Transcatheter LAA closure devices are starting to amass the level of data required to demonstrate their safety and effectiveness, and, if all goes well, the long-awaited FDA approval of the first such device – Boston Scientific’s Watchman – could finally occur sometme next year. Although LAA closure devices have already taken off in some European countries, US physicians continue to struggle with lingering uncertainties, about the learning curve, procedural safety and how LAA closure will stack up against newer anticoagulant drugs. Regardless of how these issues are eventually resolved, industry leaders see a big opportunity for a successful device in the LAA closure space, with market estimates of $1 billion considered conservative by some.
Whether they turn out to be revolutionary advances or something far less relevant, the promising devices now in development to block off the opening to the heart’s left atrial appendage (LAA; a small, pouch that branches off the left atrium) could be a godsend to millions of patients suffering from atrial fibrillation (AF) who are taking lifelong anticoagulant drugs. AF affects more than four million Americans, and worldwide that number is expected to rise to 16 million by 2050.
LAA closure devices fall into two basic categories: epicardial devices used during surgical procedures that are designed to close the...
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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.
Thena Capital, the first UK-based early-stage specialist medtech firm, has made its first investment since closing its £50m fund. Medtech Insight spoke with general partner Pamela Walker Geddes to gain insight into Thena Capital’s investment strategy.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
