MitraClip: Abbott's transcatheter mitral valve repair device kept well within the non-inferiority margin compared to surgery on the composite endpoint of freedom from death, from follow-up mitral valve surgery and from greater-than-mild mitral regurgitation after two years of follow-up, EVEREST II trial investigator Ted Feldman, M.D., NorthShore University Health System, reported May 25 at the EuroPCR conference in Paris. And in a one-year subgroup analysis, there was no statistical difference in safety and similar efficacy outcome in MitraClip patients with either functional or degenerative mitral regurgitation, he said. MitraClip attracted significant attention in March when Feldman reported it has met its one-year non-inferiority efficacy endpoint and 30-day superiority safety endpoint versus open surgery at the American College of Cardiology annual meeting (1"The Gray Sheet" March 22, 2010). The EuroPCR MR subgroup analysis is particularly important, said Michael Weinstein, a J.P. Morgan analyst, because it "suggests that Abbott will be able to target the entire [MR] market, significantly increasing the potential opportunity.
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Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.
Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.
Valued at over $1.9bn, ConcertAI is building on its pre-existing multi-agentic AI SaaS solution CARAai to bring life science customers the new Precision suite of applications: Precision Explorer, Precision Trials, Precision GTM and Precision360.
