Haemonetics obtains CE Mark certification for SavvyWire pre-shaped pressure guidewire

Haemonetics Corporation, a global medical technology leader, has received CE Mark certification for its SavvyWire pre-shaped pressure guidewire, marking the first commercial procedures in Europe. The SavvyWire is the world's first sensor-guided, 3-in-1 solution for Transcatheter Aortic Valve Implantation (TAVI), combining predictable wire performance, hemodynamic measurement, and left-ventricular (LV) pacing in a single device.

Following Haemonetics' acquisition of OpSens Inc. in December 2023, this certification enables the company to introduce SavvyWire across the European Union and other regions recognizing CE Marking. Initial procedures were successfully performed at Hôpital Haut-Lévêque in Bordeaux, France, and Catharina Ziekenhuis Eindhoven in the Netherlands.

SavvyWire is engineered to streamline TAVI procedures by reducing device exchanges, ensuring stable aortic valve delivery, and providing continuous cardiac monitoring, while enabling LV pacing without the need for additional devices.