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BioWorld - Monday, May 23, 2022
Home » Topics » Clinical

Clinical
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Presentation on the EuroPCR 2022 main stage
EuroPCR

Medtronic touts data for Resolute Onyx, Picardia data indicates TAVR shortcut

May 20, 2022
By Catherine Longworth
No Comments
Following last week’s FDA approval of its Onyx Frontier drug eluting stent (DES), Medtronic plc released results at EuroPCR from a real-world, multicenter prospective study using its Resolute Onyx platform for percutaneous coronary interventions (PCI) in the left main artery. Rehovot, Israel-based Pi-Cardia Ltd. also released early data for patients treated with its Short Cut transcatheter device for coronary obstruction prevention.
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Foghorn’s phase I in AML on a partial clinical hold

May 20, 2022
By Lee Landenberger
No Comments
In the wake of a patient’s death, the U.S. FDA has placed a partial clinical hold on Foghorn Therapeutics Inc.’s phase I study of FHD-286 in treating relapsed and/or refractory acute myelogenous leukemia (r/r AML) and myelodysplastic syndrome.
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Athersys sees 'Treasure' in stroke data, despite trial's missed endpoint

May 20, 2022
By Michael Fitzhugh
No Comments
Shares of Athersys Inc. fell sharply May 20 after its partner and top investor Healios K.K. reported that Multistem (invimestrocel), the experimental cell therapy they've co-developed since 2016, missed the primary endpoint of a Japanese phase II/III ischemic stroke study called Treasure.
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EuroPCR

1-year data for next-generation Navitor valve shows improved AS outcomes

May 19, 2022
By Catherine Longworth
No Comments
Abbott Laboratories Inc. presented one-year outcomes from its PORTICO NG study assessing the latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor in patients with severe aortic stenosis. The valve, which includes a new active sealing cuff, builds on the company’s Portico transcatheter heart valve platform.
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EuroPCR meeting in Paris
EuroPCR

Abbott report real-world outcomes for Triclip device

May 19, 2022
By Catherine Longworth
No Comments
Abbott Laboratories Inc. reported 30-day results from its Triclip Bright Study at the EuroPCR meeting in Paris on May 19. The real-world outcomes showed that the company’s tricuspid repair systems Triclip and Triclip G4 transcatheter edge-to-edge repair (TEER) significantly reduced tricuspid regurgitation (TR) and substantially improved the quality of life across a wide range of anatomically diverse patients.
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Respiratory syncytial virus, 3D illustration

Enanta forges on in RSV as phase IIb study fails

May 19, 2022
By Lee Landenberger
No Comments
Respiratory syncytial virus (RSV) continues to be a tough indication. Enanta Pharmaceuticals Inc.’s phase IIb study of otherwise healthy adults treated with EDP-938, an N-protein inhibitor, missed its primary endpoint of reduction in total symptom score compared to placebo. It also missed the study’s secondary antiviral endpoints.
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Youth COVID test

New findings help to identify those most at risk for developing severe COVID-19 complications

May 19, 2022
By Tamra Sami
No Comments
Findings from three recent studies are shedding light on the pathways that are activated in severe cases of COVID-19, paving the way for earlier diagnosis and more targeted treatments.
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EuroPCR meeting
EuroPCR

Jenavalve debut real-world results for Trilogy valve in severe AR patients

May 18, 2022
By Catherine Longworth
No Comments
Jenavalve Technology Inc. presented first real-world data for a study evaluating the safety and efficacy of its Jenavalve Trilogy transcatheter aortic valve implantation (TAVI) system for the treatment of severe aortic regurgitation (AR). The data, presented at the EuroPCR meeting on May 18, met the primary safety and efficacy endpoints with no major adverse events and no moderate or severe AR at discharge.
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R-One
EuroPCR

Robocath reports results from robotic coronary angioplasty study

May 18, 2022
By Catherine Longworth
No Comments
Robocath SAS presented results from the R-Evolution European clinical study assessing the safety and efficacy of its R-One robot for coronary angioplasty procedures. The study, which included 62 patients across six European centers, met all three primary endpoints, showing 100% clinical success, >95% technical success, and 84.5% average reduction in physician radiation exposure.
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Keros shares tumble amid doubts over early trial results from PAH candidate

May 18, 2022
By Richard Staines
No Comments
Keros Therapeutics Inc. announced preliminary results from a phase I trial of its engineered ligand trap KER-012 that gave its team confidence to proceed with larger studies in pulmonary arterial hypertension (PAH) and potentially some bone diseases. But company shares (NASDAQ:KROS) fell 16.6% to $38.50 May 18, following the announcement, perhaps over concerns about trial subjects that emerged in a company-hosted investor call.
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