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BioWorld - Sunday, May 22, 2022
Home » Topics » Clinical, BioWorld MedTech

Clinical, BioWorld MedTech
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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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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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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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Women taking notes during EurpPCR presentation
EuroPCR

Boston Scientific touts TAVR data for second generation Neo2 valve

May 17, 2022
By Catherine Longworth
No Comments
The second generation of Boston Scientific Corp.’s Acurate Neo2 valve has demonstrated better performance than its predecessor, showing a threefold reduction of paravalvular leakage (PVL) said researchers. During the hotline/late-breaking trials session on May 17 at the EuroPCR meeting held in Paris, Andrea Buono, interventional cardiologist at Fondazione Poliambulanza Istituto Ospedaliero in Brescia, Italy, presented results from a large study comparing the performance of Acurate Neo and Acurate Neo2 in 13 Italian centers.
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3-30-Medtronic-Symplicity-Spyral.png
EuroPCR

Medtronic offers new data backing RDN system for blood pressure control

May 17, 2022
By Catherine Longworth
No Comments
Medtronic plc has presented three-year data on its global, multicenter, blinded, randomized and sham-controlled renal denervation (RDN) clinical program Spyral HTN-ON MED during the late-breaking clinical trial session at EuroPCR on May 17. The trial enrolled 80 typical uncontrolled hypertensive patients, randomized to RDN or sham control.
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Tacticath

Abbott’s Tacticath scores high in persistent atrial fibrillation study

May 4, 2022
By Meg Bryant
No Comments
Abbott Laboratories reported results from its PERSIST-END study demonstrating that close to nine in 10 patients treated for persistent atrial fibrillation (AF) with its Tacticath contact force ablation, sensor-enabled (Tacticath SE) were free of symptoms of their arrhythmia over 15 months of follow-up. The study’s findings, which supported a November 2021 FDA approval for persistent AF, also showed significant improvement in patients’ quality of life and a more than 50% cut in the use of health care resources, the company said.
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Pro2cool device

Tectraum completes Pro2cool concussion therapy study

May 4, 2022
By Meg Bryant
No Comments
Hypothermic therapy startup Tectraum Inc. has finished enrolling patients in a pivotal trial of its Pro2cool device for the treatment of concussion. The company expects to submit the results to the U.S. FDA to support regulatory clearance by the end of this year and commercially launch Pro2cool in the U.S. in the first quarter of 2023.
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Axess device and logo

Xeltis touts preliminary data for restorative hemodialysis access graft

May 4, 2022
By Catherine Longworth
No Comments
Xeltis BV plans to expedite an international pivotal trial investigating its restorative hemodialysis access graft Axess following encouraging preliminary data. The company released results from a clinical trial investigating the graft at CX 2022, the Charing Cross International Symposium on Vascular and Endovascular Challenges, in London. Data showed the graft had 100% functional patency and safety in a patient cohort of 11, with a median follow-up of 6.5 months.
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