Johnson & Johnson completed the previously unheralded acquisition of privately held Laminar Inc. for $400 million upfront, with undisclosed contingent payments depending on achievement of clinical and regulatory milestones starting in 2024. The deal provides the med-tech giant a potentially game-changing entree into the lucrative left atrial appendage (LAA) market.
“The FDA approval to begin the Bivacor Total Artificial Heart EFS is a critical milestone for Bivacor and is another validation of the remarkable work and accomplishments of the entire Bivacor team. This device will provide a unique approach to help patients currently with limited clinical options,” said William Cohn, heart surgeon at the Texas Heart Institute and Bivacor chief medical officer.
The Cari-Heart, a medical imaging technology which detects signs of inflammation around coronary arteries, can predict the risk of a cardiac event, independent from clinical risk scores and the interpretation of coronary computed tomography angiography (CCTA), according to data from a study presented at the recent American Heart Association Scientific Sessions.
Xenter Inc. is seeking patent protection for capacitive micromachined ultrasonic transducer (CMUT) containing medical devices, including intraluminal devices such as guidewires and catheters comprising sensors for imaging and/or measuring of one or more physiological parameters.
Stanford University researchers are seeking patent protection for a medical device for performing endovascular surgical procedures, such as thrombectomy, rotablation, drug delivery and treating brain aneurysms. The device includes a magnetically actuated untethered rotation device, i.e., a magnetic spinner, that can navigate in blood vessels through its spinning-enabled propulsion.
The renal denervation hypothesis of hypertension was initially viewed with some skepticism, and Dublin-based Medtronic plc. endured a major setback when clinical trial data failed to make a compelling case for approval for the Symplicity Spyral. However, the company finally landed an FDA approval for the device, opening the gates to a new and significant market opportunity even with competition already on the market.
Surmodics Inc. reported positive two-year data from the SWING trial, the first-in-human study to look at the safety of its Sundance Sirolimus drug-coated balloon (DCB) when used to treat occlusive disease of the infrapopliteal arteries. Results presented at the VEITHsymposium in New York showed that the Sundance Sirolimus DCB demonstrated an excellent safety profile and achieved primary patency of 71.4% at 24 months in the per protocol analysis population.
Researchers from the University of Michigan have filed for patent protection of methods and systems to identify actual esophageal tissue changes and/or damage during cardiac ablation procedures.
Emboline Inc. is seeking patent protection for methods and apparatus for embolic protection during cardiac procedures being performed on atrial outlet valves, namely, the mitral and tricuspid valves.
Acutus Medical Inc. revealed plans after the Nasdaq closing bell on Nov. 8 to abandon the electrophysiology business as part of a massive restructuring that will leave the company entirely committed to manufacturing and distribution of Medtronic plc’s left-heart access products. The shift will put 65% of Acutus employees out of work and leaves the future of its cardiac ablation and mapping products up in the air.
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