Route 92 Medical announced today that it received CE mark for its line of neurovascular intervention products for treating stroke. The company also picked up clearance under the MDSAP program, giving broad access to international markets. Authorization covers the majority of the company’s products, including: HiPoint 70/Tenzing 7 Reperfusion System HiPoint 88/Tenzing 8 Reperfusion System […]
Stroke
Imperative Care completes $150M Series E, Shacey Petrovic becomes vice chair of board
Imperative Care today announced the initial close of an oversubscribed Series E financing and appointed Shacey Petrovic to vice chair of its board of directors. The Campbell, California-based stroke treatment company is expected to raise up to $150 million in a financing round led by Ally Bridge Group. Existing investors, including D1 Capital Partners, Amed […]
How Imperative Care seeks to change the game in stroke treatment
With a new organizational structure meant to accelerate growth, Imperative Care is seeking to improve care even more for people with strokes and other ischemic diseases. There is an urgent need for better stroke care. Strokes hit a new person every 40 seconds in the U.S. — and kill someone about every 3 minutes, according […]
Study backs Philips’ direct-to-angio stroke pathway
Philips announced today that a published analysis supports its stroke care pathway. Amsterdam-based Philips had results of the health economic analysis published in the Journal of NeuroInterventional Surgery (JNIS). Data demonstrated that the company’s approach to stroke care reduced costs by an average of $3,120 per patient. Philips’ retrospective analysis looked at data from the […]
Abbott says study backs Amplatzer Amulet against Boston Scientific’s Watchman
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 […]
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 […]
