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FEops’ HeartGuide Solution Studied in PRECISE-TAVI

December 12, 2022—Belgium-based FEops announced that transcatheter aortic valve implantation (TAVI) procedures planned by using the company’s HeartGuide were shown to result in important changes of preprocedural decision-making of the heart team, associated with favorable clinical outcomes.

First Patient in Europe Treated After Approval of CSI’s Diamondback 360 Coronary OAS

February 8, 2021—Cardiovascular Systems, Inc. (CSI) announced that the first patient in Europe has been treated with its Diamondback 360 coronary orbital atherectomy system (OAS).

European Postmarket Registry Begins for Essential Medical's Manta Large-Bore Vascular Closure Device

October 9, 2017—Essential Medical, Inc. announced the initiation of enrollment in a postmarket clinical registry of the company's Manta large-bore vascular closure device to be conducted in the regions where the device commercially available.

Boston Scientific Receives CE Mark Approval for 25-mm Lotus TAVR System

July 14, 2014—Boston Scientific Corporation announced that it has received European CE Mark approval for the 25-mm Lotus transcatheter aortic valve replacement (TAVR) system.

Vivasure’s PerQseal Elite Closure Device Study Enrolls First Patients

December 12, 2023—Vivasure Medical announced enrollment of the first patients in its ELITE clinical study of the PerQseal Elite, which is the latest generation of the company’s fully absorbable percutaneous large-hole vessel closure system.

Essential Medical's Manta Large-Bore Vascular Closure Device Approved in Europe

July 18, 2016—Essential Medical, Inc. announced that it has received European CE Mark approval for the company’s Manta large-bore vascular closure device.

Boston Scientific Initiates RESPOND Postmarket Registry of Lotus TAVR System

June 4, 2014—Boston Scientific Corporation announced that it has initiated the RESPOND postmarket registry to assess real-world performance of the Lotus valve system in transcatheter aortic valve replacement (TAVR) procedures.

Vivasure Commences ELITE-Venous Study of PerQseal Elite Vascular Closure System  

April 15, 2024—Vivasure Medical announced it has treated the first large-bore venous patient with the PerQseal Elite vascular closure system.

Abbott’s Navitor TAVR System Approved in Europe for Low- and Intermediate-Risk Patients

August 29, 2025—Abbott announced it has received European CE Mark approval for an expanded indication for the company’s Navitor transcatheter aortic valve replacement (TAVR) system to treat patients with symptomatic, severe aortic stenosis who are at low or intermediate risk for open heart surgery.

CSI’s Diamondback 360 Coronary Orbital Atherectomy System Approved in Europe

January 18, 2021—Cardiovascular Systems, Inc. (CSI) announced today that it has received European CE Mark approval for its Diamondback 360 coronary orbital atherectomy system (OAS) and ViperWire Advance coronary guidewire with Flex Tip.

ReCor's Ultrasound-Based Paradise System Approved in Europe for Renal Denervation

January 28, 2014—ReCor Medical, Inc. (Palo Alto, CA) announced that it has received European CE Mark approval for the latest generation of its ultrasound-based Paradise renal denervation system for the treatment of patients with resistant hypertension.

Medtronic’s Evolut Pro+ TAVR System Approved in Europe

May 3, 2021—Medtronic announced CE Mark approval of the Evolut Pro+ transcatheter aortic valve replacement (TAVR) system.

Enrollment Completed in EU Clinical Studies for Essential Medical's Manta Large-Bore Vascular Closure Device

February 1, 2016—Essential Medical, Inc. announced that it has completed enrollment of its European CE Mark clinical study of Manta, the company's large-bore vascular closure device.

Medtronic’s Evolut TAVR Device Assessed in Results From OPTIMIZE PRO and EVOLUT PRO Studies

November 27, 2024—Medtronic announced new data for the Evolut transcatheter aortic valve replacement (TAVR) system in the treatment of patients with symptomatic severe aortic stenosis (AS).