Vascular Devices

InspireMD's (NSPR) CE Mark Recertification to Boost CGuard EPS in February 2024
NSPR recently announced its receipt of CE Mark recertification under the European Union’s (EU) new Medical Device Regulation (MDR) regulatory framework.

The CE Mark certification under the MDR regulatory framework replaces the previous MDR framework, which controlled the approval and marketing of medical devices in the EU until May 2021.

Reflow Medical Receives CE Mark for Bare Temporary Spur Stent System for Treating de novo or Restenotic Below-the-Knee (BTK) Lesions in January 2024.

Reflow Medical, Inc., a developer of innovative medical devices focused on cardiovascular disease, announces it has received CE (Conformité Européenne) Mark certification in the European Union for the Bare Temporary Spur Stent System. 

The device is intended to treat de novo or restenotic lesions in the infrapopliteal arteries with a commercially available drug-coated balloon (DCB) to enhance drug absorption.

VentureMed’s FLEX system obtains European MDR Certification in September 2023.

VentureMed Group has received European Medical Device Regulation (MDR) certification for its FLEX Vessel Prep System.

The FLEX VP System, a non-balloon-based method for optimising revascularisation, has already received CE Mark and 510(k) clearance from the US Food and Drug Administration.

VentureMed president and CEO Denis Harrington said: “MDR certification demonstrates our commitment to quality and will enable continued commercial expansion of the FLEX Vessel Prep System into the CE-marked geographies.”

Cardiac Ablation devices:

Biosense Webster gains CE mark approval for new PFA system in February 2024

Biosense Webster, part of Johnson & Johnson MedTech, has gained CE mark approval for its Varipulse pulsed field ablation (PFA) system, giving cardiologists in Europe a new treatment option for atrial fibrillation (AFib).This new approval represents the latest sign that PFA, which uses electric pulses to ablate cardiac tissue as opposed to extreme temperatures, is gaining significant momentum around the world. In the United States, for example, Medtronic’s PulseSelect PFA system and Boston Scientific’s Farapulse PFA system both gained U.S. Food and Drug Administration (FDA) approval in recent months.

Medtronic scores double CE mark win for pulsed field ablation and cryoablation in November 21, 2023

Medtronic has received CE mark approval for its pulsed field system and cryoablation console devices used to treat atrial fibrillation. Medtronic stated the PulseSelect and Nitron console will be available in selected European countries in early 2024.

Adagio Medical Announces Completion of Enrollment in Cryocure-VT Trial, Maps the Pathway to CE-Mark of vCLAS™ VT Ablation Catheter in May 2023

Adagio Medical, Inc., a leading innovator in catheter ablation technologies for atrial fibrillation (AF) and ventricular tachycardia (VT), announced the completion of enrollment in its Cryocure-VT trial (NCT # 04893317) of ultra-low temperature cryoablation (ULTC) for the treatment of monomorphic ventricular tachycardias. 60 patients with ischemic and non-ischemic cardiomyopathies underwent an endocardial ULTC procedure using Adagio's vCLAS™ catheter at nine centers in the European Union and Canada. The results of the trial will be used to support Adagio's CE-mark application for its vCLAS catheter in the second half of 2023.

Medtronic’s Affera Mapping and Ablation System receives CE Mark March 2023

Medtronic has secured CE Mark for its Affera Mapping and Ablation System to treat atrial arrhythmias.The Affera system uses the Sphere-9 Catheter and the Affera Prism-1 Mapping Software. It has been designed to both map and ablate atrial arrhythmias, as well as provide real-time feedback through its intuitive mapping and navigation software.

The company stated that with the integration of the Sphere-9 pulsed field ablation (PFA), radiofrequency (RF) and high-density (HD) mapping catheter, the complete system creates a new paradigm in electrophysiology.

Structural Heart and Heart Failure:

Edwards receives CE Mark for MITRIS RESILIA valve in October 27, 2023
Edwards Lifesciences has obtained a CE Mark for the MITRIS RESILIA valve, a tissue valve replacement designed for the mitral position of the heart. The valve is produced using bovine pericardial tissue technology to minimise calcium accumulation. The saddle-shaped sewing cuff of the valve mimics the asymmetrical form of the native mitral valve.

Medtronic Evolut FX TAVI wins CE mark approval in October 2023

The Evolut FX is the latest generation TAVI of the company’s CoreValve/Evolut TAVI platform. Medtronic designed it to enhance ease-of-use and provide greater precision and control throughout the procedure for clinicians treating patients with severe aortic stenosis.

Edwards Lifesciences has secured European approval for its transcatheter tricuspid valve replacement system, which the company described as the first minimally invasive therapy of its kind to receive a regulatory green light in October 2023

The Evoque implant's new CE mark allows it to be sold in Europe alongside Edwards' Pascal system, a clip-like device that holds the tricuspid valve’s flaps together to form a tighter seal, and the Cardioband, which helps reshape and strengthen the outer ring structure of the valve.