Haemonetics, a US-based provider of blood and plasma supplies and services, has received the CE Mark certification for its SavvyWire pre-shaped pressure guidewire.
The SavvyWire guidewire is said to be the world’s first and only sensor-guided 3-in-1 device for transcatheter aortic valve implantation (TAVI). It is designed to enhance procedural efficiency by combining predictable wire performance with haemodynamic measurement and left-ventricular (LV) pacing capabilities.
The guidewire was originally developed by OpSens, which was acquired by Haemonetics in December 2023.
OpSens secured the US Food and Drug Administration (FDA) clearance in 2022 for use of SavvyWire guidewire for transcatheter aortic valve replacement procedures (TAVR).
With the CE Mark certification, Haemonetics can now introduce the guidewire to various European Union countries and other regions that accept CE marking.
Haemonetics, which is based in Massachusetts, also announced the first commercial European procedures for the SavvyWire guidewire.
The initial commercial procedures took place this month at Hôpital Haut-Lévêque du Centre Hospitalier Universitaire (CHU) de Bordeaux in France and at Catharina Ziekenhuis Eindhoven in the Netherlands.
The SavvyWire guidewire is specifically designed to streamline multiple steps within a single guidewire, minimising the need for procedural device exchanges. It ensures stable delivery and positioning of the aortic valve while continuously monitoring cardiac haemodynamics.
In addition, the guidewire offers left-ventricular pacing capabilities without requiring additional devices or venous access, which is typically needed for conventional right-ventricular pacing during TAVI procedures.
Haemonetics global hospital president Stewart Strong said: “CE Mark certification for the SavvyWire guidewire is a key step in our strategic international expansion, as we continue to broaden our leadership and impact by creating greater access to critical interventional technologies that advance healthcare standards.
“We look forward to leveraging our strong global commercial infrastructure to bring the SavvyWire guidewire’s fibre optic sensor technology to Europe, the Middle East and Africa, and enable more physicians to optimise TAVI procedures to improve patient outcomes.”
Last month, the company announced a limited market release of its VASCADE MVP XL mid-bore venous closure device.
