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Friday, August 19, 2022

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CE MARK

Navitor, the Latest-Generation Transcatheter Aortic Valve Implantation System to Treat Aortic Stenosis Receives CE Mark

The latest-generation TAVI system features advancements to reduce or eliminate risk of blood leakage around valve implant. The non-surgical Navitor TAVI system offers best-in-class deliverability and access through small vessels, expanding treatment options for patients with severe aortic stenosis.

Acutus Medical Announces CE Mark Approval for Suite of Next Generation EP Products in Europe

Expanded and product portfolio strengthens offering in access and therapy guidance>

EDGe Surgical Receives CE Mark Certification for EDG® Ortho 65mm Electronic Depth Gauge

Enables EDGe Surgical to gain access to markets that accept CE-marked medical devices.

aPROMISE Receives CE Mark Reports EXINI Diagnostics AB (Subsidiary of Lantheus Holdings)

aPROMISE includes a solution for automated body segmentation and marking, quantifying and reporting suspicious lesions in their anatomical context. The AI tool provides enhanced consistency in quantitative analysis and is intended to increase efficiency, accuracy and reproducibility of PSMA PET/CT image assessments.

Evolut PRO+ TAVI System Receives CE Mark Reports Medtronic

The approval follows a recent indication expansion for the Evolut platform in Europe for patients with severe aortic stenosis who are at a low risk of surgical mortality and patients with bicuspid aortic valves who are at intermediate, high and extreme risk of surgical mortality.

SenSight Directional Lead System for DBS Therapy Receives CE Mark Approval

"Medtronic has been driving innovation in DBS therapy for more than 25 years and the approval of the SenSight directional lead system in the EU is our latest contribution to the quest for improved patient experiences and clinical outcomes," said Mike Daly, vice president and general manager of Brain Modulation within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic.

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