Transcatheter aortic valve replacement (TAVR) devices continue to make a splash in the world of medical technology, with the Sapien 3 by Edwards Lifesciences Corp. leading the way. Results of the EARLY TAVR study strongly suggest a need for implant in asymptomatic patients with severe aortic stenosis, a development that should help sustain and possibly increase sales of these devices for the next few years.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Advanced Nanotherapies, Conavi, Corvia, Edwards, Roivios, Vahaticor.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Distalmotion, Paragonix Technologies, Vantis Vascular.
The third PCT family of patenting to emerge from IR Medtek LLC, and its first as the sole named assignee, sees its CEO, Douglas Cohen, continue to build protection for the company’s platform which uses a light detection technology and machine learning to improve the accuracy of cancer diagnosis.
The U.S. FDA cleared Paragonix Technologies Inc.’s Kidneyvault portable renal perfusion system, which combines digital monitoring capabilities and hypothermic perfusion technology to preserve donor kidneys during transportation.
Some rare skin diseases not only reduce the quality of life of patients, but also can be devastating conditions, leading to amputations or death. At the 31st annual congress of the European Society of Gene and Cell Therapy (ESGCT), held last week in Rome, different laboratories showcased their approaches to editing mutations related to this group of diseases.
Medtronic plc added a second U.S. FDA pulsed field ablation (PFA) device approval to its scorecard with the agency’s greenlight for its Affera mapping and ablation system with the Sphere-9 catheter. Affera brings the first radiofrequency/PFA device to the cardiac ablation market and ups the ante in the PFA competition.
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