Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Sientra.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alivio Health, Biocept, Guardant, Menarini, Modular Medical, Neuroone Medical Technologies, Owlstone Medical, Softwave Tissue Regeneration Technologies, Zimmer Biomet Holdings.
The U.S. Department of Justice announced that a judgment of more than $487 million has been lodged against Cameron-Ehlen Group Inc., of Bloomington, Minn., for alleged violations of the False Claims Act (FCA) in connection with the company’s distribution of products used in cataract surgeries. That final amount is more than 10 times the amount alleged to have been billed illicitly to federal health programs, a clear signal that inducement of this sort will be met with severe penalties.
Amsterdam-based Royal Philips NV has posted the data from the complete set of third-party testing of the polyester-based polyurethane (PE-PUR) sound abatement foam used in its first-generation CPAP and other devices, and the news is not good for the U.S. FDA. These third-party evaluations have concluded that the foam used in these first-generation devices is unlikely to exert any “appreciable harm” to patients, a conclusion that runs directly counter to the FDA’s implicit argument about the foam.
Shockwave Medical Inc. enrolled the first patient in its EMPOWER CAD study, the first prospective, all-female study of percutaneous coronary intervention (PCI). The study seeks to confirm the benefits of coronary intravascular lithotripsy (IVL) in female patients with calcified lesions. Women have historically been underrepresented in cardiovascular trials and have had less favorable outcomes in response to therapies.
Elixir Medical Corp. reported that the Bioadaptor randomized controlled trial which compared its Dynamx coronary drug-eluting bioadaptor system to Dublin-based Medtronic plc’s Resolute Onyx drug-eluting stent (DES) in de novo native coronary arteries, met its primary endpoint of target lesion failure (TLF) non-inferiority at 12 months. The results were presented at a late-breaking clinical session during the EuroPCR 2023 conference in Paris.
Abbott Laboratories Inc. reported late-breaking data from the Bright study which showed that its Triclip transcatheter edge-to-edge repair (TEER) system reduced tricuspid regurgitation and improved the quality of life of patients with leaky tricuspid valves. The results from the largest real-world dataset were presented, for the first time, at the EuroPCR 2023 conference in Paris.
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