Medtronic plc reported data from a head-to-head trial backing its Evolut TAVR system against competitor Edwards Lifesciences Corp.’s Sapien platform, and the data showed particular promise of the Evolut in patients with a small aortic annulus, which would appear to be most beneficial for women in particular.
Routine use of Impella CP in patients who had a heart attack with cardiogenic shock cut mortality by 12.7% at six months compared to standard care, researchers reported in a late breaking presentation at the American College of Cardiology Scientific Sessions in Atlanta.
A quick jury verdict that a biopharma official was guilty of insider trading validated the U.S. SEC’s broader view of what constitutes such trading and could ignite more SEC “shadow trading” investigations and allegations. Following an eight-day trial before the U.S. District Court for the Northern District of California and a little more than two hours of deliberation, a jury found April 5 that Matthew Panuwat violated national securities laws when he purchased short-term, out-of-the-money stock options in Incyte Corp. in 2016.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Onkos Surgical, Spirair, Venus Concept.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Asept, Boston Scientific, Gopath, MMI, Nucleai, Sansure, Sepsmart, Spinex.
Richmond Hill, N.Y.-based Ihealthscreen Inc. reported the granting of a patent from the USPTO for automated systems for predicting and detecting the onset of glaucoma.
The U.S. FDA announced a class I recall of single-use neurovascular guide catheters made by Medos International Sarl SA of Neuchatel, Switzerland, because of fractures in the device’s distal catheter shaft. The FDA stated that the issue, seen in the company’s Cerebase DA line of guide sheaths, has led Medos to recommend that customers quarantine any of the affected devices, although a root cause has not yet been identified.