzer Amulet against Boston Scientific’s (NYSE:BSX) competing device. Device-related factors and all-cause death represented categories favoring Amplatzer Amulet against Watchman, according to a news release. Abbott designed its Amplatzer Amulet left atrial appendage (LAA) occluder with dual-seal technology. It features a lobe or piece to fill the […]
Stroke
FDA approves expanded label for Boston Scientific Watchman FLX
Boston Scientific (NYSE:BSX) announced today that the FDA approved expanded labeling for its Watchman FLX LAAC device for stroke prevention. The approval includes labeling with a 45-day dual anti-platelet therapy (DAPT) option for the left atrial appendage closure device (LAAC). DAPT represents an alternative to 45-day oral anticoagulation (OAC) plus aspirin for post-procedural treatment of […]
MicroTransponder reports first commercial implantation of its stroke rehab neurostim system
MicroTransponder (Austin, Texas) recently announced the first commercial implantation of its Vivistim paired VNS system for chronic ischemic stroke rehabilitation. Dr. Charles Y. Liu, director of the University of Southern California Neurorestoration Center, and Dr. Jonathan J. Russin, director of the USC Neuro Revascularization Center, successfully placed the small Vivistim device under the skin of […]
Late-breaking data supports use of Boston Scientific’s S-ICD, Watchman FLX devices
Late-breaking data highlighted the effectiveness of Boston Scientific’s (NYSE:BSX) S-ICD technology and Watchman FLX device. Multiple trials, for which data was presented at the Heart Rhythm Society (HRS) Heart Rhythm 2022 conference, backed Marlborough, Massachusetts-based Boston Scientific’s subcutaneous implantable cardiac defibrillators (S-ICD) against transvenous ICDs (TV-ICD) — and the Watchman FLX left atrial appendage closure […]
Abbott announces U.S. launch of Amplatzer steerable delivery sheath for Amulet device
Abbott (NYSE:ABT) announced today that it made the Amplatzer steerable delivery sheath commercially available in the U.S. The Amplatzer steerable delivery sheath works with the Amplatzer Amulet left atrial appendage (LAA) occluder to treat people with AFib who are at risk of ischemic stroke According to a news release, the Amulet with dual-seal technology offers […]
Silk Road Medical grows sales 33% in Q4
Silk Road Medical (NSDQ:SILK) posted fourth-quarter results that beat the revenue consensus on Wall Street and missed on earnings estimates. The Sunnyvale, California-based stroke treatment tech company reported losses of -$14.7 million, or -42¢ per share, on sales of $28.3 million for the three months ended Dec. 31, 2021, for a bottom-line gain of 12.3% […]
Women may have more adverse events with left atrial appendage occlusion devices than men
Women appear more likely than men to experience adverse events or lengthened hospital stays from left atrial appendage occlusion (LAAO) devices, the FDA announced today. In a letter to health care providers, the FDA said researchers have yet to determine the reason for the difference — and that it is working with device makers to […]
Rapid Medical raises $50M to support its minimally invasive stroke treatments
Rapid Medical has completed an oversubscribed Series D financing worth $50 million, with money slated to support rapid worldwide commercialization of the Yokeam, Israel–based company’s minimally invasive stroke treatment tech. The money raised comes on the heels of FDA clearance of the company’s Tigertriever revascularization device to treat ischemic stroke. Touted as a new class […]
FDA OKs new clinical trial for Abbott’s Amplatzer stroke prevention device
FDA has approved a clinical trial that will pit Abbott’s Amplatzer Amulet stroke prevention device against a newer class of blood thinners that are the present standard of treatment. Officials at Abbott (NYSE:ABT) think data from the new Catalyst trial could alter clinical practice, eliminating the need for some people with atrial fibrillation to take blood […]
Study: Mechanical thrombectomy no better than best medical care for stroke
An international study and meta-analysis have found that mechanical thrombectomy and best medical management produce similar results in stroke patients with emergency large-vessel occlusion and mild resulting deficits. Up to 10% of patients with emergency large-vessel occlusion treated within six hours can have mild deficits and deteriorate rapidly or gradually, leaving physicians in a conundrum […]
Medtronic inks deal for Viz.ai’s stroke tech
Medtronic (NYSE:MDT) said today that it inked a deal to distribute the stroke-detection software developed by Viz.ai. San Francisco-based Viz.ai’s LVO Stroke platform is designed to analyze computed tomography results and notify providers of potential strokes. The technology won 510(k) clearance from the FDA in February 2018. The deal with Fridley, Minn.-based Medtronic calls for […]
