Haemonetics Corporation has announced CE mark certification and the first commercial European procedures for the SavvyWire pre-shaped pressure guidewire.
The SavvyWire guidewire is described by Haemonetics as the world’s first and only sensor-guided three-in-one solution for transcatheter aortic valve implantation (TAVI), designed to improve procedural efficiency with predictable wire performance, hemodynamic measurement and left-ventricular (LV) pacing capabilities.
The certification will allow Haemonetics, which added the SavvyWire guidewire to its product portfolio with its acquisition of OpSens in December 2023, to engage in the next steps of country-specific entrance of the SavvyWire guidewire into the European Union (EU) and other geographies that recognise CE marking.
The first commercial European procedures using the SavvyWire guidewire were performed 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 engineered to support multiple steps over the same guidewire, reducing procedural device exchanges, providing stable aortic valve delivery and positioning while continuously monitoring cardiac haemodynamics. Additionally, it has been designed to enable reliable LV pacing without need for adjunct devices or venous access for conventional right ventricular pacing during TAVI procedures.
“More than 20 years after the first introduction of TAVI in France, the SavvyWire guidewire brings unique capabilities to European markets to help further streamline and optimise the procedure through efficient, predictable wire performance and LV pacing,” said Lionel Leroux from CHU Bordeaux.
Thomas Modine of CHU Bordeaux, added: “This wire marks an important step in the assessment of TAVI patients. With one wire in the same position, there are less manipulations and we are enabled to continuously monitor the patient’s haemodynamics.”
According to Pim Tonino from Catharina Ziekenhuis Eindhoven: “The SavvyWire guidewire raises the standard for haemodynamic measurements throughout the TAVI procedure, enabling physicians to make important procedural decisions immediately without having to exchange devices.”
“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,” said Stewart Strong, president, global hospital at Haemonetics. “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.”
